Jan 19, 2017

Sometimes, you just need another clinical trial

Alton Strupp / The Courier-Journal via AP

The FDA just put out a report that's making the rounds among health care wonks. It's about 22 clinical trials of new drugs where the results in the early trials were wildly different than they were in the later, broader ones.

Here's what Joshua Sharfstein, a former FDA deputy commissioner and former secretary of the Maryland health department, tweeted about the report:

Why it matters: It's likely to provide new ammunition to the FDA's defenders as Republicans in Congress, and some Democrats, push for speedier approvals of new drugs. The report listed cases where the Phase 3 trials — which are conducted on broader groups of people than the earlier Phase 2 trials — showed that the new drugs might not be effective or safe, or both.

Go deeper