Frank Wesley Rockhold
Professor of Biostatistics & Bioinformatics
Frank is a full time Professor of Biostatistics and Bioinformatics and Faculty Director for Biostatistics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Strategic Consultant at Hunter Rockhold, Inc. His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance. He has held faculty appointments at six different universities. Dr. Rockhold served for 9 years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials and a past member of the PCORI Clinical Trials Advisory Panel. He is currently Chair of the Board of the Frontier Science and Technology Research Foundation and a technical advisor to EMA.
Dr. Rockhold has diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, safety and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. Frank is widely published in major scientific journals across a wide variety of research topics.
Frank holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. Frank is an Elected Fellow of both the American Statistical Association and the Society for Clinical Trials, a Fellow of the Royal Statistical Society, an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.
Current Research Interests
Pragmatic Clinical Trials
Clinical Trial Design
Data Monitoring Committees
Safety and Pharmacovigilance
Current Appointments & Affiliations
- Professor of Biostatistics & Bioinformatics, Biostatistics & Bioinformatics, Basic Science Departments 2021
- Member of the Duke Clinical Research Institute, Duke Clinical Research Institute, Institutes and Centers 2016
Contact Information
- 200 Morris Street, 6428 200 Morris, Durham, NC 27701
- Duke Box 3850, Durham, NC 27710
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frank.rockhold@duke.edu
(919) 668-1073
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Google Scholar
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HunterRockhold, Inc.
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LinkedIn
- Background
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Education, Training, & Certifications
- Ph.D., Virginia Commonwealth University 1979
- Sc.M., Johns Hopkins Unversity, Bloomberg School of Public Health 1977
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Previous Appointments & Affiliations
- Professor of Biostatistics & Bioinformatics, Biostatistics & Bioinformatics, Basic Science Departments 2016 - 2020
- Adjunct Professor in the Department of Biostatistics & Bioinformatics, Biostatistics & Bioinformatics, Basic Science Departments 2014 - 2016
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Leadership & Clinical Positions at Duke
- Interim Faculty Director Biostatistics, DCRI, 2022-
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Academic Positions Outside Duke
- Affiliate Professor of Biostatistics, Virginia Commonwealth University Medical Center. 2012 - 2022
- Adjunct Scholar, Epidemiology and Biostatistics, University of Pennsylvania School of Medicine. 2000 - 2010
- Adjunct Professor, Department of Public Health Sciences, Penn State University College of Medicine. 1995 - 2010
- Lecturer, Department of Quantitative Business Analysis, Indiana University School of Business Administration. 1983 - 1985
- Lecturer, Department of Management Science, Butler University School of Business Administration. 1979 - 1985
- Recognition
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In the News
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DEC 17, 2019 Scarab Alumni Magazine -
NOV 26, 2019 DCRI Pulse -
JUL 19, 2019 DCRI Pulse -
JUL 20, 2018 DCRI News -
JUL 20, 2018 Duke MedSchool Blog -
SEP 26, 2016 DCRI Pulse
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Awards & Honors
- Expertise
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Subject Headings
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Global Scholarship
- Research
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Selected Grants
- Integrated Biostatistical Training for CVD Research awarded by North Carolina State University 2022 - 2027
- Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss awarded by Patient Centered Outcomes Research Institute 2021 - 2025
- Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials (IMPACCT) awarded by Ann & Robert H Lurie Children's Hospital of Chicago 2021 - 2023
- HERO Program, HERO Registry, HERO-HCQ Trial awarded by Patient Centered Outcomes Research Institute 2020 - 2023
- ACTIV -6 awarded by National Institutes of Health 2016 - 2023
- RECOVER Infrastructure awarded by National Institutes of Health 2022 - 2023
- The ISCHEMIA Trial - SDCC awarded by National Institutes of Health 2011 - 2022
- ADAPTABLE Supplement awarded by Patient Centered Outcomes Research Institute 2015 - 2022
- ACT-EARLY awarded by Eidos Therapeutics 2021 - 2022
- Innovative statistical methodologies to subgroup analysis in clinical trials awarded by Brigham and Women's Hospital 2020 - 2021
- The ISCHEMIA Trial - SDCC- Subcontract with NYU awarded by New York University 2017 - 2019
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Fellowships, Supported Research, & Other Grants
- Addressing the clinical dilemma and patient preference for unilateral versus bilateral hearing aids awarded by PCORI 2020
- Innovative statistical methodologies to subgroup analysis in clinical trials awarded by FDA 2019
- EIDOS THERAPEUTICS EIDO-01 awarded by Eidos Therapeutics 2019
- PACT-ADDF awarded by Alzheimers Drug Discovery Foundation 2018 - 2021
- Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations (PREPARE) awarded by Patient-Centered Outcomes Research Institute 2018 - 2021
- BMS Clinical Trial Data Sharing Program awarded by Bristol-Myers Squibb 2017
- REA in 1VIT15043 Study awarded by Luitpold Pharmaceuticals 2017 - 2020
- The ISCHEMIA Trial - SDCC awarded by National Institutes of Health 2017 - 2020
- Phase III Stroke Trial awarded by ReNeuron Group 2017 - 2020
- Gemini Phase 3 awarded by Janssen Research & Development 2016 - 2017
- EXSCEL Cardiovascular Outcomes Study in Diabetes awarded by Amylin Pharmaceuticals 2016 - 2017
- GEMINI ACS 1 awarded by Janssen Research & Development 2016 - 2018
- ADAPTABLE awarded by Patient-Centered Outcomes Research Institute 2016 - 2020
- EUCLID Secondary Manuscripts awarded by AstraZeneca AB 2016 - 2020
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External Relationships
- Adaptic Health
- Adaptimmune Therapeutics Plc
- Alexion Pharmaceuticals, Inc.
- Alkermes, Inc.
- Amgen, Inc.
- AstraZeneca
- Athira Pharma
- Biogen
- Bristol Myers Squibb
- California Instiitute for Regenerative medicine
- Clover BioPharmaceuticals Australia
- Dr. Evidence
- Eli Lilly & Co.
- European Medicines Agency Technical Advisory Group
- Frontier Science and Research Technology Foundation
- Gilead Sciences, Inc.
- GlaxoSmithKline
- HunterRockhold, Inc.
- Icosavax
- Intercept Pharmaceuticals
- Janssen Research & Development
- Merck Research Laboratories
- Neurocrine Biosciences, Inc. (Diurnal)
- Novartis
- Odyssey Topco (financial holding company)
- Pfizer Inc.
