New England Journal of Medicine
January 5, 2017  Vol. 376 No. 1
http://www.nejm.org/toc/nejm/medical-journal

Review Article
The Changing Face of Clinical Trials
Jeffrey M. Drazen, M.D., David P. Harrington, Ph.D., John J.V. McMurray, M.D., James H. Ware, Ph.D., Janet Woodcock, M.D., Editors
The Large Pharmaceutical Company Perspective
Michael Rosenblatt, M.D.
N Engl J Med 2017; 376:52-60 January 5, 2017 DOI: 10.1056/NEJMra1510069
Large pharmaceutical companies conduct clinical trials to evaluate efficacy and identify safety issues for candidate drugs as effectively, efficiently, and expeditiously as possible, while addressing simultaneously the requirements of regulatory authorities across the globe. To put the fewest people at risk and to learn the most, these trials often are configured to provide evidence for health care providers, regulatory approval, and reimbursement from health agencies. Because there are so many unknowns, pharmaceutical research and development is a high-risk business with the highest failure rate for new product candidates of any industry.