Simonetti, Arianna http://orcid.org/0000-0003-4711-7858
Colilla, Susan
Edwards, Brian http://orcid.org/0000-0002-7241-1787
Kübler, Jürgen
Lackey, Leila http://orcid.org/0000-0001-8434-2638
Rodriguez, Lisa
Talbot, Susan
Yang, Hong http://orcid.org/0000-0002-0057-6566
Wang, William
Williams, Danae
Higginson, James Matthew
Article History
Accepted: 28 April 2024
First Online: 1 June 2024
Declarations
:
: No funding was received for conducting the interviews and the preparation of this manuscript.
: SC is an employee of Teva Pharmaceuticals. BE and JK act as a consultant for the pharmaceutical industry. ST is an employee of Amgen Inc. WW is an employee of Merk Sharp & Dohme LLC. DW is an employee of GlaxoSmithKline (GSK). JMH was an employee of Merck KGaA when the work was conducted and is currently an employee of GSK. This publication reflects the views of the authors and should not be construed to represent the FDA and other employers’ views or policies.
: The interviews were conducted under an FDA-IRB waiver, approved on August 24, 2020.
: All participants provided verbal or written consent to participate.
: Not applicable.
: Data sharing is not applicable to this article. Interview transcripts are not available to be shared openly as they were anonymized.
: Not applicable.
: AS and JMH authored the manuscript, served as lead evaluators for the interviews, designed the coding system and conducted quality control and analyses. BE designed the interviews. SC, JK, LL, LR, ST, HY, WW, DW served as interviewers. AS, SC, BE, JK, LL, LR, ST, HY, WW, DW, JMH reviewed the manuscript. All authors read and approved the final version.