Saunders-Hastings, Patrick
Zhou, Cindy Ke
Hobbi, Shayan
Wong, Hui-Lee
Lloyd, Patricia
Boyd, Eva
Alawar, Nader
Clarke, Tainya C.
Beers, Jeff
Burrell, Timothy
Shoaibi, Azadeh
Funding for this research was provided by:
U.S. Food and Drug Administration
Article History
Received: 15 February 2022
Accepted: 2 June 2022
First Online: 18 June 2022
Declarations
:
: As a secondary data analysis involving no personal health information, IRB approval was not needed. Data used in this study were anonymized before its use, and no administrative permissions were required to access raw data. All research was performed in accordance with the Declaration of Helsinki guidelines and declarations.
: Not applicable.
: This project was funded through the U.S. Food and Drug Administration Center for Biologics Evaluation and Research Biologics Effectiveness and Safety (BEST) Initiative. Several co-authors hold commercial affiliations with Gevity Consulting Inc. (PSH, EB), IBM Consulting (SH, JB), and IBM Watson Health (TB). Gevity Consulting Inc., IBM Consulting, and IBM Watson Health provided support in the form of salaries for authors but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.