- Pulmocide
- Resolve Therapeutics
- Roche/Genentech
- Sanofi
- Spencer Health Solutions
- UCB Pharma
- Publications & Artistic Works
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Selected Publications
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Academic Articles
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DeMets DL, Zarin DA, Rockhold F, Ellenberg SS, Fleming T, Wittes J. Bringing data monitoring committee charters into the sunlight. Clin Trials. 2023 May 25;17407745231169500.Full Text Link to Item
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Troy JD, Rockhold F, Samsa GP. Institutional approaches to preventing questionable research practices. Account Res. 2023 May;30(4):252–259.Full Text Link to Item
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Tadesse BT, Bravo L, Marks F, Aziz AB, You YA, Sugimoto J, Li P, Garcia J, Rockhold F, Clemens R, Household Contact Study Group. Impact of Vaccination With the SCB-2019 Coronavirus Disease 2019 Vaccine on Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Household Contact Study in the Philippines. Clin Infect Dis. 2023 Apr 3;76(7):1180–1187.Full Text Link to Item
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Sidhu MS, Alexander KP, Huang Z, Mathew RO, Newman JD, O’Brien SM, Pellikka PA, Lyubarova R, Bockeria O, Briguori C, Kretov EL, Mazurek T, Orso F, Roik MF, Sajeev C, Shutov EV, Rockhold FW, Borrego D, Balter S, Stone GW, Chaitman BR, Goodman SG, Fleg JL, Reynolds HR, Maron DJ, Hochman JS, Bangalore S, ISCHEMIA-CKD Research Group. Cause-Specific Mortality in Patients With Advanced Chronic Kidney Disease in the ISCHEMIA-CKD Trial. Jacc Cardiovasc Interv. 2023 Jan 23;16(2):209–218.Full Text Link to Item
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Chen J, Ho M, Lee K, Song Y, Fang Y, Goldstein BA, He W, Irony T, Jiang Q, van der Laan M, Lee H, Lin X, Meng Z, Mishra-Kalyani P, Rockhold F, Wang H, White R. The Current Landscape in Biostatistics of Real-World Data and Evidence: Clinical Study Design and Analysis. Statistics in Biopharmaceutical Research. 2023 Jan 1;15(1):29–42.Full Text
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Ho M, van der Laan M, Lee H, Chen J, Lee K, Fang Y, He W, Irony T, Jiang Q, Lin X, Meng Z, Mishra-Kalyani P, Rockhold F, Song Y, Wang H, White R. The Current Landscape in Biostatistics of Real-World Data and Evidence: Causal Inference Frameworks for Study Design and Analysis. Statistics in Biopharmaceutical Research. 2023 Jan 1;15(1):43–56.Full Text
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Levenson M, He W, Chen J, Fang Y, Faries D, Goldstein BA, Ho M, Lee K, Mishra-Kalyani P, Rockhold F, Wang H, Zink RC. Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment. Statistics in Biopharmaceutical Research. 2023 Jan 1;15(1):3–13.Full Text
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Wittes J, Fleming T, DeMets D, Ellenberg S, Gerstein H, Pfeffer M, Rockhold F, Yusuf S, Hennekens C. The Data Monitoring Committee: A Collective or a Collection? Therapeutic Innovation and Regulatory Science. 2023 Jan 1;Full Text
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Mathew RO, Maron DJ, Anthopolos R, Fleg JL, O’Brien SM, Rockhold FW, Briguori C, Roik MF, Mazurek T, Demkow M, Malecki R, Ye Z, Kaul U, Miglinas M, Stone GW, Wald R, Charytan DM, Sidhu MS, Hochman JS, Bangalore S. Guideline-Directed Medical Therapy Attainment and Outcomes in Dialysis-Requiring Versus Nondialysis Chronic Kidney Disease in the ISCHEMIA-CKD Trial. Circ Cardiovasc Qual Outcomes. 2022 Oct;15(10):e008995.Full Text Link to Item
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Abebe KZ, Rockhold FW. The Impact of Landscape Changes on Data and Safety Monitoring Board Oversight of Clinical Trials. Evans SR, Drazen J, editors. Nejm Evidence. Massachusetts Medical Society; 2022 Aug 23;1(9).Full Text Open Access Copy
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Chaitman BR, Cyr DD, Alexander KP, Pracoń R, Bainey KR, Mathew A, Acharya A, Kunichoff DF, Fleg JL, Lopes RD, Sidhu MS, Anthopolos R, Rockhold FW, Stone GW, Maron DJ, Hochman JS, Bangalore S. Cardiovascular and Renal Implications of Myocardial Infarction in the ISCHEMIA-CKD Trial. Circ Cardiovasc Interv. 2022 Aug;15(8):e012103.Full Text Link to Item
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Oddens BJ, Agaku IT, Snyder ES, Malbecq W, Wang WW, Kaplan KM, Koch GG, Rockhold FW. Exploratory analyses of clinical trial data used for health technology assessments: a retrospective evaluation. Bmj Open. 2022 Jul 29;12(7):e058146.Full Text Link to Item
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Smolenov I, Han HH, Li P, Baccarini C, Verhoeven C, Rockhold F, Clemens SAC, Ambrosino D, Richmond P, Siber G, Liang J, Clemens R, SPECTRA Study Group. Impact of previous exposure to SARS-CoV-2 and of S-Trimer (SCB-2019) COVID-19 vaccination on the risk of reinfection: a randomised, double-blinded, placebo-controlled, phase 2 and 3 trial. Lancet Infect Dis. 2022 Jul;22(7):990–1001.Full Text Link to Item
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Williams RJ, Dobbins HD, Tse T, Chon SD, Loose D, Sarosy GA, Prindiville SA, Rockhold FW, Zarin DA. Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis. Bmj. 2022 Jun 10;377:e067745.Full Text Link to Item
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Szarek M, Hess C, Patel MR, Jones WS, Berger JS, Baumgartner I, Katona B, Mahaffey KW, Norgren L, Blomster J, Rockhold FW, Hsia J, Fowkes FGR, Bonaca MP. Total Cardiovascular and Limb Events and the Impact of Polyvascular Disease in Chronic Symptomatic Peripheral Artery Disease. J Am Heart Assoc. 2022 Jun 7;11(11):e025504.Full Text Link to Item
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Behan SA, Mulder H, Rockhold FW, Gutierrez JA, Baumgartner I, Katona BG, Mahaffey KW, Norgren L, Jones S, Bonaca MP. Impact of Polyvascular Disease and Diabetes on Limb and Cardiovascular Risk in Peripheral Artery Disease. J Am Coll Cardiol. 2022 May 3;79(17):1781–1783.Full Text Link to Item
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Israel E, Cardet J-C, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang K-L, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505–1518.Full Text Link to Item
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Huang Z, Rockhold FW, Jones WS, Hernandez AF, McCall D, DeMets DL, Hochman JS, Gersh BJ, Campos H, Jacobs AK, Yancy CW. The challenges of data safety monitoring for a pragmatic study: Lessons from the ADAPTABLE study. Contemp Clin Trials. 2022 Apr;115:106732.Full Text Link to Item
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Larson K, Sim I, von Isenburg M, Levenstein M, Rockhold F, Neumann S, D’Arcy C, Graham E, Zuckerman D, Li R. COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic. Contemp Clin Trials. 2022 Apr;115:106709.Full Text Link to Item
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Narayanasamy S, Mourad A, Turner NA, Le T, Rolfe RJ, Okeke NL, O’Brien SM, Baker AW, Wrenn R, Rosa R, Rockhold FW, Naggie S, Stout JE. COVID-19 Trials: Who Participates and Who Benefits? South Med J. 2022 Apr;115(4):256–261.Full Text Open Access Copy Link to Item
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Sharma A, Mahaffey KW, Gibson CM, Hicks KA, Alexander KP, Ali M, Chaitman BR, Held C, Hlatky M, Jones WS, Mehran R, Menon V, Rockhold FW, Seltzer J, Spitzer E, Wilson M, Lopes RD. Clinical events classification (CEC) in clinical trials: Report on the current landscape and future directions - proceedings from the CEC Summit 2018. Am Heart J. 2022 Apr;246:93–104.Full Text Link to Item
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Briguori C, Mathew RO, Huang Z, Mavromatis K, Hickson LJ, Lau WL, Mathew A, Mahajan S, Wheeler DC, Claes KJ, Chen G, Nolasco FEB, Stone GW, Fleg JL, Sidhu MS, Rockhold FW, Chertow GM, Hochman JS, Maron DJ, Bangalore S. Dialysis Initiation in Patients With Chronic Coronary Disease and Advanced Chronic Kidney Disease in ISCHEMIA-CKD. J Am Heart Assoc. 2022 Mar 15;11(6):e022003.Full Text Link to Item
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Burns L, Roux NL, Kalesnik-Orszulak R, Christian J, Hukkelhoven M, Rockhold F, O’Donnell J. Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World. Clin Ther. 2022 Mar;44(3):420–437.Full Text Link to Item
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Norgren L, North R, Baumgartner I, Berger JS, Blomster JI, Hiatt WR, Jones WS, Katona BG, Mahaffey KW, Mulder H, Patel MR, Rockhold FW, Fowkes FGR. World regional differences in outcomes for patients with peripheral artery disease: Insights from the EUCLID trial. Vasc Med. 2022 Feb;27(1):21–29.Full Text Open Access Copy Link to Item
