Legislative and regulatory changes are allowing drugs, medical devices, and digital health technologies to gain approval based on low-quality evidence. The resulting uncertainty about risks and benefits for medical products may compromise bioethical principles including autonomy and non-maleficence. The team will assess if and how physicians convey this uncertainty to patients. A modified Delphi panel will identify consensus solutions to enhance patient protection and inform a regulatory framework that reconciles ethical principles with the need to generate new knowledge to inform care for patients.
A Bioethical Framework to Inform Use of Novel Drugs, Devices, and Digital Health Technologies Approved with Incomplete Evidence
University of California San Francisco
Sanket S. Dhruva et al., Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel, ASCPT, March 2022.Read more
Jonathan J. Darrow et al., Changing FDA Approval Standards: Ethical Implications for Patient Consent, Journal of General Internal Medicine, Apr 2021.Read more