Mark B McClellan | Scholars@Duke

Mark B McClellan
Professor of the Practice of Business Administration

Mark McClellan, MD, PhD, is the Robert J. Margolis Professor of Business, Medicine, and Policy, and Director of the Duke-Margolis Center for Health Policy at Duke University with offices at Duke and in Washington DC. The new Center will support and conduct research, evaluation, implementation, and educational activities to improve health policy and health, through collaboration across Duke University and Health System, and through partnerships between the public and private sectors. It integrates the social, clinical, and analytical sciences to integrate technical expertise and practical capabilities to develop and apply policy solutions that improve health and the value of health care locally, nationally, and worldwide.

Current Appointments & Affiliations

Professor of the Practice of Business Administration, Fuqua School of Business, Duke University 2016
Professor of the Practice in the Sanford School of Public Policy, Sanford School of Public Policy, Duke University 2016

Contact Information

100 Fuqua Drive, Box 90120, Durham, NC 27708
mark.mcclellan@duke.edu (919) 660-7963
Fuqua Faculty Profile

Background
Education, Training, & Certifications
- Ph.D., Massachusetts Institute of Technology 1993
- M.D., Harvard Medical School 1992
- M.P.A., Harvard University 1991
- B.A., University of Texas at Austin 1985
Recognition
In the News
- FEB 9, 2017
  
  Duke-Margolis Center For Health Policy Launches
- NOV 10, 2016
  
  The 2016 Elections' Implications for Health Care Policy
- OCT 23, 2016 NPR
  
  Dr. Mark McClellan comments: Small savings for drugs made to mimic biotech blockbusters
- SEP 6, 2016 The Hill
  
  Medicares Bundled Payment Proposal: Progress on Health Care Payment Reform
- JUN 28, 2016 The Washington Post
  
  Biden holding cancer summit to pump up support for 'moonshot' effort
- MAY 23, 2016
  
  Medicare Proposed Rule Clarifies, But Leaves Work To Be Done, Experts Say
- APR 5, 2016
  
