Sponsorship, authorship, and accountability.

Abstract

The editors of wjm along with editors of other general medical journals recognize that the publication of clinical findings in respected peer-reviewed journals is the ultimate basis for most treatment decisions. Public discussion about this published evidence of efficacy and safety rests on the assumption that clinical data have been gathered and are presented in an objective and dispassionate manner. This discussion is vital to the 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 clinical research is conceived, study subjects are recruited, and the data analyzed and reported (or not reported) may threaten this precious objectivity. Until recently, academic, independent clinical investigators were the 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.1,2 But as economic pressures mount, this may be a thing of the past. As trials have become more sophisticated and the margin of untreated disease harder to reach, the size of the trials and, consequently, the costs of developing new drugs have greatly increased. It is estimated that the average cost of bringing a new drug to market in the United States is about $500 million.3 The pharmaceutical industry has recognized the need to control costs and has discovered that private non-academic 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, compared with only 40% for academic trialists.1 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.4 Investigators may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation. These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will. And, unfortunately, even when an investigator has had substantial input into trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavorable to the sponsor's product. Such issues are not theoretical. A number of recent examples of such problems have been made public, and we suspect that many more go unreported.5,6 We strongly oppose contractual agreements that deny investigators the right to examine the data independently or to submit a manuscript for publication without first obtaining the consent of the sponsor. Such arrangements not only erode the fabric of intellectual inquiry that has fostered so much high-quality clinical research, but also make medical journals party to potential misrepresentation because the published article may not reveal the extent to which the authors were powerless to control the conduct of a study that bears their names. The section on publication ethics in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication, a document developed by the International Committee of Medical Journal Editors (ICMJE) and widely used by individual journals as the basis for editorial policy, has been fully revised. The revised section may be found linked to this article on our web site (www.ewjm.com).