objectivity—consciously or unconsciously—and so widen the opportunities for misleading research results. And even when objectivity is preserved, the public recognition of such potential conflicts of interest may erode confidence in biomedical research.2
The substance of these concerns is illustrated in the recent controversy surrounding several investigators who conducted research supporting the wide indications for an ophthalmic ointment while owning large amounts of the manufacturer's stock.3,4,5 Later research by different investigators challenged the original findings.6,7 Attempts to address these problems have recognized the need to balance the potential for misguided research with the legitimate social goals underlying economic incentives. The many advantages to these economic incentives have been extensively discussed elsewhere. Links between investigators and for-profit concerns create efficiencies not only in the conduct of research, but also in the commercialization and distribution of the products of research. In part because of this continuum between efficiency and conflict, conflict of interest in this setting has defied simple definition.8 There is, nevertheless, widespread consensus that conflicts of interest by any definition need attention from within the biomedical research community. The past few years have seen statements by federal funding agencies,9 universities,10 scientific journals,11 professional organizations,8 ,12 ,13,14 and individual research teams.15
None of these statements, however, distinguishes among various types of biomedical research or among the differences in research goals or methods that may encourage or deter conflicts of interest for investigators. One relatively new form of medical research uses somewhat nontraditional research methods to compare and evaluate the effectiveness of different medical practices in achieving desired patient outcomes. These projects are supported by the Agency for Health Care Policy and Research (formerly the National Center for Health Services Research) under their Medical Treatment Effectiveness Program. Research is conducted by multidisciplinary Patient Outcomes Research Teams (PORTs) using novel methodologies that span a wide area of expertise. The methodologies employed by PORTs are novel enough, and the intensity of their projects are deep enough, to raise concerns that the existing guidelines on conflicts of interest need to be expanded.
This paper introduces principles of outcomes research and examines ways in which members of PORTs may be at risk for conflicts of interest different from those faced by more traditional clinical researchers.