Pro & con.(Opinion)(Interview)

Should patients be required to take part in comparative clinical trials?

YES Although some studies raise the concern of whether patients are put at too much risk, we must also ask if research safeguards are sometimes overly protective of people who might enter clinical trials. As I wrote in the September-October Hastings Center Report, there are many medical problems for which physicians can choose among multiple therapeutic options, and the decision is typically based more on hunch than on data. Patients would benefit greatly from studies that clarify the benefits and risks of different options for their illnesses.

However, these studies are delayed by difficulties in securing the participation of enough individuals. For instance, in one study comparing the two leading therapies for chronic atrial fibrillation, only 55% of patients invited to enroll in the study agreed to do so.

Given the difficulties in enrolling patients, physicians should be able to make access to treatment they provide contingent on the patient's willingness to enter a clinical trial, when the trial compares two or more accepted therapies to determine if one is superior. Patients would not be subjected to any risk by their participation--they would be receiving treatment that, under current knowledge, is as good as the alternatives--and they would be free to decline participation and receive care from another physician. Of course, patients should not be required to take part in trials of experimental therapies; such a requirement would be unethical.

Some people are concerned that making treatment dependent on clinical trial participation would undermine the patient's trust in the physician. This concern shouldn't lead us to reject the idea entirely. Past abuses of clinical trials have involved either lack of informed consent or an unacceptable risk to patient health, neither of which we are talking about here.

Some people may also worry that patients will feel pressured to enroll in the study. But if they agree to participate, they will not be placed at any greater risk than if they decline. And importantly, they can always decline participation and receive their preferred care from another physician. Moreover, the purpose of the pressure is to encourage patients to help doctors understand and treat disease. There is nothing wrong with reasonable efforts at persuasion that will foster socially desirable behavior.

NO As a physician who has conducted clinical trials, I've found ...