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Bravo L, Smolenov I, Han HH, Li P, Hosain R, Rockhold F, Clemens SAC, Roa C, Borja-Tabora C, Quinsaat A, Lopez P, López-Medina E, Brochado L, Hernández EA, Reynales H, Medina T, Velasquez H, Toloza LB, Rodriguez EJ, de Salazar DIM, Rodríguez CA, Sprinz E, Cerbino-Neto J, Luz KG, Schwarzbold AV, Paiva MS, Carlos J, Montellano MEB, de Los Reyes MRA, Yu CY, Alberto ER, Panaligan MM, Salvani-Bautista M, Buntinx E, Hites M, Martinot J-B, Bhorat QE, Badat A, Baccarini C, Hu B, Jurgens J, Engelbrecht J, Ambrosino D, Richmond P, Siber G, Liang J, Clemens R. Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2022 Jan 29;399(10323):461–472.Full Text Link to Item
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Facile R, Muhlbradt EE, Gong M, Li Q, Popat V, Pétavy F, Cornet R, Ruan Y, Koide D, Saito TI, Hume S, Rockhold F, Bao W, Dubman S, Jauregui Wurst B. Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey. Jmir Med Inform. 2022 Jan 27;10(1):e30363.Full Text Link to Item
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Levenson M, He W, Chen L, Dharmarajan S, Izem R, Meng Z, Pang H, Rockhold F. Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development. Statistics in Biopharmaceutical Research. 2022 Jan 1;Full Text
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Weissler EH, Mulder H, Rockhold FW, Baumgartner I, Norgren L, Blomster J, Katona BG, Fowkes FGR, Mahaffey K, Bonaca M, Patel MR, Jones WS. Understanding Study Drug Discontinuation Through EUCLID. Front Cardiovasc Med. 2022;9:947645.Full Text Link to Item
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Hsia J, Kavanagh ST, Hopley CW, Baumgartner I, Berger JS, Fowkes GR, Jones WS, Mahaffey KW, Norgren L, Patel MR, Rockhold F, Blomster J, Katona BG, Hiatt WR, Bonaca MP. Impact of chronic kidney disease on hemoglobin among patients with peripheral artery disease treated with P2Y12 inhibitors: Insights from the EUCLID trial. Vasc Med. 2021 Dec;26(6):608–612.Full Text Link to Item
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Pocock SJ, Rossello X, Owen R, Collier TJ, Stone GW, Rockhold FW. Primary and Secondary Outcome Reporting in Randomized Trials: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Aug 24;78(8):827–839.Full Text Link to Item
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Hiatt WR, Hess CN, Bonaca MP, Kavanagh S, Patel MR, Baumgartner I, Berger JS, Blomster JI, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Fowkes FGR. Ankle-Brachial Index for Risk Stratification in Patients With Symptomatic Peripheral Artery Disease With and Without Prior Lower Extremity Revascularization: Observations From the EUCLID Trial. Circ Cardiovasc Interv. 2021 Jul;14(7):e009871.Full Text Link to Item
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Salciccioli JD, She L, Tulchinsky A, Rockhold F, Cardet JC, Israel E. Effect of COVID-19 on asthma exacerbation. J Allergy Clin Immunol Pract. 2021 Jul;9(7):2896-2899.e1.Full Text Link to Item
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Zannad F, Cotter G, Alonso Garcia A, George S, Davison B, Figtree G, Prasad K, Rockhold F, Schilsky RL, Stockbridge N, Pitt B, Butler J. What can heart failure trialists learn from oncology trialists? Eur Heart J. 2021 Jun 21;42(24):2373–2383.Full Text Link to Item
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Samsky MD, Hellkamp A, Hiatt WR, Fowkes FGR, Baumgartner I, Berger JS, Katona BG, Mahaffey KW, Norgren L, Blomster JI, Rockhold FW, DeVore AD, Patel MR, Jones WS. Association of Heart Failure With Outcomes Among Patients With Peripheral Artery Disease: Insights From EUCLID. J Am Heart Assoc. 2021 Jun 15;10(12):e018684.Full Text Link to Item
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Axfors C, Schmitt AM, Janiaud P, Van’t Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen C-P, Chen T-C, Cheng S-H, Cheng C-Y, Chung W-S, Cohen YZ, Cowan LN, Dalgard O, de Almeida E Val FF, de Lacerda MVG, de Melo GC, Derde L, Dubee V, Elfakir A, Gordon AC, Hernandez-Cardenas CM, Hills T, Hoepelman AIM, Huang Y-W, Igau B, Jin R, Jurado-Camacho F, Khan KS, Kremsner PG, Kreuels B, Kuo C-Y, Le T, Lin Y-C, Lin W-P, Lin T-H, Lyngbakken MN, McArthur C, McVerry BJ, Meza-Meneses P, Monteiro WM, Morpeth SC, Mourad A, Mulligan MJ, Murthy S, Naggie S, Narayanasamy S, Nichol A, Novack LA, O’Brien SM, Okeke NL, Perez L, Perez-Padilla R, Perrin L, Remigio-Luna A, Rivera-Martinez NE, Rockhold FW, Rodriguez-Llamazares S, Rolfe R, Rosa R, Røsjø H, Sampaio VS, Seto TB, Shahzad M, Soliman S, Stout JE, Thirion-Romero I, Troxel AB, Tseng T-Y, Turner NA, Ulrich RJ, Walsh SR, Webb SA, Weehuizen JM, Velinova M, Wong H-L, Wrenn R, Zampieri FG, Zhong W, Moher D, Goodman SN, Ioannidis JPA, Hemkens LG. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials. Nat Commun. 2021 May 14;12(1):3001.Full Text Open Access Copy Link to Item
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Mentz RJ, Ambrosy AP, Ezekowitz JA, Lewis GD, Butler J, Wong YW, De Pasquale CG, Troughton RW, O’Meara E, Rockhold FW, Garg J, Samsky MD, Leloudis D, Dugan M, Mundy LM, Hernandez AF, HEART-FID Trial Investigators. Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and Design. Circ Heart Fail. 2021 May;14(5):e008100.Full Text Link to Item
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Zariffa N, Haggstrom J, Rockhold F. Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further. Ther Innov Regul Sci. 2021 May;55(3):558–560.Full Text Link to Item
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Axfors C, Schmitt AM, Janiaud P, Van’t Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen C-P, Chen T-C, Cheng S-H, Cheng C-Y, Chung W-S, Cohen YZ, Cowan LN, Dalgard O, de Almeida E Val FF, de Lacerda MVG, de Melo GC, Derde L, Dubee V, Elfakir A, Gordon AC, Hernandez-Cardenas CM, Hills T, Hoepelman AIM, Huang Y-W, Igau B, Jin R, Jurado-Camacho F, Khan KS, Kremsner PG, Kreuels B, Kuo C-Y, Le T, Lin Y-C, Lin W-P, Lin T-H, Lyngbakken MN, McArthur C, McVerry BJ, Meza-Meneses P, Monteiro WM, Morpeth SC, Mourad A, Mulligan MJ, Murthy S, Naggie S, Narayanasamy S, Nichol A, Novack LA, O’Brien SM, Okeke NL, Perez L, Perez-Padilla R, Perrin L, Remigio-Luna A, Rivera-Martinez NE, Rockhold FW, Rodriguez-Llamazares S, Rolfe R, Rosa R, Røsjø H, Sampaio VS, Seto TB, Shahzad M, Soliman S, Stout JE, Thirion-Romero I, Troxel AB, Tseng T-Y, Turner NA, Ulrich RJ, Walsh SR, Webb SA, Weehuizen JM, Velinova M, Wong H-L, Wrenn R, Zampieri FG, Zhong W, Moher D, Goodman SN, Ioannidis JPA, Hemkens LG. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials. Nat Commun. 2021 Apr 15;12(1):2349.Full Text Open Access Copy Link to Item
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Chaitman BR, Alexander KP, Cyr DD, Berger JS, Reynolds HR, Bangalore S, Boden WE, Lopes RD, Demkow M, Piero Perna G, Riezebos RK, McFalls EO, Banerjee S, Bagai A, Gosselin G, O’Brien SM, Rockhold FW, Waters DD, Thygesen KA, Stone GW, White HD, Maron DJ, Hochman JS, ISCHEMIA Research Group. Myocardial Infarction in the ISCHEMIA Trial: Impact of Different Definitions on Incidence, Prognosis, and Treatment Comparisons. Circulation. 2021 Feb 23;143(8):790–804.Full Text Link to Item
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Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, Pace WD, Maher NE, She L, Rockhold FW, Fagan M, Forth VE, Hernandez PA, Manning BK, Rodriguez-Louis J, Shields JB, Coyne-Beasley T, Kaplan BM, Rand CS, Morales-Cosme W, Wechsler ME, Wisnivesky JP, White M, Yawn BP, McKee MD, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang K-L, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A. A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial. Contemp Clin Trials. 2021 Feb;101:106246.Full Text Link to Item
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Richmond P, Hatchuel L, Dong M, Ma B, Hu B, Smolenov I, Li P, Liang P, Han HH, Liang J, Clemens R. Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial. The Lancet. Elsevier BV; 2021 Feb;397(10275):682–694.Full Text
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Galani J, Mulder H, Rockhold FW, Weissler EH, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Hiatt WR, Katona BG, Norgren L, Mahaffey KW, Quint JK, Patel MR, Jones WS. Association of Chronic Obstructive Pulmonary Disease with Morbidity and Mortality in Patients with Peripheral Artery Disease: Insights from the EUCLID Trial. Int J Chron Obstruct Pulmon Dis. 2021;16:841–851.Full Text Link to Item
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Mulcahey MJ, Jones LAT, Rockhold F, Rupp R, Kramer JLK, Kirshblum S, Blight A, Lammertse D, Guest JD, Steeves JD. Adaptive trial designs for spinal cord injury clinical trials directed to the central nervous system. Spinal Cord. 2020 Dec;58(12):1235–1248.Full Text Link to Item
