Merck’s Quality-Of-Life Argument For Ridaforolimus Draws ODAC Tongue-Lashing
Executive Summary
The pivotal study failed to capture patient-reported outcomes data on drug-related side effects, and use of observational data to support the view that the mTOR inhibitor has a positive risk/benefit profile is “crazy,” committee members said.
You may also be interested in...
Oncology Experience With PROs
There has been some success in getting PRO data into oncology labeling, but also notable failures.
Accelerated Approval Could Spur Development Of Patient-Reported Outcomes Tools
A subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma was that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement.
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations
US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.