To The Editor:

In the summer issue of the Harvard Public Health Review, Professor David Harrington of the Department of Biostatistics, commented on clinical trial conundrums. In that article he made the point that

Policymakers and the public almost take for granted that clinical trials are an essential part of the FDA's approval process for new drugs.

Yet the clinical trial still presents difficult, almost insolvable issues that arise due to the difference between them and other methodology used to study human populations. Not only is it a controlled experiment using human subjects, but a randomized clinical trial asked of the human subject something that would be unthinkable outside of the context of scientific study: to receive a treatment chosen neither by the subject, nor the caregiver, but instead by random assignment, the modern-day equivalent of the proverbial coin toss. As a result, the randomized clinical trial must stand up to special scrutiny.

Having been in the position of enrolling individuals in clinical trials, I have always felt considerable discomfort for several reasons, some of which arise from the very thoughts of David Harrington.

First and foremost is that the context of gaining participation in a clinical trial is subject to inadvertent, or sometimes deliberate, persuasion on the part of the person asking for the “informed consent.” It is exceedingly difficult to be perfectly neutral, particularly if one is at the same time the physician for the patient.

Part of the problem, I think, is in the use of the word “consent.” In the case of appendicitis, I would willingly give my consent to a surgeon to remove my appendix. On the other hand, the word consent implies that I think it is a good thing to do and I want you to agree with me. I think it is sometimes very difficult for a patient to disagree with the physician about anything, and the word itself may be the culprit.

My suggestion would be that we change our language and in the case of clinical trials, ask for “informed choice.” The difference may seem subtle; on the other hand, it is clear that “consent” has the notion of agreement with the person asking the favor, and “choice” has a more neutral connotation.

I'm not looking for a new set of forms to fill out (we surely have enough), but one could devise a very simple statement that would hold up as evidence that consideration was given to the rights of the patient.

Mary Ellen Avery