TY - JOUR
T1 - "I Think It's Been Met With a Shrug:" Oncologists' Views Toward and Experiences With Right-to-Try
AU - Smith, Cambray
AU - Stout, Jeremiah
AU - Adjei, Alex A.
AU - Buckner, Jan
AU - Wentworth, Mark
AU - Tilburt, Jon
AU - Master, Zubin
N1 - Publisher Copyright:
© The Author(s) 2020. Published by Oxford University Press. All rights reserved.
PY - 2021/6/1
Y1 - 2021/6/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85104889386&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85104889386&partnerID=8YFLogxK
U2 - 10.1093/jnci/djaa137
DO - 10.1093/jnci/djaa137
M3 - Article
C2 - 32882030
AN - SCOPUS:85104889386
SN - 0027-8874
VL - 113
SP - 735
EP - 741
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
IS - 6
ER -