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“Unrealistic optimism” and participation in early-stage clinical trials

Posted Mar 03 2011 12:00am

There is an excellent article by Pauline Chen in today’s New York Times. It is focused on the mindsets of patients who willingly participate in the very earliest clinical trials of  new drugs for the treatment of cancer, and on ethical issues related to enrollment of patients into these trials.

Phase I (and some Phase II) clinical trials are almost never about the effectiveness of a new cancer therapy. They are entirely focused on identifying the potential for toxicity and the maximum safe doses of the drug that can be given to sick patients. It is fair to say that few of the patients who are enrolled really benefit significantly from participation in these very early-stage trials perhaps no more than about 5 percent.

In her article , Chen discusses a recent research study by Jansen et al. that appears in the highly specialized journal IRB: Ethics and Human Research.

Between August 2008 and October 2009, Jansen and her colleagues asked 70 patients enrolled in several early-phase cancer trials at a  about their expectations and understanding of the trials they had agreed to take part in. It is clear that a significant majority of these patients fully appreciated that the goal was to advance research, not to treat them. However, the patients also tended to demonstrate what the research team described as “unrealistic optimism” with respect to their personal expectations about the trial outcome for them as individuals. Most of the trial participants believed that they were different, that the new drugs would work for them, and that they would just “do better” than the average patient in their trial.

There are all sorts of interesting and important ethical challenges associated with this issue. But it is also worth remembering that the sort of person who is willing to participate in such early stage trials tends, already, to be unusual. Such patients have commonly, previously, participated in one or more other trials. Many have a “glass half full” mentality about life and are willing (rightly or wrongly) to try pretty much anything to extend their lives because of how much value they place on another week with their children or a desire to see a grandchild graduate from high school.

If you have ever participated in a clinical trial yourself, or you have been thinking about it particularly if it is a very early stage trial of a completely new drug Dr. Chen’s article is well worth reading.

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