Robert Califf (Michael Brochstein/Sipa USA via AP Images)

Re­al world ev­i­dence: Lessons learned from an FDA pi­lot show the lim­its of em­u­lat­ing RCTs

On­ly about half of a se­lect group of clin­i­cal tri­als could be well-em­u­lat­ed with avail­able re­al world ev­i­dence, ac­cord­ing to the new­ly dis­cussed re­sults of an FDA pi­lot pro­gram.

The FDA-fund­ed pro­gram, known as RCT-DU­PLI­CATE, helped re­searchers from the Brigham and Women’s Hos­pi­tal in Boston try to eval­u­ate whether ran­dom­ized con­trolled tri­als can be du­pli­cat­ed with RWE across a range of ther­a­peu­tic ar­eas.

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