Edward Cliff: Excited to share our work on accelerated approval and NCCN guidelines, out today

Edward Cliff, Fellow at Harvard Medical School and Brigham & Women’s Hospital, made the following post on LinkedIn:

“In a JAMA Network Open double, excited to share our work on accelerated approval and NCCN guidelines, out today.

TLDR: We find that most drug-indication pairs are supported by ‘lower-level evidence’ (Cat 2A), even amongst regular approvals

Why are NCCN guidelines important?
– used by public & private payers to determine coverage (incl many off-label indications)
– used by oncologists in increasingly complex & heterogeneous field
– used by companies in marketing
– barometer of what (subset of) oncologists think

We found:
– AA indications had lower evidence (not surprising) & preference (how unmet are the unmet needs?) than regular approval indications
– Majority of converted & de novo regular approvals still Cat 2A: supported by lower-level evidence but >85% consensus among NCCN oncs

Conclusions:
– need better evidence (more RCTs) to inform oncology decision-making
– FDA should (re)consider bar for regular approval
– National Comprehensive Cancer Network® (NCCN®) should consider an intermediate evidence category & explicitly define evidence thresholds

Huge thanks to Benjamin Rome, Rachel Rome & Aaron S. Kesselheim, M.D., J.D., M.P.H. for their wise mentorship!”

For details click here.
Source: Edward Cliff/LinkedIn