Accepted for Publication: January 31, 2013.
Published Online: April 29, 2013. doi:10.1001/jamainternmed.2013.627
Author Contributions:Study concept and design: Hirsch, Califf, Tasneem, Dilts, and Abernethy. Acquisition of data: Hirsch and Tasneem. Analysis and interpretation of data: Hirsch, Cheng, Horton, Chiswell, Schulman, Dilts, and Abernethy. Drafting of the manuscript: Hirsch, Califf, Horton, Dilts, and Abernethy. Critical revision of the manuscript for important intellectual content: Califf, Cheng, Tasneem, Horton, Chiswell, Schulman, Dilts, and Abernethy. Statistical analysis: Hirsch, Cheng, Horton, and Chiswell. Obtained funding: Califf. Administrative, technical, and material support: Califf, Tasneem, Schulman, Dilts, and Abernethy. Study supervision: Hirsch, Schulman, Dilts, and Abernethy.
Conflict of Interest Disclosures: Dr Abernethy reported receiving research funding from the National Institutes of Health, Agency for Healthcare Research and Quality, Robert Wood Johnson Foundation, Pfizer, Helsinn Therapeutics, Amgen, Kanglaite, Alexion, Biovex, DARA Therapeutics, Dendreon, and Mi-Co; having consulting agreements with Amgen, Bristol-Myers Squibb, Helsinn Therapeutics, Novartis, and Pfizer; and serving as a paid board member for Advoset and Orange Leaf Associates. Dr Califf reported receiving research funding from Amylin Pharmaceuticals, Aterovax, Bayer, Bristol-Myers Squibb, Johnson & Johnson/Scios Inc, Merck, Novartis, Roch, and National Institutes of Health; having consulting agreements with Bristol-Myers Squibb, Johnson & Johnson/Scios, Kowa Research Institute, Nile, Novartis, Parkview, Orexigen Therapeutics, Pozen, Servier, and WebMD; serving as speaker for Amylin; and having equity in Nitrox, LLC. Dr Cheng reported receiving research funding from the National Cancer Institute. Dr Dilts reported receiving funding from the National Cancer Institute and nominal consulting agreements with Celgene Corporation and Scimega. Dr Hirsch reported receiving research funding from Academy Health, Bristol-Myers Squibb, Dendreon, and Pfizer; and having ownership equity with Pioneer Surgical Technology. Dr Schulman reported receiving research funding from Actelion Pharamaceuticals, Allergan, Alnylam Pharmaceuticals, Amgen, Amylin Pharmaceuticals, Arthritis Foundation, Astellas Pharma, Bristol-Myers Squibb, The Duke Endowment, Inspire Pharmaceuticals, Johnson & Johnson, Kureha Corporation, Medtronic, Merck, Nabi Biopharmaceuticals, National Patient Advocate Foundation, NovaCardia, Novartis, OSI Eyetech, sanofi-aventis, Scios, Tengion, Theravance, Inc, Verizon, and Vertex Pharmaceuticals. Dr Schulman reported having consulting agreements with Certified Medical Representatives Institute, The Commonwealth Fund, East Carolina University, Enabled, Forest Laboratories, GlaxoSmithKline, Johnson & Johnson, McKinsey & Company, Medical Decisions Network, Medtronic, Merck, National Pharmaceutical Council, Novartis, Novo Nordisk, Orexigen Therapeutics, Quintiles Transnational, Shire, Social and Scientific Systems, Wallen and Associates, and WebMD; and having equity in and/or serving on the board of directors of Alnylam Pharmaceuticals, Tellus Operating Group.
Funding/Support: Financial support for this project was provided by grant U19FD003800 from the FDA, awarded to Duke University for the Clinical Trials Transformation Initiative.
Previous Presentations: The results of this study were presented at the American Society of Clinical Oncology annual meeting; June 5, 2011; Chicago, Illinois; and the Society of Clinical Trials meeting; May 21, 2012; Miami, Florida.
Additional Contributions: Jean Bolte, project leader of the Clinical Trials Transformation Initiative, provided assistance with this project. Suanna Bruinooge at the American Society of Clinical Oncology reviewed the manuscript, and Jonathan McCall provided editorial assistance as part of his regular duties as a medical editor employed by the Duke Clinical Research Institute.
This article was corrected for errors on August 6, 2013.