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Oversight of Right‐to‐Try and Expanded Access Requests for Off‐Trial Access to Investigational Drugs
Author(s) -
Chapman Carolyn Riley,
Eckman Jared,
BatemanHouse Alison S.
Publication year - 2020
Publication title -
ethics and human research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.353
H-Index - 32
eISSN - 2578-2363
pISSN - 2578-2355
DOI - 10.1002/eahr.500038
Subject(s) - investigational drugs , expanded access , investigational device exemption , clinical trial , food and drug administration , psychological intervention , medicine , institutional review board , clinical research , business , product (mathematics) , pharmacology , psychiatry , oncology , geometry , mathematics
For decades, the U.S. Food and Drug Administration (FDA) has provided an “expanded access” pathway that allows patients who meet qualifying conditions to gain access outside a clinical trial to an investigational medical product being tested to see if it is safe and effective for a specific use. The Right to Try (RTT) Act, enacted in 2018, created a second mechanism for off‐trial, or non‐trial, access to investigational drugs. In contrast to the expanded access pathway, the federal RTT pathway does not require the involvement of the FDA or an institutional review board (IRB). Given that physicians, drug manufacturers, and medical institutions now have a choice whether to assist individual patients through the expanded access or the federal RTT pathway, we review the differences between these options and discuss the benefits and burdens of IRB involvement in requests to access interventions through the pathways. We also suggest ways in which IRB oversight may be further improved.