  Report: Nation Should Implement a Medical Device Evaluation System for Safer, Innovative Medical Devices
Research
Selected Grants
- Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) awarded by Food and Drug Administration 2018 - 2023
- Explainability and Trade Secrecy in AI-Enabled Clinical Decision Support, Diagnostic, and Predictive Software awarded by Greenwall Foundation 2019
- AHA project awarded by American Heart Association 2018 - 2019
- West Health Foundation awarded by West Health Policy Center 2018 - 2019
- Convener of Discussions on Medical Policy Issues Impacting Drug Development awarded by Food and Drug Administration 2014 - 2019
- Exploring the Evidence on the Potential Impact of Reducing Areas of Low-Value Care awarded by National Pharmaceutical Council 2018 - 2019
- Guiding Committee Co-Chair role for the Health Care Payment LAN awarded by Mitre Corporation 2016 - 2019
- Support of Regulatory Research to FDA Commitment under the 2012 PDUFA Act awarded by Food and Drug Administration 2013 - 2018
- Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic awarded by Food and Drug Administration 2016 - 2018
- Challenges to Reducing Low-Value Care: Lessons Learned and Future Directions awarded by National Pharmaceutical Council 2017 - 2018
- Accountable Care Policy Gaps and Lessons from the UK and US: A Bi-Directional Study awarded by Health Foundation 2016 - 2018
- Special Analysis of Part D Drug Prices awarded by Mitre Corporation 2018
- Improving our Understanding of Risk Sharing Agreements: A Survey to Learn from Non-Public Activities awarded by National Pharmaceutical Council 2017 - 2018
- Developing a path to value-based reimbursement for Oncology therapies awarded by Lilly USA, LLC 2017 - 2018
- Person Generated Health Data: A new generation of evidence for regulatory decision-making awarded by PatientsLikeMe Inc. 2016 - 2017
- Model Portfolio Plan awarded by Mitre Corporation 2016 - 2017
- GHTC R&D Mapping awarded by PATH 2016 - 2017
- Emerging Models of Collaborative Chronic Cardiac Care awarded by American College of Cardiology Foundation 2016
Publications & Artistic Works
Selected Publications
- Academic Articles
  - Engelgau, MM, Narayan, KMV, Ezzati, M, Salicrup, LA, Belis, D, Aron, LY, Beaglehole, R, Beaudet, A, Briss, PA, Chambers, DA, Devaux, M, Fiscella, K, Gottlieb, M, Hakkinen, U, Henderson, R, Hennis, AJ, Hochman, JS, Jan, S, Koroshetz, WJ, Mackenbach, JP, Marmot, MG, Martikainen, P, McClellan, M, Meyers, D, Parsons, PE, Rehnberg, C, Sanghavi, D, Sidney, S, Siega-Riz, AM, Straus, S, Woolf, SH, Constant, S, Creazzo, TL, de Jesus, JM, Gavini, N, Lerner, NB, Mishoe, HO, Nelson, C, Peprah, E, Punturieri, A, Sampson, U, Tracy, RL, and Mensah, GA. "Implementation Research to Address the United States Health Disadvantage: Report of a National Heart, Lung, and Blood Institute Workshop." Global Heart 13, no. 2 (June 2018): 65-72. (Review) Full Text
  - Sharma, A, Harrington, RA, McClellan, MB, Turakhia, MP, Eapen, ZJ, Steinhubl, S, Mault, JR, Majmudar, MD, Roessig, L, Chandross, KJ, Green, EM, Patel, B, Hamer, A, Olgin, J, Rumsfeld, JS, Roe, MT, and Peterson, ED. "Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care." Journal of the American College of Cardiology 71, no. 23 (June 2018): 2680-2690. (Review) Full Text
  - Wong, CA, Perrin, JM, and McClellan, M. "Making the Case for Value-Based Payment Reform in Children's Health Care." Jama Pediatrics 172, no. 6 (June 2018): 513-514. Full Text
  - Alexander, JH, Corrigan-Curay, J, and McClellan, M. "The Clinical Trials Transformation Initiative: Looking back, looking forward." Clinical trials (London, England) 15, no. 1_suppl (February 2018): 3-4. Full Text
  - Aronson, S, Sangvai, D, and McClellan, MB. "Why a Proactive Perioperative Medicine Policy Is Crucial for a Sustainable Population Health Strategy." Anesthesia and Analgesia 126, no. 2 (February 2018): 710-712. (Review) Full Text
  - Nussbaum, S, McClellan, M, and Metlay, G. "Principles for a Framework for Alternative Payment Models." JAMA 319, no. 7 (February 2018): 653-654. Full Text
  - McClellan, M, and Japinga, M. "The Affordable Care Act: What's Next?." Annual Review of Medicine 69, no. 1 (January 29, 2018): 41-52. Full Text
  - Farmer, SA, Casale, PN, Gillam, LD, Rumsfeld, JS, Erickson, S, Kirschner, NM, De Regnier, K, Williams, BR, Shawn Martin, R, and McClellan, MB. "Payment reform to enhance collaboration of primary care and cardiology a review." Jama Cardiology 3, no. 1 (January 1, 2018): 77-83. (Review) Full Text