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Lopes RD, Alexander KP, Stevens SR, Reynolds HR, Stone GW, Piña IL, Rockhold FW, Elghamaz A, Lopez-Sendon JL, Farsky PS, Chernyavskiy AM, Diaz A, Phaneuf D, De Belder MA, Ma Y-T, Guzman LA, Khouri M, Sionis A, Hausenloy DJ, Doerr R, Selvanayagam JB, Maggioni AP, Hochman JS, Maron DJ. Initial Invasive Versus Conservative Management of Stable Ischemic Heart Disease in Patients With a History of Heart Failure or Left Ventricular Dysfunction: Insights From the ISCHEMIA Trial. Circulation. 2020 Nov 3;142(18):1725–1735.Full Text Link to Item
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Gutierrez JA, Heizer GM, Jones WS, Rockhold FW, Mahaffey KW, Fowkes FGR, Berger JS, Baumgartner I, Held P, Katona BG, Norgren L, Blomster JI, Hiatt WR, Patel MR. CYP2C19 status and risk of major adverse cardiovascular events in peripheral artery disease: Insights from the EUCLID Trial. Am Heart J. 2020 Nov;229:118–120.Full Text Link to Item
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Kochar A, Mulder H, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Lopes RD, Al-Khalidi HR, Mahaffey KW, Norgren L, Hiatt WR, Patel MR, Jones WS. Cause of Death Among Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006550.Full Text Link to Item
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Lentz TA, Curtis LH, Rockhold FW, Martin D, Andersson TLG, Arias C, Berlin JA, Binns C, Cook A, Cziraky M, Dent R, Desai M, Emmett A, Esserman D, George J, Hantel S, Heagerty P, Hernandez AF, Hucko T, Khan N, Lee SF, LoCasale R, Mardekian J, McCall D, Monda K, Normand S-L, Riesmeyer J, Roe M, Roessig L, Scott R, Siedentop H, Waldstreicher J, Wang L, Weerakkody G, Wolf M, Ellenberg SS. Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting. Ther Innov Regul Sci. 2020 Nov;54(6):1477–1488.Full Text Link to Item
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Rymer JA, Mulder H, Smolderen KG, Hiatt WR, Conte MS, Berger JS, Norgren L, Mahaffey KW, Baumgartner I, Fowkes FG, Katona BG, Rockhold F, Jones WS, Patel MR. Association of Health Status Scores With Cardiovascular and Limb Outcomes in Patients With Symptomatic Peripheral Artery Disease: Insights From the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) Trial. J Am Heart Assoc. 2020 Oct 20;9(19):e016573.Full Text Link to Item
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Rymer JA, Mulder H, Narcisse DI, Rockhold F, Hiatt WR, Fowkes FG, Baumgartner I, Berger JS, Katona BG, Mahaffey K, Norgren L, Blomster JI, Jones WS, Patel MR. Association of Disease Progression With Cardiovascular and Limb Outcomes in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Circ Cardiovasc Interv. 2020 Oct;13(10):e009326.Full Text Link to Item
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Fudim M, Hopley CW, Huang Z, Kavanagh S, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Mahaffey KW, Norgren L, Ostrom C, Patel MR, Jones WS, Hiatt WR. Association of Hypertension and Arterial Blood Pressure on Limb and Cardiovascular Outcomes in Symptomatic Peripheral Artery Disease: The EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006512.Full Text Link to Item
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Ball G, Reblin T, Buchanan J, Hendrickson BA, Lewis E, Schnell PM, Rockhold FW. A Framework for Safety Evaluation Throughout the Product Development Life-Cycle. Ther Innov Regul Sci. 2020 Jul;54(4):821–830.Full Text Open Access Copy Link to Item
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Long CA, Mulder H, Fowkes FGR, Baumgartner I, Berger JS, Katona BG, Mahaffey KW, Norgren L, Blomster JI, Rockhold FW, Hiatt WR, Patel MR, Jones WS, Nehler MR. Incidence and Factors Associated With Major Amputation in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Jul;13(7):e006399.Full Text Link to Item
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Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O’Brien SM, Boden WE, Chaitman BR, Senior R, López-Sendón J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE, Rockhold FW, Broderick S, Ferguson TB, Williams DO, Harrington RA, Stone GW, Rosenberg Y, ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395–1407.Full Text Link to Item
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Rockhold FW, Tenenbaum JD, Richesson R, Marsolo KA, O’Brien EC. Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable. J Am Med Inform Assoc. 2020 Apr 1;27(4):634–638.Full Text Open Access Copy Link to Item
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Sim I, Stebbins M, Bierer BE, Butte AJ, Drazen J, Dzau V, Hernandez AF, Krumholz HM, Lo B, Munos B, Perakslis E, Rockhold F, Ross JS, Terry SF, Yamamoto KR, Zarin DA, Li R. Time for NIH to lead on data sharing. Science. 2020 Mar 20;367(6484):1308–1309.Full Text Link to Item
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Haine A, Kavanagh S, Berger JS, Hess CN, Norgren L, Fowkes FGR, Katona BG, Mahaffey KW, Blomster JI, Patel MR, Jones WS, Rockhold FW, Hiatt WR, Baumgartner I, International Steering Committee and Investigators of the EUCLID Trial. Sex-Specific Risks of Major Cardiovascular and Limb Events in Patients With Symptomatic Peripheral Artery Disease. J Am Coll Cardiol. 2020 Feb 18;75(6):608–617.Full Text Link to Item
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Ward R, Huang Z, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Mahaffey KW, Norgren L, Vemulapalli S, Povsic TJ, Mehta R, Hiatt WR, Patel MR, Jones WS. Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial. Am Heart J. 2020 Feb;220:51–58.Full Text Open Access Copy Link to Item
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Evans SR, Bigelow R, Chuang-Stein C, Ellenberg SS, Gallo P, He W, Jiang Q, Rockhold F. Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job. Ann Intern Med. 2020 Jan 21;172(2):119–125.Full Text Open Access Copy Link to Item
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VanDusen KW, Eleswarpu S, Moretti EW, Devinney MJ, Crabtree DM, Laskowitz DT, Woldorff MG, Roberts KC, Whittle J, Browndyke JN, Cooter M, Rockhold FW, Anakwenze O, Bolognesi MP, Easley ME, Ferrandino MN, Jiranek WA, Berger M, MARBLE Study Investigators. The MARBLE Study Protocol: Modulating ApoE Signaling to Reduce Brain Inflammation, DeLirium, and PostopErative Cognitive Dysfunction. J Alzheimers Dis. 2020;75(4):1319–1328.Full Text Open Access Copy Link to Item
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Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP, Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909–1917.Full Text Open Access Copy Link to Item
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Hopley CW, Kavanagh S, Patel MR, Ostrom C, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Hiatt WR. Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial. Vasc Med. 2019 Oct;24(5):422–430.Full Text Open Access Copy Link to Item
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Kansal A, Huang Z, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FG, Katona B, Mahaffey KW, Norgren L, Hiatt WR, Patel MR, Jones WS. Impact of Procedural Bleeding in Peripheral Artery Disease: An Analysis From EUCLID Trial. Circ Cardiovasc Interv. 2019 Oct;12(10):e008069.Full Text Open Access Copy Link to Item
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Rockhold F, Bromley C, Wagner EK, Buyse M. Open science: The open clinical trials data journey. Clin Trials. 2019 Oct;16(5):539–546.Full Text Open Access Copy Link to Item
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Hess CN, Huang Z, Patel MR, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Held P, Jones WS, Katona B, Mahaffey KW, Norgren L, Rockhold FW, Hiatt WR. Acute Limb Ischemia in Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):556–565.Full Text Open Access Copy Link to Item
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Rockhold FW, Lindblad A, Siegel JP, Molenberghs G. University of Pennsylvania 11th annual conference on statistical issues in clinical trials: Estimands, missing data and sensitivity analysis (morning panel session). Clin Trials. 2019 Aug;16(4):350–362.Full Text Open Access Copy Link to Item
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Kolls BJ, Sapp S, Rockhold FW, Jordan JD, Dombrowski KE, Fowkes FGR, Mahaffey KW, Berger JS, Katona BG, Blomster JI, Norgren L, Abramson BL, Leiva-Pons JL, Prieto JC, Sokurenko G, Hiatt WR, Jones WS, Patel MR. Stroke in Patients With Peripheral Artery Disease. Stroke. 2019 Jun;50(6):1356–1363.Full Text Open Access Copy Link to Item
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Buyse M, Rockhold F. Sharing clinical trial data for research purposes. Innovations & Thérapeutiques En Oncologie. John Libbey Eurotext,; 2019;5(4):208–212.Full Text Open Access Copy
