As research has moved away from the realm of universities and into the private sector, more physicians are being paid by drug companies to enroll and monitor patients during clinical trials. Private corporations have been the largest sponsors of pharmaceutical research in both Canada and the United Sates in the last twenty years.

Research Ethics Boards (REB’s) exist to protect the safety of research subjects. However, they provide guidelines only, and often guidelines are ambiguous. REB’s may be private entities, and thus may be vulnerable to pressure.

Some of the concerns raised in regards to physician remuneration question whether physicians can maintain objectivity. Physicians may not fully disclose all potential risk factors to patients if it is in their financial interest to recruit subjects for a trial. Another concern is the potential for breech of confidentiality. A breech could occur if physicians actively search for likely candidates for a drug trial by accessing charts of patients who are not theirs. Physicians may also be tempted to enroll patients in a trial who do not meet the criteria for selection, or patients who are “on the cusp.”

Patients may also feel some pressure to agree to enroll in a study strictly because of the nature of the physician-patient relationship. Patients place great trust in their doctors, but they may be afraid that refusing to take part in a study may cause their doctor to have negative feelings towards them. They may agree to take part simply to keep their doctor “happy.”

Another concern is that financial inducements may hamper physician’s decision-making. For example, a doctor who was being rewarded financially for every patient who completed the study might be inclined to keep a patient in the study even if they suffered untoward symptoms.

There are internationally developed guidelines that are meant to provide guidelines in clinical research; some examples are the Helsinki Declaration, International Guidelines for Biomedical Research Involving Human Subjects, and Good Clinical Practice for Trials on Pharmaceutical Products (World Health Organization).

What are some considerations that can mitigate some of the aforementioned conflicts of interest? Above all, patients should be made aware of any potential conflict of interest and also have the right to know exactly how the physicians are being rewarded by the drug company. Additionally, patient confidentiality should be protected as much as possible and patients should be made aware of how information about them may be shared. In this way, physicians can participate in research trials without compromising patient trust and safety.

Reference

Puttagunta, P., Caufield, T., Grenier, G. (2001). Conflict of Interest in Clinical Research: Direct Payment to the Investigators for Finding Human Subjects and Health Information. Health Law Review, 10(2)