Precision Medicines Approved More Quickly, With Less Data
From the article:
Pivotal trials for precision medicines were scarcer, less likely to be controlled or blinded, and had fewer participants than those for other agents, the study found.
The less rigorous design makes it more challenging to determine the true magnitude of benefit for some of these drugs, said study co-author Jonathan Darrow, JD, MBA, of Harvard Medical School and Brigham & Women's Hospital in Boston, in a phone interview.
When it comes to the speedier development and approval of precision medicines versus nonprecision medicines and the apparent reliance on smaller and fewer trials with less exacting parameters, Darrow had two concerns.
Read more here!clinical research fda health law policy pharmaceuticals precision medicine