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Olivier CB, Mulder H, Hiatt WR, Jones WS, Fowkes FGR, Rockhold FW, Berger JS, Baumgartner I, Held P, Katona BG, Norgren L, Blomster J, Patel MR, Mahaffey KW. Incidence, Characteristics, and Outcomes of Myocardial Infarction in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Jama Cardiol. 2019 Jan 1;4(1):7–15.Full Text Open Access Copy Link to Item
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Low Wang CC, Blomster JI, Heizer G, Berger JS, Baumgartner I, Fowkes FGR, Held P, Katona BG, Norgren L, Jones WS, Lopes RD, Olin JW, Rockhold FW, Mahaffey KW, Patel MR, Hiatt WR, EUCLID Trial Executive Committee and Investigators. Cardiovascular and Limb Outcomes in Patients With Diabetes and Peripheral Artery Disease: The EUCLID Trial. J Am Coll Cardiol. 2018 Dec 25;72(25):3274–3284.Full Text Open Access Copy Link to Item
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Berger JS, Abramson BL, Lopes RD, Heizer G, Rockhold FW, Baumgartner I, Fowkes FGR, Held P, Katona BG, Norgren L, Jones WS, Millegård M, Blomster J, Reist C, Hiatt WR, Patel MR, Mahaffey KW. Ticagrelor versus clopidogrel in patients with symptomatic peripheral artery disease and prior coronary artery disease: Insights from the EUCLID trial. Vasc Med. 2018 Dec;23(6):523–530.Full Text Open Access Copy Link to Item
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Li R, Scott J, Rockhold F, Hill N, Wood J, Sim I. Moving Data Sharing Forward: The Launch of the Vivli Platform. Nam Perspectives. National Academy of Medicine; 2018 Nov 19;8(11).Full Text Open Access Copy
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Gutierrez JA, Mulder H, Jones WS, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Held P, Katona BG, Mahaffey KW, Norgren L, Hiatt WR, Patel MR. Polyvascular Disease and Risk of Major Adverse Cardiovascular Events in Peripheral Artery Disease: A Secondary Analysis of the EUCLID Trial. Jama Netw Open. 2018 Nov 2;1(7):e185239.Full Text Open Access Copy Link to Item
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Baumgartner I, Norgren L, Fowkes FGR, Mulder H, Patel MR, Berger JS, Jones WS, Rockhold FW, Katona BG, Mahaffey K, Hiatt WR, Executive Committee and Investigators of the EUCLID Trial. Cardiovascular Outcomes After Lower Extremity Endovascular or Surgical Revascularization: The EUCLID Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1563–1572.Full Text Open Access Copy Link to Item
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Pencina MJ, Rockhold FW, D’Agostino RB. Deriving Real-World Insights From Real-World Data: Biostatistics to the Rescue. Ann Intern Med. 2018 Sep 18;169(6):401–402.Full Text Open Access Copy Link to Item
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Peterson ED, Rockhold FW. Finding Means to Fulfill the Societal and Academic Imperative for Open Data Access and Sharing. Jama Cardiol. 2018 Sep 1;3(9):793–794.Full Text Open Access Copy Link to Item
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Rubin JC, Silverstein JC, Friedman CP, Kush RD, Anderson WH, Lichter AS, Humphreys DJ, Brown J, Crawford L, Walker JM, Tannen RL, Berry K, Hamilton Lopez M, Kolodner RM, Marchibroda JM, Rockhold FW. Transforming the future of health together: The Learning Health Systems Consensus Action Plan. Learn Health Syst. 2018 Jul;2(3):e10055.Full Text Open Access Copy Link to Item
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Norgren L, Patel MR, Hiatt WR, Wojdyla DM, Fowkes FGR, Baumgartner I, Mahaffey KW, Berger JS, Jones WS, Katona BG, Held P, Blomster JI, Rockhold FW, Björck M, EUCLID Steering Committee and Investigators. Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial. Eur J Vasc Endovasc Surg. 2018 Jan;55(1):109–117.Full Text Open Access Copy Link to Item
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Rockhold FW. Statistical controversies in clinical research: data access and sharing-can we be more transparent about clinical research? Let's do what's right for patients. Ann Oncol. 2017 Aug 1;28(8):1734–1737.Full Text Open Access Copy Link to Item
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Ohman EM, Roe MT, Steg PG, James SK, Povsic TJ, White J, Rockhold F, Plotnikov A, Mundl H, Strony J, Sun X, Husted S, Tendera M, Montalescot G, Bahit MC, Ardissino D, Bueno H, Claeys MJ, Nicolau JC, Cornel JH, Goto S, Kiss RG, Güray Ü, Park D-W, Bode C, Welsh RC, Gibson CM. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017 May 6;389(10081):1799–1808.Full Text Open Access Copy Link to Item
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Rockhold F. Comments on 'Estimands in clinical trials - broadening the perspective'. Stat Med. 2017 Jan 15;36(1):24–26.Full Text Open Access Copy Link to Item
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Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie M, Moher D. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Japanese Pharmacology and Therapeutics. 2017 Jan 1;45(12):1895–1904.
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Rockhold F, Nisen P, Freeman A. Data Sharing at a Crossroads. N Engl J Med. 2016 Sep 22;375(12):1115–1117.Full Text Open Access Copy Link to Item
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Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krle A-Jerić K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015 Dec;38(6):506–514.Link to Item
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Berlin JA, Morris S, Rockhold F, Askie L, Ghersi D, Waldstreicher J. Bumps and bridges on the road to responsible sharing of clinical trial data. Clin Trials. 2014 Feb;11(1):7–12.Full Text Open Access Copy Link to Item
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Nisen P, Rockhold F. Access to patient-level data from GlaxoSmithKline clinical trials. N Engl J Med. 2013 Aug 1;369(5):475–478.Full Text Open Access Copy Link to Item
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Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200–207.Full Text Open Access Copy Link to Item
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Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. Spirit 2013 statement: Defining standard protocol items for clinical trials. Chinese Journal of Evidence Based Medicine. 2013 Jan 1;13(12):1501–1507.Full Text
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Rockhold FW, Enas GG. 10 Years with ICH E10: Choice of Control Groups. Pharm Stat. 2011;10(5):407–409.Full Text Open Access Copy Link to Item
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Chuang-Stein C, Bain R, Branson M, Burton C, Hoseyni C, Rockhold F, Ruberg S, Zhang J. Statisticians in the Pharmaceutical Industry: The 21st Century. Statistics in Biopharmaceutical Research. Informa UK Limited; 2010 May;2(2):145–152.Full Text
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Strahlman E, Rockhold F, Freeman A. Public disclosure of clinical research. Lancet. 2009 Apr 18;373(9672):1319–1320.Full Text Link to Item
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Rockhold FW, Freeman AJ, Metz CA. Public disclosure of clinical trial results: A necessary step on the path to transparency and trust. Pharmaceutical Medicine. 2009 Jan 1;23(3):131–137.Full Text
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Ghersi D, Clarke M, Berlin J, Gülmezoglu A, Kush R, Lumbiganon P, Moher D, Rockhold F, Sim I, Wager E. Reporting the findings of clinical trials: a discussion paper. Bull World Health Organ. 2008 Jun;86(6):492–493.Full Text Link to Item
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Kush RD, Helton E, Rockhold FW, Hardison CD. Electronic health records, medical research, and the Tower of Babel. N Engl J Med. 2008 Apr 17;358(16):1738–1740.Full Text Open Access Copy Link to Item
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Hughes S. European regulatory agencies should employ full time statisticians. Bmj. 2008 Feb 2;336(7638):250.Full Text Link to Item
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Metz CA, Rockhold F, Freeman A. The GSK Clinical Study Results Database: Site Utilization Metrics for a Large Public Database. Therapeutic Innovation &Amp; Regulatory Science. 2008 Jan 1;42(3):247–252.Full Text
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Rockhold FW, Ruberg SJ. ICH-E9 reflections and considerations. Pharm Stat. 2008;7(4):233–235.Full Text Link to Item
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Krall RL, Rockhold F. Reasons for optimism not disillusionment. J R Soc Med. 2006 Sep;99(9):435.Full Text Link to Item
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Rockhold FW, Krall RL. Trial summaries on results databases and journal publication. Lancet. 2006 May 20;367(9523):1635–1636.Full Text Link to Item
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Krall RL, Rockhold F. To the editor [11]. New England Journal of Medicine. 2006 Mar 30;354(13):1427.
