About the Authors

Jessica E. Morse

Roles Conceptualization, Formal analysis, Investigation, Writing – original draft, Writing – review & editing

Affiliation Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States of America

Sara B. Calvert

Roles Conceptualization, Formal analysis, Investigation, Project administration, Writing – review & editing

sara.calvert@duke.edu

Affiliation Clinical Trials Transformation Initiative, Duke University Medical Center, Durham, North Carolina, United States of America

Claire Jurkowski

Roles Conceptualization, Investigation, Writing – review & editing

Affiliation Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb, Hopewell, New Jersey, United States of America

Melissa Tassinari

Roles Conceptualization, Investigation, Writing – review & editing

Affiliation Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America

Catherine A. Sewell

Roles Formal analysis, Investigation, Writing – review & editing

Affiliation Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America

Evan R. Myers

Roles Conceptualization, Formal analysis, Investigation, Methodology, Supervision, Writing – review & editing

Affiliation Department of Obstetrics & Gynecology and Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, United States of America

Competing Interests

JEM, MT, CAS, and ERM have no competing interests related to this research or manuscript. SBC is an employee of Duke University, the recipient institution of the FDA cooperative agreement and grant and CTTI membership fees. A portion of her salary is paid from these sources. CJ was an employee of Bristol-Myers Squibb at the time of the project. This does not alter our adherence to PLOS ONE policies on sharing data and materials.