Sponsorship, authorship, and accountability.

AS EDITORS OF GENERAL MEDICAL JOURNALS, WE RECognize that the publication of clinical research findings in respected peer-reviewed journals is the ultimate basis for most treatment decisions. Public discourse about this published evidence of efficacy and safety rests on the assumption that clinical trials data have been gathered and are presented in an objective and dispassionate manner. This discourse is vital to the scientific practice of medicine because it shapes treatment decisions made by physicians and drives public and private health care policy. We are concerned that the current intellectual environment in which some clinical research is conceived, study subjects are recruited, and the data analyzed and reported (or not reported) may threaten this precious objectivity. Clinical trials are powerful tools; like all powerful tools, they must be used with care. They allow investigators to test biological hypotheses in living patients, and they have the potential to change the standards of care. The secondary economic impact of such changes can be substantial. Welldone trials published in high-profile journals may be used to market drugs and medical devices, potentially resulting in substantial financial gain for the sponsor. But powerful tools must be used carefully. Patients participate in clinical trials largely for altruistic reasons—that is, to advance the standard of care. In the light of that truth, the use of clinical trials primarily for marketing, in our view, makes a mockery of clinical investigation and is a misuse of a powerful tool. Until recently, academic, independent clinical investigators were key players in design, patient recruitment, and data interpretation in clinical trials. The intellectual and working home of these investigators, the academic medical center, has been at the hub of this enterprise, and many institutions have developed complex infrastructures devoted to the design and conduct of clinical trials. The academic enterprise has been a critical part of the process that led to the introduction of many new treatments into medical practice and contributed to the quality, intellectual rigor, and impact of such clinical trials. But, as economic pressures mount, this may be a thing of the past. Many clinical trials are performed to facilitate regulatory approval of a device or drug rather than to test a specific novel scientific hypothesis. As trials have become more sophisticated and the margin of untreated disease harder to reach, there has been a great increase in the size of the trials and consequently in the costs of developing new drugs. It is estimated that the average cost of bringing a new drug to market in the United States is about $500 million. The pharmaceutical industry has recognized the need to control costs and has discovered that private nonacademic research groups—ie, contract research organizations (CROs)— can do the job for less money and with fewer hassles than academic investigators. Over the past few years CROs have received the lion’s share of clinical trial revenues. For example, in 2000 in the United States, CROs received 60% of the research grants from pharmaceutical companies, as compared with only 40% for academic trialists. As CROs and academic medical centers compete head to head for the opportunity to enroll patients in clinical trials, corporate sponsors have been able to dictate the terms of participation in the trial, terms that are not always in the best interests of academic investigators, the study participants, or the advancement of science generally. Investiga-