A patient volunteers to participate in a drug research project which is related to the patient’s own illness. The question is: why would the patient want to participate? An obvious answer might be that the patient is motivated about the possibility that the new drug will benefit recovery or management of the illness better than the drugs which the patient has been prescribed. The patient may believe that he or she will, in the study, will have access to the new drug. This thinking and believing really represents a misconception. It is based on the patient’s conception, which may be fostered by inadequate or misleading information about the study, that sufficient benefit to the patient’s illness will be the result of participation in a clinical trial that will trump any of the risks of the study. This is the “therapeutic misconception”, a term invented by Roth, Appelbaum and Lidz some 25 years ago, regarding patient involvement in clinical research.
What is the misconception? Well, first might be the patient considers him/herself as a patient in the study. Many studies are designed not to treat the volunteer with the appropriate illness as a patient but to consider the volunteer as a experimental subject. Yes, in the United States there are overseeing governmental mechanisms in clinical research attempting to protect the human volunteers as human subjects but not necessarily as patients. Being attended to as a patient demands that the professional keep only the best interests of that patient in the decision making. But, in clinical research, the goal is to attend to the best interests of the research study. For example, toxic effects of drugs on the volunteers are generally monitored and if the risk to the volunteers, through statistical monitoring, becomes greater than initially anticipated, the study is stopped. Well, one would agree with that kind of interest in the study subject. But sometimes, if the beneficial results of the drug study are strongly positive, and this is also monitored, then the study also may be stopped to conserve the costs but perhaps only to the detriment of the patient whose illness was improving with the drug under study. There, unlike in usual medical practice, benefit for the patient is ignored. A complicating issue in this conflict of benefits is when the patient’s physician is also a member of the research team (a topic which I covered on this blog in February 2005 as “Wearing Two Hats: Clinician and Researcher”). How can the physician resolve the conflicting responsibilities?
Another misconception is that the patient will receive a drug in the study which could be to the patient’s benefit. The basis of a true clinical research random controlled study is not to study the known but to study the unknown and undetermined.
Read it all here.