Patient Perspectives on Approval Speed vs Evidentiary Certainty in US Cancer Drug Approvals

What are patients’ views on the trade-off between faster drug approval and evidentiary certainty, and when is this most acceptable?In this qualitative study interviewing 30 patients with breast cancer, participants expressed that high uncertainty about the clinical benefit of a new cancer drug at approval was most acceptable if no alternative treatment options existed or if the anticipated benefit of a new drug was transformative.These findings suggest that patients’ willingness to accept evidentiary uncertainty for faster cancer drug approval does not align with the conditions under which most new cancer drugs are currently approved.

Corresponding Author: Robin Forrest, MSc, PhD, Department of Health Policy, London School of Economics and Political Science, Houghton St, London WC2A 2AE, United Kingdom (r.forrest@lse.ac.uk).

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