Ethics and industry-sponsored research

Although we agree with the publication rules suggested by Frank Davidoff and his colleagues in the International Committee of Medical Journal Editors,1 we think the implementation of the proposals of Steven Lewis and coauthors2 would seriously impair the conduct in Canada of academically credible clinical research carried out in partnership with industry. The examples cited by Lewis and colleagues are all warnings to investigators that companies are primarily responsible to their stockholders, but only one, the Olivieri case, relates to a dispute over the publication of results.2

Our experience in coordinating over 120 national clinical trials in which pharmaceutical companies supplied drugs or financial support or both suggests strongly that such untenable situations can be avoided if the principles identified by Davidoff and colleagues are contractually protected. In all of our trials we, or a partner academic group, create and maintain the trial database, analyze the trial data according to protocol-specified plans and have the right to publish our conclusions. Our host university insists on preserving these academic rights. Furthermore, we are ultimately accountable for all of our studies, whether supported by industry or by competitive grants, to the National Cancer Institute of Canada, which periodically peer reviews the scientific quality of our program and the trials we conduct.

By focusing on a few justly disturbing cases and not examining alternative models, Lewis and colleagues failed to gather the data needed to make sound recommendations.2 At a time when the major source of new therapeutic agents is the pharmaceutical industry, we need solutions that protect academic integrity but simultaneously allow Canadian trials to be developed and conducted quickly by qualified physician-investigators. The highly centralized and potentially bureaucratic system proposed by Lewis and colleagues might fulfill the former requirement but will certainly not fulfill the latter.

We feel strongly that better approaches must be adopted if Canadian investigators are to be adequately protected in, but not excluded from, an important research endeavour. Our experience suggests that the key elements of such approaches should include accountability to an agency that represents the public interest and a clear understanding on the part of investigators and university contract officers of their rights and responsibilities. All of this can be achieved by educational initiatives and appropriate leadership from existing professional and funding bodies.