Wednesday, March 16, 2011

Realistic Optimism in Clinical Trials

The concept of “unrealistic optimism” among clinical trial participants has gotten a fair bit of press lately, mostly due to a small study published in IRB: Ethics and Human Research. (I should stress the smallness of the study: it was a survey given to 72 blood cancer patients. This is worth noting in light of the slightly-bizarre Medscape headline that optimism “plagues” clinical trials.)

I was therefore happy to see this article reporting out of the Society for Surgical Oncology. In looking at breast cancer outcomes between surgical oncologists and general surgeons, the authors appear to have found that most of the beneficial outcomes among patients treated by surgical oncologist can be ascribed to clinical trial participation. Some major findings:
  • 56% of patients treated by a surgical oncologist participated in a trial, versus only 7% of those treated by a general surgeon
  • Clinical trial patients had significantly longer median follow-up than non-participants (44.6 months vs. 38.5 months)
  • Most importantly, clinical trial patients had significantly improved overall survival at 5 years than non-participants (31% vs. 26%)

Of course, the study reported on in the IRB article did not compare non-trial participants’ attitudes, so these aren’t necessarily contradictory results. However, I suspect that the message of “clinical trial participation” entails “better follow-up” entails “improved outcomes” will not get the same eye-catching headline in Medscape. Which is a shame, since we already have enough negative press about clinical trials out there.

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