Years ago, most drug trials were conducted in academic settings. This is no longer the case. Today, the majority of "clinical trials" investigating the efficacy and safety of new drugs are conducted by physicians practicing in the community. Pharmaceutical companies apparently find that community doctors are better able to meet recruitment goals in a timely manner and at lower cost than academic physicians.
Some community doctors do not enroll their own patients in such studies; rather, they enroll patients referred to them from other doctors or recruited through advertising. However, other community physicians do enroll their own patients. In these situations, the doctor has dual responsibilities - care provider and research physician, responsibilities that can sometimes have inherent conflicts.
Some complex illnesses require treatment by highly trained subspecialists. It can be argued that drug studies involving these illnesses benefit from such specialists enrolling their own patients with the illness under study because of the high degree of expertise required for the diagnosis and management of such patients.
However, many pharmaceutical studies involve common disorders such as high blood pressure, diabetes, high cholesterol, or depression. In such cases, do conflicts of interest arise when physicians enroll their own patients in drug studies that they are conducting?
Here are a few of our concerns:
Drug companies pay doctors for each patient enrolled in a drug trial. Can the doctor's judgment about a diagnosis or need for a particular treatment be influenced by a desire to enroll patients in a study? Although some illnesses require objective laboratory evidence for diagnosis, others (for example, all psychiatric disorders) are diagnosed based on criteria that have some ambiguity and often allow wiggle room in determining whether a symptom is present or absent.
If the doctor doing the study observes that a patient/participant is having potentially serious side effects that may be caused by the experimental drug, will that doctor be as willing to recommend that the patient drop out of the trial as he or she would be if not involved in the drug study?
Does the doctor have sufficient expertise to treat the condition being studied? For instance, if a primary care doctor is participating in a study of depression, does he or she routinely diagnose and treat depression?
If your doctor asks you to be in a trial that he or she is conducting, is it awkward to say "thanks, but no thanks"? Would you fear upsetting your doctor by saying "no" to a drug trial? Would you be comfortable asking your doctor how much money he or she receives for your participation in the trial? Should your doctor tell you this? Should your doctor tell you about his or her relationship with the company in question, including total compensation from company sources?
Do some patients get the impression that they would get better care from their doctors if they participated in a drug trial?
On the other hand, are there potential advantages for patients to participate in drug studies that their own doctors are conducting? Some might argue that doctors often have longstanding relationships with their patients and wouldn't suggest participating in a drug study unless they thought it was in a patient's best interests. Also, since doctors know their own patients well, is it possible that they are more likely to recognize side effects and to recommend that a patient/participant drop out of a study if side effects occur?
Many of these questions are difficult to answer, and the answers likely differ depending on the patient, the doctor, and the relationship between the two.
In general, we believe that it is advisable to separate clinical treatment by a patient's personal physician from treatment occurring as part of a drug study. When significant potential for conflicts of interest can easily be avoided, why not avoid them? If your doctor thinks you might qualify for a drug study that one of his colleagues is conducting, why not consider participating in the drug study by the colleague and have the added advantage of knowing that your own physician is looking out for you without concerns that there are financial issues that may be influencing the clinical judgment of your doctor. This, of course, assumes that your doctor is not in a financial relationship with the doctor doing the study and that your doctor is not receiving a referral fee.
We strongly believe in the need to advance knowledge through research. Basic science research, clinical research, and clinical trials are all important contributors to the development of new and more effective treatments in all areas of medicine. Many patients are altruistic and want to help by participating in such research. This is admirable and essential. However, we want to encourage each individual to be aware of the issues we have raised and to have direct and frank discussions with the study physician, especially if that physician is also the person's care provider.
This column was co-written by Eugene Rubin MD, PhD and Charles Zorumski MD.