  - Gajewski, JL, McClellan, MB, Majhail, NS, Hari, PN, Bredeson, CN, Maziarz, RT, LeMaistre, CF, Lill, MC, Farnia, SH, Komanduri, KV, and Boo, MJ. "Payment and Care for Hematopoietic Cell Transplantation Patients: Toward a Specialized Medical Home for Complex Care Patients." Biology of Blood and Marrow Transplantation 24, no. 1 (January 1, 2018): 4-12. Full Text
  - Maru, D, Maru, S, Nirola, I, Gonzalez-Smith, J, Thoumi, A, Nepal, P, Chaudary, P, Basnett, I, Udayakumar, K, and McClellan, M. "Accountable Care Reforms Improve Women's And Children's Health In Nepal." Health Affairs (Project Hope) 36, no. 11 (November 2017): 1965-1972. Full Text
  - McClellan, M, Udayakumar, K, Thoumi, A, Gonzalez-Smith, J, Kadakia, K, Kurek, N, Abdulmalik, M, and Darzi, AW. "Improving Care And Lowering Costs: Evidence And Lessons From A Global Analysis Of Accountable Care Reforms." Health Affairs (Project Hope) 36, no. 11 (November 2017): 1920-1927. Full Text
  - Daniel, GW, Schneider, M, and McClellan, MB. "Addressing Antimicrobial Resistance and Stewardship: The Priority Antimicrobial Value and Entry (PAVE) Award." Jama 318, no. 12 (September 2017): 1103-1104. Full Text
  - Japinga, M, Saunders, R, Gellad, ZF, and McClellan, M. "The Evolving Payment Reform Landscape: New Opportunities for Gastroenterology Leadership." Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 15, no. 9 (September 2017): 1322-1325. Full Text
  - Dzau, VJ, McClellan, MB, McGinnis, JM, Burke, SP, Coye, MJ, Diaz, A, Daschle, TA, Frist, WH, Gaines, M, Hamburg, MA, Henney, JE, Kumanyika, S, Leavitt, MO, Parker, RM, Sandy, LG, Schaeffer, LD, Steele, GD, Thompson, P, and Zerhouni, E. "Vital Directions for Health and Health Care: Priorities From a National Academy of Medicine Initiative." Jama 317, no. 14 (April 2017): 1461-1470. Full Text
  - Fraiche, AM, Eapen, ZJ, and McClellan, MB. "Moving Beyond the Walls of the Clinic: Opportunities and Challenges to the Future of Telehealth in Heart Failure." JACC. Heart failure 5, no. 4 (April 2017): 297-304. (Review) Full Text
  - McGlynn, EA, and McClellan, M. "Strategies For Assessing Delivery System Innovations." Health Affairs (Project Hope) 36, no. 3 (March 2017): 408-416. Full Text
  - Farmer, SA, Darling, ML, George, M, Casale, PN, Hagan, E, and McClellan, MB. "Existing and Emerging Payment and Delivery Reforms in Cardiology." Jama Cardiology 2, no. 2 (February 2017): 210-217. Full Text
  - Shrank, WH, Saunders, RS, and McClellan, M. "Better Evidence to Guide Payment Reforms: Recognizing the Importance of Perspective." JAMA 317, no. 8 (February 2017): 805-806. Full Text
  - Sorenson, C, Lavezzari, G, Daniel, G, Burkholder, R, Boutin, M, Pezalla, E, Sanders, G, and McClellan, M. "Advancing Value Assessment in the United States: A Multistakeholder Perspective." Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research 20, no. 2 (February 2017): 299-307. Full Text
  - Valuck, T, Blaisdell, D, Dugan, DP, Westrich, K, Dubois, RW, Miller, RS, and McClellan, M. "Improving Oncology Quality Measurement in Accountable Care: Filling Gaps with Cross-Cutting Measures." Journal of managed care & specialty pharmacy 23, no. 2 (February 2017): 174-181. Full Text
  - Audibert, C, Romine, M, Caze, A, Daniel, G, Leff, J, and McClellan, M. "Building a drug development database: challenges in reliable data availability." Drug development and industrial pharmacy 43, no. 1 (January 2017): 74-78. Full Text
  - Zineh, I, Abernethy, D, Hop, C, Bello, A, McClellan, MB, Daniel, GW, and Romine, MH. "Improving the tools of clinical pharmacology: Goals for 2017 and beyond." Clinical pharmacology and therapeutics 101, no. 1 (January 2017): 22-24. Full Text
  - Feinberg, DT, and McClellan, MB. "More Value From Payment Reform in Health Care and Biomedical Innovation." JAMA 316, no. 16 (October 2016): 1653-1654. Full Text
  - McClellan, MB, and Leavitt, MO. "Competencies and Tools to Shift Payments From Volume to Value." Jama 316, no. 16 (October 2016): 1655-1656. Full Text
  - Dzau, VJ, McClellan, M, and McGinnis, JM. "Vital Directions for Health and Health Care: An Initiative of the National Academy of Medicine." Jama 316, no. 7 (August 2016): 711-712. Full Text
  - Farmer, SA, Shalowitz, J, George, M, McStay, F, Patel, K, Perrin, J, Moghtaderi, A, and McClellan, M. "Fully Capitated Payment Breakeven Rate for a Mid-Size Pediatric Practice." Pediatrics 138, no. 2 (August 2016). Full Text
