Cancer Survivors' and Caregivers' Understanding of FDA Accelerated Approval Disclosures

Area of Science:

• Oncology
• Health Communication
• Regulatory Science

Background:

• The US Food and Drug Administration (FDA) accelerated approval pathway expedites drug development for serious illnesses.
• Key disclosures include approval basis, unknown benefits, and ongoing trials.
• Understanding these disclosures is crucial for patient decision-making.

Purpose of the Study:

• To assess cancer survivors' and caregivers' understanding of FDA accelerated approval disclosures.
• To evaluate the impact of "unknown outcomes" and "confirmatory trials" disclosures on comprehension.

Main Methods:

• 202 cancer survivors and 199 caregivers were randomly assigned to view a fictitious drug website with varying disclosures.
• Participants were exposed to disclosures about clinical benefits, unknown outcomes, and ongoing trials.
• Comprehension and recognition of disclosure elements were measured.

Main Results:

• Participants noticed and recognized the three disclosure elements.
• The "unknown outcomes" disclosure significantly improved comprehension across measures.
• Agreement that more data is needed was consistent, regardless of confirmatory trial disclosure.

Conclusions:

• Accelerated approval disclosures, particularly regarding unknown outcomes, enhance patient and caregiver understanding.
• Improved comprehension supports informed participation in critical treatment decisions.
• Effective communication of drug uncertainties is vital in oncology prescription drug information.