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Rockhold FW, Krall RL. Clinical trials registration. Plos Med. 2006 Mar;3(3):e157.Full Text Open Access Copy Link to Item
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Krall RL, Rockhold F. Clinical trials report card. New England Journal of Medicine. 2006;354(13):1427–1427.Link to Item
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Rockhold FW. Requiring 'independent' statistical analyses for industry sponsored trials? Pharm Stat. 2006;5(1):5–6.Full Text Link to Item
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Society for Clinical Trials Board of Directors. The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients. Clin Trials. 2006;3(2):154–157.Full Text Link to Item
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Rockhold F. Multicentre trials: Foreword. Statistical Methods in Medical Research. 2005 Jun 1;14(3):201.Full Text
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Rockhold F. Multicentre trials. Statistical Methods in Medical Research. SAGE Publications; 2005 Jun;14(3):201–201.Full Text
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Krall R, Rockhold F. More on compulsory registration of clinical trials: GSK has created useful register. Bmj. 2005 Feb 26;330(7489):479–480.Full Text Link to Item
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Krall R, Rockhold F. Trial registration: ignored to irresistible. Jama. 2005 Jan 12;293(2):158.Full Text Link to Item
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Rockhold F. The Society for Clinical Trials supports United States legislation mandating trials registration. Clin Trials. 2005;2(2):193.Full Text Link to Item
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DeMets D, Califf R, Dixon D, Ellenberg S, Fleming T, Held P, Julian D, Kaplan R, Levine R, Neaton J, Packer M, Pocock S, Rockhold F, Seto B, Siegel J, Snapinn S, Stump D, Temple R, Whitley R. Issues in regulatory guidelines for data monitoring committees. Clin Trials. 2004;1(2):162–169.Full Text Open Access Copy Link to Item
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DeMets DL, Fleming TR, Rockhold F, Massie B, Merchant T, Meisel A, Mishkin B, Wittes J, Stump D, Califf R. Liability issues for data monitoring committee members. Clin Trials. 2004;1(6):525–531.Full Text Open Access Copy Link to Item
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Rockhold FW. Industry perspectives on ICH guidelines. Stat Med. 2002 Oct 15;21(19):2949–2957.Full Text Link to Item
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Rockhold F, Metz A, Traber P. Response from GlaxoSmithKline. British Journal of Psychiatry. Royal College of Psychiatrists; 2002 Jun;180(06):548–548.Full Text
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Dragalin V, Fedorov V, Jones B, Rockhold F. Estimation of the combined response to treatment in multicenter trials. J Biopharm Stat. 2001 Nov;11(4):275–295.Link to Item
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Lewis J, Louv W, Rockhold F, Sato T. The impact of the international guideline entitled Statistical Principles for Clinical Trials (ICH E9). Stat Med. 2001 Sep 15;20(17–18):2549–2560.Full Text Link to Item
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Rockhold FW. Strategic use of statistical thinking in drug development. Stat Med. 2000 Dec 15;19(23):3211–3217.Full Text Open Access Copy Link to Item
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Knatterud GL, Rockhold FW, George SL, Barton FB, Davis CE, Fairweather WR, Honohan T, Mowery R, O’Neill R. Guidelines for quality assurance in multicenter trials: a position paper. Control Clin Trials. 1998 Oct;19(5):477–493.Full Text Link to Item
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Rockhold FW, Goldberg MR. An approach to the assessment of therapeutic drug interactions with fixed combination drug products. J Biopharm Stat. 1996 Jul;6(3):231–240.Full Text Link to Item
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Rockhold FW, Enas GG. Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. Stat Med. 1993 Mar;12(5–6):471–479.Full Text Open Access Copy Link to Item
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MEIER, HARRINGTON, ROCKHOLD F, WILLIAMS G, BROWN, HERSON J, BUYSE M, DEYKIN D, YUSUF. DATA MONITORING AND INTERIM ANALYSES IN THE PHARMACEUTICAL-INDUSTRY - ETHICAL AND LOGISTICAL CONSIDERATIONS - MONITORING OF CLINICAL-TRIALS AND INTERIM ANALYSES FROM A DRUG SPONSORS POINT-OF-VIEW - DISCUSSION. Statistics in Medicine. 1993;12(5–6):493–495.Link to Item
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Martin LF, Booth FV, Karlstadt RG, Silverstein JH, Jacobs DM, Hampsey J, Bowman SC, D’Ambrosio CA, Rockhold FW. Continuous intravenous cimetidine decreases stress-related upper gastrointestinal hemorrhage without promoting pneumonia. Crit Care Med. 1993 Jan;21(1):19–30.Full Text Open Access Copy Link to Item
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Karlstadt RG, Iberti TJ, Silverstein J, Lindenberg L, Rright-Asare P, Rockhold F, Young MD. Comparison of Cimetidine and Placebo for the Prophylaxis of Upper Gastrointestinal Bleeding Due to Stress-related Gastric Mucosal Damage in the Intensive Care Unit. Journal of Intensive Care Medicine. 1990 Jan 1;5(1):26–32.Full Text
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Palmer RH, Frank WO, Rockhold FW, Wetherington JD, Young MD. Cimetidine 800 mg twice daily for healing erosions and ulcers in gastroesophageal reflux disease. J Clin Gastroenterol. 1990;12 Suppl 2:S29–S34.Full Text Link to Item
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Frank WO, Young MD, Palmer R, Rockhold F, Karlstadt R, Mounce W, O’Connell S. Acute treatment of benign gastric ulcer with once-daily bedtime dosing of cimetidine compared with placebo. Aliment Pharmacol Ther. 1989 Dec;3(6):573–584.Full Text Link to Item
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Rockhold FW, Goldberg MR, Thompson WL. Beneficial effects of pinacidil on blood lipids: comparisons with prazosin and placebo in patients with hypertension. Pinacidil-Prazosin and Pinacidil-Placebo Research Groups, Lilly Research Laboratories. J Lab Clin Med. 1989 Dec;114(6):646–654.Link to Item
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Frank WO, Wallin BA, Berkowitz JM, Kimmey MB, Palmer RH, Rockhold F, Young MD. Reduction of indomethacin induced gastroduodenal mucosal injury and gastrointestinal symptoms with cimetidine in normal subjects. J Rheumatol. 1989 Sep;16(9):1249–1252.Link to Item
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Frank W, Karlstadt R, Rockhold F, Palmer R, Malone M, Young M. Comparison between continuous and intermittent infusion regimens of cimetidine in ulcer patients. Clin Pharmacol Ther. 1989 Aug;46(2):234–239.Full Text Link to Item
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Goldberg MR, Rockhold FW, Offen WW, Dornseif BE. Dose-effect and concentration-effect relationships of pinacidil and hydrochlorothiazide in hypertension. Clin Pharmacol Ther. 1989 Aug;46(2):208–218.Full Text Link to Item
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Enas GG, Dornseif BE, Sampson CB, Rockhold FW, Wuu J. Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry. Control Clin Trials. 1989 Mar;10(1):57–70.Full Text Link to Item
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Frank W, Karlstadt R, Rockhold F, Palmer R, Malone M, Young M. Erratum: Comparison between continuous and intermittent infusion regimens of cimetidine in ulcer patients (Clin Pharmacol Ther 1989; 46: 234-9). Clinical Pharmacology and Therapeutics. 1989 Jan 1;46(5):500.
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Frank WO, Young M, Palmer RH, Karlstadt R, Rockhold F, Mounce W. Once-daily bedtime dosing regimen of cimetidine in the treatment of gastric ulcer. Clin Ther. 1989;11(5):595–603.Link to Item
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Goldberg MR, Rockhold FW, Thompson WL, DeSante KA. Clinical pharmacokinetics of pinacidil, a potassium channel opener, in hypertension. J Clin Pharmacol. 1989 Jan;29(1):33–40.Full Text Link to Item
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Maroko PR, McDevitt JT, Fox MJ, Silber SA, Young MD, Beg M, Rockhold FW, Free SM, Herron JR, Gray JM. Antihypertensive effectiveness of very low doses of hydrochlorothiazide: results of the PHICOG Trial. Clin Ther. 1989;11(1):94–119.Link to Item
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Young MD, Frank WO, Karlstadt RG, O’Connell S, Palmer RH, Rockhold FW, Kogut DG, Loiudice TA, Orchard JL, Stone RC. Efficacy of once-daily cimetidine in preventing recurrence of duodenal ulcer. Clin Ther. 1989;11(4):529–538.Link to Item
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Young MD, Frank WO, Karlstadt RG, O’Connell S, Palmer RH, Rockhold FW, Kogut DG, Loiudice TA, Orchard JL, Stone RC. The efficacy of cimetidine in the treatment of "resistant" duodenal ulcers. Clin Ther. 1989;11(4):521–528.Link to Item
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Goldberg MR, Sushak CS, Rockhold FW, Thompson WL. Vasodilator monotherapy in the treatment of hypertension: comparative efficacy and safety of pinacidil, a potassium channel opener, and prazosin. Clin Pharmacol Ther. 1988 Jul;44(1):78–92.Full Text Link to Item
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Goldberg MR, Offen WW, Rockhold FW. Factorial design. An approach to the assessment of therapeutic drug interactions in clinical trials. Journal of Clinical Research and Drug Development. 1988 Jan 1;2(4):215–225.
