Background Note | HBS Case Collection | November 2008 (Revised July 2009)

A Managerial Perspective on Clinical Trials

by Arthur A. Daemmrich


This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70 percent of a drug's total development costs, pharmaceutical and biotechnology leaders need to understand clinical trial management. Likewise, with a growing variety of new product introductions requiring pre-market testing, managers and analysts in many business sectors will benefit from understanding clinical trials.

Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Safety; Biotechnology Industry; Pharmaceutical Industry;


Daemmrich, Arthur A. "A Managerial Perspective on Clinical Trials." Harvard Business School Background Note 709-033, November 2008. (Revised July 2009.)