New policy on disclosure of interest for American College of Rheumatology Journals.

The publication of original research is the cornerstone of scientific inquiry and the advancement of new ideas and knowledge. Indeed, one of the reasons for the amazing progress in biomedicine in the past century is the openness of science and the ever-increasing speed with which information can be disseminated to other investigators who can confirm, extend, and sometimes refute the earlier findings in a self-cleansing and selfcorrecting process. Scientific research does not occur in a vacuum, however, as many advances have broad impact for society as well as for individuals. Critical decisions about patient care, health care spending, public policy, national research priorities, and individual career choices can all be strongly influenced by scientific publication. In view of the wide ramifications of scientific research, data must therefore be collected, interpreted, and reported as objectively and accurately as possible. In the past, biomedical research was typically performed by independent investigators or small groups of investigators at academic centers with funding from sources that did not have a direct interest in the specific outcome of any study. With the explosive growth of “big science” and the pressure for the rapid development of new treatments, the conduct of research has changed and its complexity has increased. In various and sometimes unexpected ways, investigators, their institutions, and funding sources may all have a stake in the success of a study in a manner that transcends the acquisition of new knowledge (1–3). While the potential for conflicts of interest may exist at multiple levels, financial gain is an area of major concern (4), especially in cases where authors or sponsors of studies may benefit significantly from patents or from the approval of new therapies or technologies. Clinical trials that are sponsored by industry have raised the most serious and vexing questions about the potential for conflict of interest. These trials are essential to drug development and approval. Although the goal of such studies is improved patient care, the gains associated with a particular outcome are potentially great, and can accrue to the investigators performing the study as well as to the sponsoring company. For investigators, in addition to the satisfaction of contributing to important research, more tangible benefits may be realized. These benefits may include financial remuneration, enhanced reputation, increased referrals, and academic promotion. For the company, the outcome of the study can determine profitability and survival. For trials on new drugs, the economic and logistical realities make pharmaceutical firms almost the only funding source. To demonstrate clear results and improvement over existing agents (in either increased efficacy or reduced toxicity), clinical trials often include very large patient numbers and organizational structures of daunting size and complexity. Multiple investigators, teams, and centers must cooperate in a matrix structure that incorporates a broad array of talents and skills and operates quickly and efficiently. In this type of structure, the role of investigators, in either academia or practice, can be limited and concerned predominantly with patient recruitment and evaluation. Correspondingly, companies often play a major role in the assembly and analysis of data for presentation in journals and at meetings. Thus, authors from outside the company may play a very different role from that in a traditional scientific article, where they are decisive in study design, data analysis, and manuscript preparation. In 2001, the International Committee of Medical Journal Editors (ICMJE) published a document outlinDavid S. Pisetsky, MD, PhD: Durham VAMC and Duke University Medical Center, Durham, North Carolina, Editor, Arthritis & Rheumatism; Gene G. Hunder, MD: Mayo Clinic, Rochester, Minnesota, Editor, Arthritis Care & Research; Ellen M. Gravallese, MD: Harvard Institutes of Medicine, Boston, Massachusetts, Chair, American College of Rheumatology Committee on Journal Publications. Address correspondence and reprint requests to American College of Rheumatology, 1800 Century Place, Suite 250, Atlanta, GA 30345. Submitted for publication January 22, 2003; accepted January 22, 2003.