Congress and FDA nominee heap love on ‘adaptive trials’ image

Science, April 7, 2017
Kelly Servick, quoting Rachel E. Sachs (Academic Fellow Alumna)


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From the article:

“‘Adaptive clinical trials’ is one of those buzzwords that get brought up all the time,” says Rachel Sachs, an innovation and health law professor at Washington University in St. Louis in Missouri, and “there is definitely real momentum to actually do more trials this way.” She notes that in the 21st Century Cures Act, signed into law this past December, Congress required that FDA issue guidance and hold a public meeting to clarify how drug sponsors can use adaptive trials in their submissions for drug and device approvals. Legislation that must pass this year to reauthorize FDA’s user fee program commits the agency to create a pilot program to review such innovative trial proposals and the computer simulations that often guide them.

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biotechnology fda health care finance health law policy pharmaceuticals rachel sachs regulation