Ravi B. Parikh: Is Accelerated FDA Approval 23 Times Stronger than the Traditional?
Ravi B. Parikh, Director of Human-Algorithm Collaboration Lab (HACLab) and Associate Professor at Winship Cancer Institute of Emory University, shared a post on LinkedIn about a paper he co-authored with colleagues published in JAMA Network Open:
“New in JAMA Network Open: How do oncologists change prescribing after FDA Accelerated vs. Traditional Approval?
Answer – much more robustly to AA! Using Flatiron Health data, we show that prescribing increases 23 vs. 1 percentage-points after AA vs. after TA.
What does this mean? Oncologists
1) are unconcerned/unaware of the provisional evidence underlying AA (h/t Sanket Dhruva paper linked here) and
2) attach low value to traditional approval. Argument for FDA speeding access to confirmatory evidence after (or before) AA.
Special thanks to Arnold Ventures for support, and great to co-lead this with Ronac Mamtani, Holly Fernandez Lynch, Steven Joffe, Rebecca Hubbard, Ernesto Ulloa, and William Ferrell.”
Title: Prescribing Changes After Accelerated vs Regular Approval of Oncology Therapies
Authors: Ravi B. Parikh, Ernesto Ulloa-Pérez, Martin Kurian, Rebecca Hubbard, Steven Joffe, Holly Fernandez Lynch, Ronac Mamtani
You can read the Full Article in JAMA Network Open.
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