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Ridolfo AS, Ashbrook EM, Schmid GE, Vogel JA, Rockhold FW, Offen WW. A double-blind study comparing benoxaprofen, aspirin, and benoxaprofen plus aspirin in patients with rheumatoid arthritis. Eur J Rheumatol Inflamm. 1982;5(2):239–245.Link to Item
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Ridolfo AS, Carmichael RH, DeSante KA, Bergstrom RF, Rockhold FW, Nash JF, Fineberg SE. Clinical pharmacology of benoxaprofen. Eur J Rheumatol Inflamm. 1982;5(2):98–112.Link to Item
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Rockhold FW, Kilpatrick SJ. Methods of Discrimination Among Stochastic Models of the Negative Binomial Distribution with an Application to Medical Statistics. Biometrical Journal. Wiley; 1981;23(7):681–692.Full Text Open Access Copy
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Steinberg MI, Sullivan ME, Wiest SA, Rockhold FW, Molloy BB. Cellular electrophysiology of clofilium, a new antifibrillatory agent, in normal and ischemic canine Purkinje fibers. J Cardiovasc Pharmacol. 1981;3(4):881–895.Full Text Open Access Copy Link to Item
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Ridolfo AS, Crabtree RE, Johnson DW, Rockhold FW. Gastrointestinal microbleeding: comparisons between benoxaprofen and other nonsteroidal antiinflammatory agents. J Rheumatol Suppl. 1980;6:36–47.Link to Item
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Boyle RM, Rockhold FW. An analysis of returning patients in family practice. J Fam Pract. 1979 May;8(5):1029–1036.Link to Item
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Rockhold FW, Boyle RM. Family practice in Virginia: a comparative analysis of two years' data. J Fam Pract. 1978 Apr;6(4):793–797.Link to Item
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Boyle RM, Rockhold FW, Mitchell GS, VanHorn S. The Age/Sex Register: estimation of the practice population. J Fam Pract. 1977 Dec;5(6):999–1003.Link to Item
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Book Sections
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Rockhold F, Segreti T. Secondary Efficacy end Points. Methods and Applications of Statistics in Clinical Trials. 2014. p. 731–739.Full Text
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Rockhold F, Enas GG. Practical Approaches to the Design and Conduct of Interim Analyses. Biopharmaceutical Sequential Statistical Applications. 1992.
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Rockhold F, Kilpatrick SJ. Estimation of the Population at Risk in General Practice Using Truncated Information from the Negative Binomial. Primary Care Research. 1985. p. 65–81.
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Rockhold F, Dragalin V, Fedorov V, Jones B. Estimation of the Combined Response to Treatment in Multicenter Trials. BDS Technical Report 2000-06.
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Rockhold F, Goldstein B. Pragmatic Randomized Trials Using Claims or Electronic Health Record Data. In: friedman L, geller N, editors. Principles and Practice of Clinical Trials.Full Text Link to Item
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Conference Papers
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Sidhu MS, Alexander KP, Huang Z, O’Brien SM, Chaitman BR, Stone GW, Newman JD, Boden WE, Maggioni AP, Steg PG, Ferguson TB, Demkow M, Peteiro J, Wander GS, Phaneuf DC, De Belder MA, Doerr R, Alexanderson-Rosas E, Polanczyk CA, Henriksen PA, Conway DSG, Miro V, Sharir T, Lopes RD, Min JK, Berman DS, Rockhold FW, Balter S, Borrego D, Rosenberg YD, Bangalore S, Reynolds HR, Hochman JS, Maron DJ, ISCHEMIA Research Group. Causes of cardiovascular and noncardiovascular death in the ISCHEMIA trial. Am Heart J. 2022. p. 72–83.Full Text Link to Item
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Cardet JC, Pace WD, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Hernandez PA, Kruse J, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Coyne-Beasley T, Hammer GM, Kaplan BM, Madison S, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, Mckee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang K, Pinto-Plata V, Stranges PM, Hurley LH, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy KV, Pasarica M, Candelario RAC, Tapp H, Baydur A, Yawn BP, Israel E. An Add-on Reliever-Triggered Inhaled Corticosteroid Strategy Reduces Severe Asthma Exacerbations in a Real-World Study of African American/Black and Hispanic/Latinx Patients with Asthma. American Journal of Respiratory and Critical Care Medicine. 2022.Link to Item
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Pracon R, Spertus JA, Broderick S, Bangalore S, Rockhold FW, Ruzyllo W, Demchenko E, Mavromatis K, Stone GW, Mancini GBJ, Boden WE, Newman JD, Reynolds HR, Hochman JS, Maron DM. Factors associated with early catheterization in patients randomized to the conservative strategy in the ISCHEMIA Trial. European Heart Journal. 2022. p. 1215–1215.Link to Item
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VanDusen KW, Eleswarpu S, Moretti E, Devinney M, Roberts K, Cooter M, Laskowitz DT, Rockhold FW, Berger M. The MARBLE Study: Modulating ApoE signaling to Reduce Brain inflammation, deLirium, and postopErative Cognitive Dysfunction. Anesthesia and Analgesia. 2020. p. 432–433.Link to Item
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Povsic TJ, Ohman EM, Roe MT, White J, Rockhold FW, Montalescot G, Cornel JH, Nicolau JC, Steg PG, James S, Bode C, Welsh RC, Plotnikov AN, Mundl H, Gibson CM. P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes. Jama Cardiol. 2019. p. 680–684.Full Text Open Access Copy Link to Item
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Hopley CW, Kavanagh S, Patel M, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Jones WS, Katona BG, Mahaffey KW, Norgren L, Held P, Rockhold FW, Hiatt WR. Moderate to severe renal insufficiency and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: the EUCLID trial. European Heart Journal. OXFORD UNIV PRESS; 2018. p. 836–837.Link to Item
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Jones WS, Ward R, Huang Z, Rockhold F, Baumgartner I, Berger J, Blomster J, Fowkes FG, Katona B, Mahaffey K, Norgren L, Mehta R, Povsic T, Vemulapalli S, Hiatt W, Patel MR. MAJOR BLEEDING IN PATIENTS WITH PERIPHERAL ARTERY DISEASE: INSIGHTS FROM THE EUCLID TRIAL. Journal of the American College of Cardiology. Elsevier BV; 2018. p. A2027–A2027.Full Text
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Patel MR, Heizer G, Mahaffey K, Fowkes FG, Berger J, Baumgartner I, Rockhold F, Held P, Katona B, Norgren L, Jones W, Blomster J, Hiatt W. CYP2C19 STATUS AND OUTCOMES IN THE EUCLID TRIAL. Journal of the American College of Cardiology. Elsevier BV; 2018. p. A2087–A2087.Full Text
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Gutierrez A, Mulder H, Jones S, Rockhold F, Berger J, Blomster J, Hiatt W, Katona B, Norgren L, Patel M. TCT-92 Polyvascular Disease and Risk of Major Cardiovascular Events in Peripheral Artery Disease—Insights from EUCLID. Journal of the American College of Cardiology. Elsevier BV; 2017. p. B40–B40.Full Text
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Olivier C, Hiatt W, Wojdyla D, Jones S, Rockhold F, Berger J, Katona B, Norgren L, Blomster J, Patel M. TCT-339 Types of Myocardial Infarction in Patients with Peripheral Artery Disease: Insights From EUCLID. Journal of the American College of Cardiology. Elsevier BV; 2017. p. B139–B139.Full Text
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Blomster J, Wang CL, Heizer G, Berger JS, Baumgartner I, Fowkes FGR, Held P, Katona BG, Norgren L, Jones WS, Rockhold FW, Mahaffey KW, Patel MR, Hiatt WR. Diabetes and cardiovascular risk in patients with symptomatic peripheral artery disease. European Heart Journal. OXFORD UNIV PRESS; 2017. p. 1080–1080.Link to Item
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Kolls B, Sapp S, Hiatt WR, Norgren L, Berger JS, Rockhold FW, Katona BG, Blomster J, Jones WS, Patel MR, Mahaffey KW. The occurrence of stroke and TIA in patients with peripheral artery disease and the effect of ticagrelor versus clopidogrel in EUCLID. European Heart Journal. OXFORD UNIV PRESS; 2017. p. 1081–1082.Link to Item
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Baumgartner I, Mulder H, Rockhold F, Berger JS, Blomster J, Fowkes FG, Held P, Jones WS, Katona B, Mahaffey KW, Hiatt WR, Patel MR, Norgren L. Post-Randomization Lower Extremity Revascularization in the EUCLID Trial. Circulation. 2017.Link to Item
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Walton M, Simon R, Rockhold F, DuMouchel W, Koch G, O’Neill R. Panel discussion of case study 3. Clinical Trials. 2005. p. 352–358.Full Text
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Rockhold FW, Enas G, Williams GW, Meier P, Harrington D, Brown, Meinert C, Herson J, Buyse M, Deykin D, Yusuf S. Discussion: Frank W Rockhold and G Enas, data monitoring and interim analyses in the pharmaceutical industry: Ethical and logistical considerations: George W Williams et al, monitoring of clinical trials and interim analyses from a drug sponsor's point of view. Statistics in Medicine. 1993. p. 493–495.