  - Pines, JM, McStay, F, George, M, Wiler, JL, and McClellan, M. "Aligning payment reform and delivery innovation in emergency care." The American journal of managed care 22, no. 8 (August 2016): 515-518.
  - Clough, JD, and McClellan, M. "Implementing MACRA: Implications for Physicians and for Physician Leadership." Jama 315, no. 22 (June 2016): 2397-2398. Full Text
  - Patel, K, Presser, E, George, M, and McClellan, M. "Shifting Away From Fee-For-Service: Alternative Approaches to Payment in Gastroenterology." Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association 14, no. 4 (April 2016): 497-506. (Review) Full Text
  - McClellan, MB, and Sigal, EV. "The 21st Century Cures Act." The New England journal of medicine 373, no. 17 (October 2015): 1677-1678. (Letter) Full Text
  - Valuck, T, Dugan, D, Dubois, RW, Westrich, K, Penso, J, and McClellan, M. "Solutions for filling gaps in accountable care measure sets." The American journal of managed care 21, no. 10 (October 2015): 723-728.
  - Sanghavi, D, Samuels, K, George, M, Patel, K, Bleiberg, S, McStay, F, Thoumi, A, and McClellan, M. "Case study: Transforming cancer care at a community oncology practice." Healthcare 3, no. 3 (September 2015): 160-168. Full Text
  - Thoumi, A, Udayakumar, K, Drobnick, E, Taylor, A, and McClellan, M. "Innovations In Diabetes Care Around the World: Case Studies Of Care Transformation Through Accountable Care Reforms." Health affairs (Project Hope) 34, no. 9 (September 2015): 1489-1497. Full Text
  - McClellan, M. "Accountable care organizations and evidence-based payment reform." Jama 313, no. 21 (June 2015): 2128-2130. Full Text
  - McClellan, MB, Daniel, GW, Dickson, D, Perlmutter, J, Berger, DP, Miller, V, Nussbaum, S, Malin, J, Romine, MH, and Schilsky, RL. "Improving evidence developed from population-level experience with targeted agents." Clinical pharmacology and therapeutics 97, no. 5 (May 2015): 478-487. (Review) Full Text
  - McClellan, MB, and Thoumi, AI. "Oncology payment reform to achieve real health care reform." Journal of Oncology Practice 11, no. 3 (May 2015): 223-230. Full Text
  - Patel, K, Thoumi, A, Nadel, J, O'Shea, J, and McClellan, M. "Transforming oncology care: payment and delivery reform for person-centered care." The American journal of managed care 21, no. 5 (May 2015): 388-393.
  - Daniel, GW, Cazé, A, Romine, MH, Audibert, C, Leff, JS, and McClellan, MB. "Improving pharmaceutical innovation by building a more comprehensive database on drug development and use." Health affairs (Project Hope) 34, no. 2 (February 2015): 319-327. Full Text
  - Outterson, K, Powers, JH, Daniel, GW, and McClellan, MB. "Repairing the broken market for antibiotic innovation." Health Affairs (Project Hope) 34, no. 2 (February 2015): 277-285. Full Text
  - McClellan, MB, and Sigal, EV. "The 21st century cures act: To the editor." New England Journal of Medicine 373, no. 17 (January 1, 2015): 1677-1678. (Letter) Full Text
  - Mostashari, F, Sanghavi, D, and McClellan, M. "Primary care physician-led health reform--reply." Jama 312, no. 14 (October 2014): 1472-null. (Letter) Full Text
  - McClellan, M, and Sigal, E. "New FDA breakthrough-drug category--implications for patients." The New England Journal of Medicine 371, no. 1 (July 2014): 87-88. (Letter) Full Text
  - Wachter, B, McClellan, M, and McKinney, M. "Wachter, McClellan offer takes on measuring quality." Modern Healthcare 44, no. 28 (July 2014): 35-36. (Interview)
  - Mostashari, F, Sanghavi, D, and McClellan, M. "Health reform and physician-led accountable care: the paradox of primary care physician leadership." Jama 311, no. 18 (May 2014): 1855-1856. Full Text
  - McClellan, M, Patel, K, and Sanghavi, D. "Medicare physician payment reform: Will 2014 be the fix for SGR?." Jama Journal of the American Medical Association 311, no. 7 (February 24, 2014): 669-670. Full Text
  - Kocot, SL, Dang-Vu, C, White, R, and McClellan, M. "Early experiences with accountable care in Medicaid: special challenges, big opportunities." Population health management 16 Suppl 1 (January 2013): S4-11. Full Text
- Conference Papers
  - McClellan, M. "Reforming payments to healthcare providers: the key to slowing healthcare cost growth while improving quality?." January 2011. Full Text

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Education, Training, & Certifications

In the News

Selected Grants

Selected Publications

Academic Articles

Conference Papers