The Industrialization Of Clinical Research

PROLOGUE: The brave new world of clinical research has sprung up so quickly and has become so vast that neither policymakers nor private-sector pioneers have been able to stay ahead of the complicated business, ethical, and regulatory issues that have accompanied the exciting developments in this new enterprise. With for-profit entities now dominating both the pace of and the market for clinical research, the question of oversight has become a critical one. As Dick Rettig points out in this paper, the business of clinical research has largely been a response to a science that is “ripe for exploitation,” but it is not clear that the proper structures are in place to keep the business and the science in balance. As leaders in both sectors stake their claims on this new industry, perhaps they would do well to follow the credo of an earlier business pioneer, John D. Rockefeller. No stranger to the politics of industrialization, Rockefeller stated in a 1941 speech, “I believe that every right implies a responsibility; every opportunity, an obligation; every possession, a duty.” Rettig is a senior social scientist at RAND in Washington, D.C. He is a visiting scholar at the Agency for Healthcare Research and Quality (AHRQ) and a visiting professor at the International Center for Health Outcomes and Innovation Research at the Columbia University School of Public Health in New York City. He holds a doctorate in political science from the Massachusetts Institute of Technology in Cambridge. ABSTRACT: Recent controversies over the protection of human subjects, payment of physicians for recruiting patients to clinical trials, Food and Drug Administration (FDA) removal of approved drugs from the market, and reporting of results of clinical trials have highlighted important facets of clinical research. Less visible has been the industrialization of clinical research, and especially of clinical trials, that is, its emergence as a “line of business” of substantial magnitude and rapid growth. The growth of drug-industry outsourcing of clinical trials and the concomitant rise of a contract research industry are described in this paper, which argues for greater transparency in the conduct of both publicly and privately sponsored clinical trials.