Journal
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE
Volume 113, Issue 6, Pages 735-741Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/jnci/djaa137
Keywords
-
Categories
Funding
- National Center for Advancing Translational Sciences [UL1 TR002377]
- Center of Excellence in Regulatory Science and Innovation Scholars Award [U01FD005938]
Ask authors/readers for more resources
Most oncologists have limited familiarity with the federal Right-to-Try (RTT) Act, and some are confused about the legislation. While interested in decreased regulatory burdens, concerns were raised about safety, oversight, structure, data collection, and potential patient expectations. Few oncologists have discussed or attempted to obtain drugs through RTT, leading to questions about its practicality and suggestions for alternative ways to improve access.
Background: The federal Right-to-Try (RTT) Act created an alternate regulatory pathway for preapproval access to investigational drugs. A few studies have examined the experiences of physicians with the Food and Drug Administration's Expanded Access Programs, but to our knowledge, no study has yet to examine their attitudes and experiences toward RTT. Methods: This study explored the views of 21 oncologists at a major cancer center with 3 main sites across the United States using semi-structured interviews and qualitative analysis. Participants were selected to have experience with Expanded Access Programs. Results: Most oncologists had limited familiarity with RTT, and several reported confusion about the legislation, including whether patients have a right to investigational drugs and an obligation for companies to provide them. Although oncologists were interested in decreased regulatory burdens, 3 areas of concern were articulated: lack of safety and oversight, unclear structure and no provision for data collection, and potential heightening of patient expectations. Only 4 oncologists had experience discussing RTT, and none formally attempted to obtain the drug through this mechanism. Participants questioned the practicality of RTT legislation and suggested alternative ways to improve access. Conclusions: The study provides foundational empirical data underlying challenging ambiguities by experienced oncologists familiar with off-trial use of investigational therapeutics and reaffirms the role of physicians and regulatory bodies in mitigating the risks of investigational drugs. Our findings highlight the need for medical centers to inform oncologists about RTT and other preapproval pathways so that they are able to address questions from patients interested in nontrial investigational drugs.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available