The origin of randomization and the impact of clinical trials will be discussed today in the Eugene Braunwald Lecture on Future Directions in Cardiovascular Medicine. Keynote speaker Jeffrey M. Drazen, MD, will explore the history of clinical trials, the challenges associated with transparency and misuse, and potential approaches for the future.

“In medicine we can distinguish what we think from what we know through the use of well-designed, cleanly-performed, and conservatively-interpreted clinical trials,” says Drazen, editor-in-chief of the New England Journal of Medicine, and the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School. “The key element of these trials is randomization.” Drazen will use examples of the treatment of tuberculosis and the polio vaccine to illustrate how randomization came into popular use.

"The final step in the reporting of clinical trials is the availability of the individual patient data underlying reports in the literature. The process for such reporting is still in formulation, but I will end with a proposed approach to reaching this goal." — Jeffrey M. Drazen, MD

“To help keep the clinical trial reporting process as transparent as possible, the idea of publicly-registering clinical trials at their outset was raised and became the norm in 2005,” says Drazen. “Shortly thereafter, U.S. legislation required reporting of aggregate clinical trial results, but the uptake of this mandate had been slow.” In 2016, the reporting of aggregate results in a trial database became required by law.

“The final step in the reporting of clinical trials is the availability of the individual patient data underlying reports in the literature. The process for such reporting is still in formulation, but I will end with a proposed approach to reaching this goal.”

The Eugene Braunwald Lecture on Future Directions in Cardiovascular Medicine and the Best of JACC Journals session will take place today from 12:30 – 1:45 p.m. in Hall D (Main Tent).

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