Comet Calendar

Scott Podolsky, M.D.
Harvard Medical School; Massachusetts General Hospital

The 'Gold Standard' in Perspective: Randomized Controlled Trials and the Shifting Construction of Therapeutic Efficacy.

How do we know whether a remedy “works”?  Questions of efficacy have concerned physicians for centuries, and regulators like the FDA for decades.  In the era of COVID-19, such considerations have likewise become front-page news, of interest not only to physicians and regulators, but to politicians, payors, and the public at large.  This talk examines the interrelated methodological, social, regulatory, ethical, and economic histories of the controlled clinical trial as it has emerged over the past two centuries (and especially over the past 75 years) to become the “gold standard” for evaluating therapeutic interventions.  It describes the controlled clinical trial as a dynamic, evolving entity, a powerful tool that has nonetheless elicited tensions concerning its applicability to all fields of medical inquiry, ethics and internal validity of its production, the generalizability of its findings to the “real” world, and the overall ecology of medical knowledge that such trials have produced.


Scott Podolsky, M.D., is a Professor of Global Health and Social Medicine at Harvard Medical School, Director of the Center for the History of Medicine at the Francis A. Countway Library of Medicine, and a primary care physician at Massachusetts General Hospital.

He is the co-author (with Alfred Tauber) of Generation of Diversity: Clonal Selection Theory and the Rise of Molecular Immunology (Harvard University Press, 1997), co-editor (with Charles Bryan) of Oliver Wendell Holmes: Physician and Man of Letters (Science History Publications, 2009), and author of Pneumonia before Antibiotics: Therapeutic Evolution and Evaluation in Twentieth Century America (Johns Hopkins University Press, 2006) and The Antibiotic Era: Reform, Resistance, and the Pursuit of a Rational Therapeutics (Johns Hopkins University Press, 2015).  He has also written extensively on the history of clinical trials, serves on the editorial board of the online James Lind Library dedicated to the history of clinical trials, and is one of the co-authors of the James Lind Library’s Introduction to Fair Tests of Treatments (2019).  His present book-length project is on the related history of the medical journal and the medical profession in the U.S. over the past two centuries.

This is a hybrid event. Access this link at 4:30 p.m. for the live streaming of the lecture:

Erik Jonsson Academic Center (JO), 4.614
800 W. Campbell Road, Richardson, Texas 75080-3021


Harry W. Bass Jr. School of Arts, Humanities, and Technology
Magdalena Grohman

UTD strives to create inclusive and accessible events in accordance with the Americans with Disabilities Act (ADA). If you require an accommodation to fully participate in this event, please contact the event coordinator (listed above) at least 10 business days prior to the event. If you have any additional questions, please email and the AccessAbility Resource Center at

  • Matthew Makowka
  • Amanda Miller
  • Jeff Young

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