Managing Conflicts of Interest in the Conduct of Clinical Trials

Abstract

The interaction between medical research and for-profit corporations is not new, but it has expanded considerably in recent years. Some of the recent trends may accelerate the research process, particularly when large clinical trials are required. However, a renewed commitment to the application of high ethical standards is essential to ensure that societal trust in research is not eroded, subjects enrolled in trials do not become merely a means to an end, and medical research is efficiently translated into clinical advances that will benefit future patients. This article focuses on the analysis of conflicts of interest in the conduct of clinical trials in both academic and community-based settings. Specifically, it discusses how the roles of research scientists and clinical practitioners differ and the importance of ensuring that participants' consent to enroll in clinical trials is not the result of confusion about the goals of an experimental treatment that may resemble clinical care. The article also discusses the potential conflicts of interest that can arise when clinicians stand to gain from enrolling their own patients as subjects in clinical trials and examines various instances in which disclosure of information regarding funding and compensation may serve to minimize such conflicts. This article emphasizes that to preserve the integrity of research and to protect the welfare of human subjects who enroll in trials, physicians should have adequate training in the conduct of research and be familiar with the ethics of research. When a physician has treated or continues to treat a patient who is eligible to enroll as a subject in a clinical trial conducted by the same physician, someone other than the treating physician should obtain the participant's informed consent. Finally, the article addresses disclosure of financial incentives and related funding issues.

Industry-sponsored economic studies in oncology vs studies sponsored by nonprofit organisations

“…In conclusion, our results suggest that there is a greater probability that industry-sponsored economic studies in the field of oncology tend to be costminimisation analyses, to investigate less likely diagnostic screening methods, and to draw positive qualitative conclusions about costs, as compared to studies supported by nonprofit organisations. There has long been discussion as to whether commercial sponsorship of clinical studies produces a conflict of interests (Davidson, 1986;Rochon et al, 1994;Krimsky and Rothenberg, 1998;Smith, 1998;Stelfox et al, 1998;Montaner et al, 2001;Morin et al, 2002). However, only two applied studies deal with this issue for health economic studies conducted in the field of oncology.…”

“…There has long been discussion as to whether commercial sponsorship of clinical studies produces a conflict of interests (Davidson, 1986;Rochon et al, 1994;Krimsky and Rothenberg, 1998;Smith, 1998;Stelfox et al, 1998;Montaner et al, 2001;Morin et al, 2002). However, only two applied studies deal with this issue for health economic studies conducted in the field of oncology.…”

Research ethics - revisited

“…Pharmaceutical companies expect the time between research and development and the market to be shortened. According to some estimates, spending in research and development during the past 10 years in the 20 biggest US drug companies is likely to be 4 times the expected increase in sales in the next 10 years (11,12). Despite such prognoses, the drugs industry in the US is still experiencing increasing profits compared with other industries (13).…”

“…Commercial research institutions increasingly contribute towards the documentation of drugs and medical technology to the detriment of academic institutions. During the period 1991Á/1998 in the USA, the share of industry allocations granted to academic institutions declined from 90% to 40% (11,12). In the Nordic countries and in the European Union, public research funding encourages cooperation with industry.…”

“…Non-publication of unfavourable results; inappropriate coercion aimed at altering information in medical research papers; ''ghost-authorship'' where industry-affiliated writers who lack knowledge of the data exploit the name of prominent researchers who appear as authors; evidence how research funding is influenced by the likelihood of a certain therapy being recommended, are all current examples that have been documented (11,12,14). Academic institutions have recognised that they need guidelines for cooperation with the private sector (15).…”