Author Contributions: Dr Li 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: Li, Eisenstein, Grabowski, Murphy, Califf, Benjamin.
Acquisition of data: Li, Reid, Mangum, Goldsmith, Murphy, Benjamin.
Analysis and interpretation of data: Li, Eisenstein, Mangum, Schulman, Califf, Benjamin.
Drafting of the manuscript: Li, Eisenstein, Grabowski, Benjamin.
Critical revision of the manuscript for important intellectual content: Li, Eisenstein, Reid, Mangum, Schulman, Goldsmith, Murphy, Califf, Benjamin.
Statistical analysis: Li, Eisenstein, Grabowski, Benjamin.
Obtained funding: Li, Califf, Benjamin.
Administrative, technical, or material support: Li, Reid, Mangum, Goldsmith, Murphy, Califf.
Study supervision: Reid, Murphy.
Financial Disclosures: Dr Li reported receiving research support from Bristol-Myers Squibb, Sanofi-Aventis, Pfizer, the National Institute of Child Health and Human Development (NICHD), the National Heart, Lung, and Blood Institute (NHLBI), First Horizon, MedImmune, and ID Biomed; and salary support from the National Institutes of Health (NIH). Dr Li does not own any stock or hold financial interest in any of the listed companies. Dr Eisenstein reported receiving research support from Berlex Laboratories, Bristol-Myers Squibb, and Roche Global Pharmacoeconomic Research. Dr Schulman reported receiving research and salary support from Actelion Pharmaceuticals, Allergan Pharmaceuticals, Amgen, Bristol-Myers Squibb, Ernst & Young, Genentech, GlaxoSmithKline, IBM Center for Healthcare Management, Inspire Pharmaceuticals, Johnson & Johnson, Kureha Corporation, Lilly Foundation, Medtronic, NABI Biopharmaceuticals, Novartis, Pfizer, Pharmacia, Purdue Pharma, Sanofi-Aventis, Scios, Theravance, Wyeth, and Yamanouchi USA Foundation; personal income for consulting from Genentech and The Health Strategies Consultancy; has equity in and is on the board of directors of Cancer Consultants; has equity in and is on the executive board of Faculty Connection LLC; and has equity in Alnylam Pharmaceuticals. Dr Califf reported research and salary support from Guilford Pharmacuticals, Millennium Pharmaceuticals, the NIH, Novartis, and Schering Plough; and personally receiving funding support from Conceptis and has equity in NITROX LLC. Educational activities or lectures provided by Dr Califf generate revenue for Duke University from the following companies: Aventis, Bristol-Myers Squibb, Conceptis, Guilford Pharmaceuticals, Merck, Novartis, Pfizer, Sanofi-Aventis, Schering Plough, and the Medicines Company. Dr Benjamin reported receiving research support from Cape Cod Associates, Astellas, MedImmune, NABI Biopharmaceutical, the National Institutes of Allergy and Infectious Diseases (NIAID), NICHD, Pediatrix, Pfizer, Rockeby, Thrasher Research, and Vicuron; fellowship funding from AstraZeneca and Johnson & Johnson; speaking and consulting honoraria from Enzon, Ligocyte, Ross, and Vicuron. Dr Benjamin does not own any stock or hold financial interest in any of the listed companies. All consulting relationships were terminated with the start of joint appointment with the US Food and Drug Administration in October 2005. No other authors reported financial disclosures.
Funding/Support: This work was supported by grants 1U10-HD45962-02 and HD-044799-02 from the NICHD (Dr Benjamin) and grant 1UL 1RR024128-01 from the National Center for Research Resources and NIH (Drs Li, Califf, and Benjamin).
Role of the Sponsors: The design and conduct of the study, collection, management, analysis, and interpretation of the data, and preparation, review, and approval of the manuscript were independent of any funding organization.
Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the opinions of the US Food and Drug Administration or any other federal agency. No official endorsement by the US Food and Drug Administration is provided or should be inferred.
Acknowledgment: We thank Rex H. Edwards, BA, Duke University Medical Center, Duke Clinical Research Institute Outcomes Group, for his efforts in performing data analysis for this article. Mr Edwards did not receive any monetary compensation for his assistance.