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Article History

Accepted: 17 February 2025

First Online: 12 March 2025

Declarations

:

: No financial support was received.

: Evidera performs healthcare research for a wide range of biopharmaceutical and biotechnology companies. At the time of manuscript submission, M.Y.S., R.D., D.S. and V.N. were all full-time employees of Evidera, Inc., a healthcare research consultancy and business unit of Pharmaceutical Product Development (PPD), the clinical research business unit of Thermo Fisher Scientific (TFS). M.Y.S., D.S. and R.D. are also shareholders in TFS. Additionally, M.Y.S. is an adjunct faculty member in the Department of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, Los Angeles, CA. P.B., G.A.T. and A.H. have no conflict of interest. P.B. is an editorial board member of Drug Safety. P.B. was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. Additionally, the views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organisations with which any authors are employed and/or affiliated.

: This work is not human subject research. No ethics approval was necessary for this study.

: Not applicable.

: This manuscript has no associated data.

: Not applicable.

: M.Y.S. designed the study, wrote the first draft of the manuscript, assisted with the literature review, prepared the case study and Tables 1 and 2 and prepared the final draft for submission. D.S. prepared Table 3. M.Y.S., R.D. and D.S. developed Tables 4 and 5. V.N. conducted the literature review. M.Y.S. and A.H. co-wrote the description of the mixed-methods designs for the formative and summative evaluations. G.T. assisted M.Y.S. in developing the case study; P.B. assisted in the study design. All authors reviewed and approved the final version of the manuscript.