Difficulty With Binary Voting Among FDA Oncology Advisory Committee Members

TL;DR

This study explores how often FDA advisory committee members report difficulty in voting to approve cancer drugs.

Contribution

The study provides new insights into the challenges faced by FDA advisory committee members during drug approval voting.

Findings

Members frequently report difficulty in binary voting decisions for drug approvals.

The qualitative analysis reveals factors influencing voting challenges in oncology drug approvals.

The study highlights the subjective nature of drug approval decisions in advisory committees.

Abstract

This qualitative study investigates the frequency of reports of difficulty in voting for drug approval by members of the Food and Drug Administration Oncologic Drugs Advisory Committee.