Conflict of interest guidelines may have unintended consequences
CHICAGO–The patchwork quilt of conflict of interest guidelines may be unnecessarily intrusive and could have the unintended consequence of hindering valuable research, according to Robert M. Califf, MD. Since these structures are created by a multitude of organizations, the rules around conflict of interest are unclear and there is not agreement on the best way to proceed, Califf noted in a presentation at the American College of Cardiology (ACC) Scientific Sessions on Monday.

“I would argue that what we’ve done is take a critical societal issue that must work well and make it so burdensome and uncertain with so many penalties that our best and brightest are discouraged from participating,” he said. “It’s an aversion process for bright people that want to do research.”

Califf is uniquely positioned to speak on the issue of conflict of interest. He is the vice chancellor for clinical research and professor of medicine in the division of cardiology at Duke University Medical Center in Durham, N.C. The former director of the Duke Clinical Research Institute, one of the world's largest academic clinical research organizations, he became head of the Duke Translational Medicine Institute in 2006.

Califf has served as an editor for the first and second edition of the textbook, Acute Coronary Care, published by Mosby, and is the editor in chief of Mosby’s American Heart Journal. He is a section editor for the Textbook of Cardiovascular Medicine and has been an author or coauthor of more than 600 peer-reviewed journal articles.

As such, he has seen more than his share of conflict of interest guidelines.

“In the ideal world, the white knight investigator is interested only in the truth, with a totally unbiased view of how to conduct the best study, and how to achieve results in the fairest and most balanced way,” he said. “In the real world, human experimentation is a societal necessity that is dependent on thousands—if not millions—of human interactions with complex tradeoffs of what is best. The great uncertainty about the design, conduct, and interpretation of reporting clinical trials, including how much money has changed hands for a professional activity, is not in the service of the subjects in a clinical trial.”

Califf is not advocating doing away with conflict of interest guidelines. He strongly believes they serve a critical and important service in alerting reviewers to possible bias in the interpretation of study results. However, conflict of interest guidelines vary widely as to their implementation and reporting structure.

For example, the ACC and American Heart Association—two professional entities with seemingly the same goals—have similar conflict of interest guidelines but require investigators to fill out extensive reporting paperwork that is unique to each organization.

This is frustrating, time consuming, costly, and increasingly burdensome for scientific investigation, Califf noted. In addition, the penalties of prohibition from publishing research, as well as public approbation, from making an error on non-standardized conflict of interest paperwork can have a chilling effect on scientific investigators.

Rather than continuing with the Byzantine structure of a seemingly endless variance in guidelines generated by every professional and governmental entity, Califf argued for the adoption of standardized international guidelines and reporting for conflicts of interest for all clinical trials.

“I think we should be proud of the work we do and should have no inhibitions about publically disclosing (our sources of income and financial support for clinical trials),” he said. “I’m just making the plea that all the regulators (for conflict of interest) in different organizations get together and give us one form that we can fill out and keep up to date.”