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Publication Venue For
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Bringing data monitoring committee charters into the sunlight..
17407745231169499.
2023
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Commentary on Harun et al.: The use of historical controls in randomized clinical trials..
17407745231158913.
2023
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Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience..
20:31-35.
2023
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Ethics challenges in sharing data from pragmatic clinical trials..
19:681-689.
2022
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Fitness of real-world data for clinical trial data collection: Results and lessons from a HARMONY Outcomes ancillary study..
19:655-664.
2022
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Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges..
19:561-572.
2022
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The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials..
19:277-284.
2022
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Constructing and evaluating a validity argument for a performance outcome measure for clinical trials: An example using the Multi-luminance Mobility Test..
19:184-193.
2022
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Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)..
19:52-61.
2022
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Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations..
18:699-705.
2021
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Covariate adjustment in subgroup analyses of randomized clinical trials: A propensity score approach..
18:570-581.
2021
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Intra-cluster correlations from the CLustered OUtcome Dataset bank to inform the design of longitudinal cluster trials..
18:529-540.
2021
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Clinician engagement in the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial..
18:449-456.
2021
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Strategies for research participant engagement: A synthetic review and conceptual framework..
18:457-465.
2021
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Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study..
18:343-350.
2021
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Adverse event load, onset, and maximum grade: A novel method of reporting adverse events in cancer clinical trials..
18:51-60.
2021
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Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)..
18:104-114.
2021
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Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods..
18:3-16.
2021
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Five analytic challenges in working with electronic health records data to support clinical trials with some solutions..
17:370-376.
2020
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Leveraging electronic health record data for pragmatic randomized trials..
17:368-369.
2020
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Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial..
17:360-367.
2020
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University of Pennsylvania 12th annual conference on statistical issues in clinical trials: Electronic health records in randomized clinical trials-challenges and opportunities (morning panel session)..
17:405-413.
2020
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Role of health plan administrative claims data in participant recruitment for pragmatic clinical trials: An Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) example..
17:212-222.
2020
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Public views regarding the responsibility of patients, clinicians, and institutions to participate in research in the United States..
16:574-579.
2019
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Open science: The open clinical trials data journey..
16:539-546.
2019
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Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study..
16:481-489.
2019
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Addressing guideline and policy changes during pragmatic clinical trials..
16:431-437.
2019
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Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health..
16:419-430.
2019
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University of Pennsylvania 11th annual conference on statistical issues in clinical trials: Estimands, missing data and sensitivity analysis (morning panel session)..
16:350-362.
2019
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Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study..
16:263-272.
2019
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Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program..
16:253-262.
2019
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Establishing an electronic health record-supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience..
16:306-315.
2019
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Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance..
16:290-296.
2019
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Developing a risk-based composite neurologic outcome for a trial of hydroxyurea in young children with sickle cell disease..
16:20-31.
2019
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FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial..
16:90-97.
2019
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Bayesian comparative effectiveness study of four consensus treatment plans for initial management of systemic juvenile idiopathic arthritis: FiRst-Line Options for Systemic juvenile idiopathic arthritis Treatment (FROST)..
15:268-277.
2018
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Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov..
15:87-94.
2018
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The Clinical Trials Transformation Initiative: Looking back, looking forward..
15:3-4.
2018
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The Clinical Trials Transformation Initiative: Methodology supporting the mission..
15:13-18.
2018
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Design of a randomized clinical trial of a colorectal cancer screening decision aid to promote appropriate screening in community-dwelling older adults..
14:648-658.
2017
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Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative..
14:342-348.
2017
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Evaluation of different recall periods for the US National Cancer Institute's PRO-CTCAE..
14:255-263.
2017
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Data monitoring committees: Promoting best practices to address emerging challenges..
14:115-123.
2017
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Rejoinder..
14:126-127.
2017
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Comparison of futility monitoring guidelines using completed phase III oncology trials..
14:48-58.
2017
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Maximizing value and minimizing barriers: Patient-centered community consultation for research in emergency settings..
14:88-93.
2017
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The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight-loss maintenance..
14:29-36.
2017
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Response..
13:568-569.
2016
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Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core..
13:504-512.
2016
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University of Pennsylvania eighth annual conference on statistical issues in clinical trials: Pragmatic clinical trials (afternoon panel)..
13:527-536.
2016
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Recruitment for a hospital-based pragmatic clinical trial using volunteer nurses and students..
13:425-433.
2016
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Alignment of site versus adjudication committee-based diagnosis with patient outcomes: Insights from the Providing Rapid Out of Hospital Acute Cardiovascular Treatment 3 trial..
13:140-148.
2016
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Commentary on Sertkaya et al. and Larson et al..
13:137-139.
2016
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A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response..
13:22-30.
2016
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Ebola clinical trials: Five lessons learned and a way forward..
13:83-86.
2016
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Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial..
12:634-645.
2015
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Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials..
12:476-484.
2015
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Harms, benefits, and the nature of interventions in pragmatic clinical trials..
12:467-475.
2015
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The Food and Drug Administration and pragmatic clinical trials of marketed medical products..
12:511-519.
2015
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Use of altered informed consent in pragmatic clinical research..
12:494-502.
2015
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A multi-site randomized clinical trial to reduce suicidal ideation in suicidal adult outpatients with Major Depressive Disorder: Development of a methodology to enhance safety..
12:189-198.
2015
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Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems..
12:276-286.
2015
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Ethical considerations in design of a study to evaluate a US Food and Drug Administration-approved indication: antivenom versus placebo for copperhead envenomation..
11:560-564.
2014
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Organizational and physician factors associated with patient enrollment in cancer clinical trials..
11:565-575.
2014
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Attitudes toward clinical trials among patients with sickle cell disease..
11:275-283.
2014
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Bumps and bridges on the road to responsible sharing of clinical trial data..
11:7-12.
2014
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Participants' perspectives on safety monitoring in clinical trials..
10:552-559.
2013
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Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature..
10:560-567.
2013
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IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies..
10:319-331.
2013
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The national drug abuse treatment clinical trials network data share project: website design, usage, challenges, and future directions..
10:977-986.
2013
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Panel discussion 1..
9:696-704.
2012
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A surveillance system for monitoring, public reporting, and improving minority access to cancer clinical trials..
9:426-435.
2012
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Analysis of combined data from heterogeneous study designs: an applied example from the patient navigation research program..
9:176-187.
2012
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Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials..
8:591-600.
2011
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Monitoring the quality of conduct of clinical trials: a survey of current practices..
8:342-349.
2011
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Development of adherence metrics for caloric restriction interventions..
8:155-164.
2011
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Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials..
7:312-321.
2010
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Designing and implementing sample and data collection for an international genetics study: the Type 1 Diabetes Genetics Consortium (T1DGC)..
7:S5-S32.
2010