Author Contributions: Dr Califf had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Califf, Zarin, Sherman, Tasneem.
Acquisition of data: Zarin, Tasneem.
Analysis and interpretation of data: Califf, Zarin, Kramer, Aberle, Tasneem.
Drafting of the manuscript: Califf, Sherman.
Critical revision of the manuscript for important intellectual content: Califf, Zarin, Kramer, Aberle, Tasneem.
Statistical analysis: Califf, Aberle.
Obtained funding: Califf, Kramer.
Administrative, technical, or material support: Califf, Zarin, Tasneem.
Study supervision: Califf, Zarin, Sherman.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Califf reports receiving research grants that partially support his salary from Amylin, Johnson & Johnson (Scios), Merck, Novartis Pharma, Schering Plough, Bristol-Myers Squibb Foundation, Aterovax, Bayer, Roche, and Lilly; all grants are paid to Duke University. Dr Califf also consults for TheHeart.org, Johnson & Johnson (Scios), Kowa Research Institute, Nile, Parkview, Orexigen Therapeutics, Pozen, Servier International, WebMD, Bristol-Myers Squibb Foundation, AstraZeneca, Bayer-OrthoMcNeil, BMS, Boerhinger Ingelheim, Daiichi Sankyo, GlaxoSmithKline, Li Ka Shing Knowledge Institute, Medtronic, Merck, Novartis, sanofi-aventis, XOMA, and University of Florida; all income from these consultancies is donated to nonprofit organizations, with the majority going to the clinical research fellowship fund of the Duke Clinical Research Institute. Dr Califf holds equity in Nitrox LLC. Dr Kramer is the executive director of the Clinical Trials Transformation Institute (CTTI), a public-private partnership. A portion of Dr Kramer's salary is supported by pooled funds from CTTI members (https://www.ctti-clinicaltrials.org/about/membership). Dr Kramer reports receiving a research grant from Pfizer that supports a small percentage of her salary; this grant is paid to Duke University. Dr Kramer also served on an advisory board for the “Pharmacovigilance Center of Excellence” at GlaxoSmithKline, for which she received an honorarium. Financial disclosure information for Drs Califf and Kramer is also publicly available at https://www.dcri.org/about-us/conflict-of-interest. No other disclosures were reported.
Funding/Support: Financial support for this project was provided by grant U19FD003800 from the US Food and Drug Administration awarded to Duke University for the Clinical Trials Transformation Initiative.
Role of the Sponsors: The US Food and Drug Administration participated in the design and conduct of the study via one of the coauthors (R.E.S.); in the collection, management, analysis, and interpretation of the data; and in the preparation, review, and approval of the manuscript.
Additional Contributions: We gratefully acknowledge the contributions of CTTI Project Leader Jean Bolte, RN (Duke Clinical Research Institute), and National Library of Medicine staff members Nicholas Ide, MS; Rebecca Williams, PhD; and Tony Tse, PhD, to this project. We also thank Jonathan McCall, BA (Duke Clinical Research Institute), for editorial assistance with the manuscript. None received compensation for their contributions besides their salaries.