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KARLSTADT RG, DAMBROSIO CA, PALMER RH, WIKLER MA, ROCKHOLD FW, FOX MJ. NO INCREASED RISK OF NOSOCOMIAL PNEUMONIA WITH CIMETIDINE - EXPERIENCE IN A MULTICENTER, PLACEBO-CONTROLLED ICU STUDY. Clinical Research. 1990. p. A273–A273.Link to Item
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YOUNG MD, FRANK W, PALMER R, ROCKHOLD F. EFFECTIVENESS OF CIMETIDINE MAINTENANCE THERAPY FOLLOWING TREATMENT WITH RANITIDINE. Clinical Research. 1989. p. A114–A114.Link to Item
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DIES F, ROCKHOLD FW. COMPARISON OF INDECAINIDE WITH PROCAINAMIDE IN SUSTAINED VENTRICULAR TACHYARRHYTHMIAS. Clinical Research. 1987. p. A875–A875.Link to Item
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GOLDBERG MR, ROCKHOLD FW. INFLUENCE OF AGE AND RENAL-FUNCTION ON THE DISPOSITION OF PINACIDIL. Clinical Research. 1987. p. A375–A375.Link to Item
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GOLDBERG MR, ROCKHOLD FW. T-WAVE CHANGES DURING THERAPY WITH PINACIDIL - A POTASSIUM CHANNEL ACTIVATOR. Clinical Research. 1987. p. A442–A442.Link to Item
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GOLDBERG MR, ROCKHOLD FW. FACTORIAL-DESIGNS IN THE ASSESSMENT OF THERAPEUTIC DRUG-INTERACTION IN HYPERTENSION. Clinical Research. 1987. p. A882–A882.Link to Item
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GOLDBERG MJ, SPECTOR R, MILLER G. PHENOBARBITAL IMPROVES SURVIVAL IN THEOPHYLLINE INTOXICATION IN RABBITS. Clinical Research. 1986. p. A399–A399.Link to Item
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GOLDBERG MR, ROCKHOLD FW, SUSHAK CS. VASODILATOR MONOTHERAPY IN THE TREATMENT OF ESSENTIAL-HYPERTENSION. Clinical Research. 1986. p. A479–A479.Link to Item
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GOLDBERG MR, ROCKHOLD FW. BENEFICIAL-EFFECTS OF PINACIDIL ON PLASMA-LIPIDS. Journal of Hypertension. 1986. p. S575–S575.Link to Item
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GOLDBERG MR, SUSHAK CS, ROCKHOLD FW, THOMPSON WL. PINACIDIL VS PRAZOSIN IN THE TREATMENT OF HYPERTENSION. Clinical Research. 1986. p. A399–A399.Link to Item
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ROCKHOLD FW, MATTLER MK, HAVRON EC, PHILLIPS NB. USE OF CUMULATIVE WITHDRAWAL RATES IN THE EVALUATION OF SAFETY AND EFFICACY IN A LONG-TERM CONTROLLED CLINICAL-TRIAL. Controlled Clinical Trials. 1983. p. 156–156.Link to Item
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SCHIESS JR, ROCKHOLD FW. DISTRIBUTION OF THE NUMBER OF ZERO CROSSINGS OF A GAUSSIAN STOCHASTIC-PROCESS - A SIMULATION STUDY. Biometrics. 1981. p. 190–190.Link to Item
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- Teaching & Mentoring
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Advising & Mentoring
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Biostatistics and Bioinformatics Department Mentoring Group
Biostatistics Mentoring Group DCRI
Serve on 5 Faculty Mentoring Committees
Available to mentor:
- Faculty
- Fellow
- PhD
- Post-Doc
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Biostatistics and Bioinformatics Department Mentoring Group
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Teaching Activities
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Data Monitoring in the CRTP program
Data Monitoring in the Learning Laboratory
UCSF FDA Training Program for new Drug and Vaccine Reviewers.
Bio 706
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Data Monitoring in the CRTP program
- Scholarly, Clinical, & Service Activities
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Outreach & Engaged Scholarship
- Peer Review. BMJ. 2020 - 2022 2020 - 2022
- Peer Reviewer. American Statistician. 2018 - 2020 2018 - 2020
- Peer Reviewer. Circulation. 2017 - 2020 2017 - 2020
- Peer Reviewer. JAMA. 2017 - 2022 2017 - 2022
- Peer Reviewer. PLOS One. 2017 - 2022 2017 - 2022
- Peer Reviewer. Trials. 2017 - 2020 2017 - 2020
- Peer Reviewer. JAMA Cardiology. 2016 - 2022 2016 - 2022
- Peer Reviewer. New England Journal of Medicine. 2016 - 2022 2016 - 2022
- Peer Reviewer. Pharmaceutical Statistics. 2016 - 2022 2016 - 2022
- Peer Reviewer. Pharmacoepidemiology and Drug Safety. 2016 - 2020 2016 - 2020
- Peer Reviewer. Statistics in Biopharmceutical Research. 2016 - 2022 2016 - 2022
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Service to the Profession
- Advisor. Drug Safety Research Unit. Oxford University. April 2019 2019
- Advisor. Proactive Safety Surveillance. Multi-Regional Clinical Trials Center. November 2018 2018
- Advisor. Clinical Trials Diversity. Multi-Regional Clinical Trials Center. June 2018 2018
- Member RWD Working group. American Statistical Association. 2018 2018
- Advisor. Technical Anonymization Group. European Medicines Agency. 2017 - 2021 2017 - 2021
- Member program committee. FDA-ASA Statistics Workshop. American Statistical Association. 2017 - 2019 2017 - 2019
- Member program committee. FDA-DIA Statistics Forum. Drug Information Association. 2017 - 2021 2017 - 2021
- Member. Trial of the Year Committee. Society for Clinical Trials. 2017 2017
- Member Safety Methods Workgroup. American Statistical Association. 2016 - 2019 2016 - 2019
- Senior Advisor. Advisory Board. Vivli. June 2015 2015
- Chairman. Board of Directors. Frontier Science and Technology Foundation. 2015 - 2022 2015 - 2022
- Editorial Advisory Board of Pharmaceutical Statistics. Wiley. 2015 2015
- Advisor. Clinical Trial Advisory Panel. Patient Center Outcomes Research Institute (PCORI). 2014 - 2017 2014 - 2017
- Member. Board of Regents Clinical Trial Working Group. National Library of Medicine. 2007 - 2010 2007 - 2010
- Member. Scientific Advisory Group for the International Clinical Trials Registry Project. World Health Organization. 2005 - 2008 2005 - 2008
- Chair. Board of Directors. Clinical Data Interoperability Standards Consortium (CDISC). 2004 - 2013 2004 - 2013
- President. Society for Clinical Trials. 1995 - 1998 1995 - 1998
- Expert: E1, E9, E10. International Conference on Harmonization. ICH. 1992 - 2000 1992 - 2000
- Director. Board of Directors. Society for Clinical Trials. 1989 - 1993 1989 - 1993
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Service to Duke
- Biostatistics and Bioinformatics. Committee on Culture, Diversity and Inclusion. October 2019 2019
- Duke University School of Medicine. Research Misconduct. September 2019 2019
- Advisor. Duke-Margolis RWEndpoints Workgroup. Duke-Margolis. July 7, 2019 - February 2020 2019 - 2020
- Biostatistics and Bioinformatics. Academic Review Committee. July 2019 2019
- Presenter. Duke Open Science Roundtable. Duke University School of Medicine. February 27, 2019 - February 27, 2019 2019
- Expert Advisor. "Evaluating the Pressor Effects of Drugs & Ambulatory Blood Pressure Monitoring Studies". Duke-Margolis. February 4, 2019 - February 4, 2019 2019
- Biostatistics and Bioinformatics. PhD Admissions Committee. November 2018 2018
- Medical School. Chair Search for Biostatistics and Bioinformatics. August 2018 - March 2019 2018 - 2019
- Duke Clinical Research Institute. Strategic Planning Group. 2018 - 2019 2018 - 2019
- Expert Advisor. Advancing Structured Benefit-Risk Assessment in FDA Review. Duke-Margolis. October 4, 2017 - October 4, 2017 2017
- Biostatistics and Bioinformatics. Duke Industry Statistics Symposium. 2016 - 2020 2016 - 2020
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Academic & Administrative Activities
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Serve and/or Chair on >12 Data Monitoring Committees
Have served in the past on >50 data monitoring committees
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Serve and/or Chair on >12 Data Monitoring Committees
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