5 October 2024 - In 1992, patient advocacy groups convinced the FDA to develop an accelerated approval program, which allowed new drugs to be approved on the basis of changes to surrogate measures, such as reductions in HIV viral load, that are reasonably likely to predict actual clinical benefits. 

Accelerated approval was later expanded to cover cancer drugs and corresponding outcomes such as tumour response rate. The goal was to expedite approval of promising new drugs for which definitive evidence of patient benefit was lacking. As part of the deal, manufacturers were charged with conducting post approval studies to show that the drug does in fact benefit patients. If they failed to demonstrate clinical benefit, or to complete these confirmatory trials, the FDA could withdraw the approval.

Read New England Journal of Medicine Perspective