Painting a pretty picture of clinical trials

Among the pharmaceutical industry challenges is that’s it hard to recruit patients for clinical trials. This is especially true in therapeutic areas such as oncology where there are lots of drugs in development and the need for clinical trial participants is high relative to the supply of patients. The Center for Information and Study on Clinical Research Participation (CISCRP), which is sponsored by a variety of clinical trial sponsors and research organizations, works to improve the public perception of clinical trials to increase the willingness of patients to participate. From the Drug Information Association’s Global Forum magazine:

“The ‘Medical Heroes’ campaign is designed to rebrand the clinical research industry,” explains Diane Simmons, CISCRP President and CEO. “We’re very clear on the level of public distrust in the clinical research enterprise — a really high level of distrust”

The magazine printed Patient Perspective, comprising five vignettes about “medical heroes,” aka patients who participated in clinical trials. To boil it down:

  1. Alexandra Scott got neuroblastoma as a baby. By age 3 1/2 chemo wasn’t working and she was told she was out of options. She participated in a trial and lived to be 8.
  2. Brennen Teel was diagnosed with acute lymphocytic leukemia at age 6. He entered a trial and was cured. Now he’s 27.
  3. Jean Burns got Parkinson’s at 51. She enrolled in a trial but the drug didn’t work and the trial was eventually halted. She’s not cured but she’s still a fan of trials.
  4. John Cleland had testicular cancer at 22. The cancer spread to his lungs. He entered a trial for cisplatin and was cured. Now he’s 58 and healthy.
  5. Barbara Holtz had invasive ductal carcinoma in 2001. She enrolled in a Herceptin trial –against the urgings of her family– and it worked great. She says, “The whole thing was a positive experience for me… My message to others would be, have an open mind to being a clinical trial subject. Learn all you can about the trial’s purpose and requirements and go for it!”

These are all nice stories. Note almost all are about cancer –and all of those results are either quite successful (#1) or extremely successful. The only trial that didn’t work is the Parkinson’s example –and hey Parkinson’s isn’t so bad anyway, right?

I think these stories are nice and I believe they’re true. But I am a bit concerned if CISCRP intends to present these results as representative of the patient experience in clinical trials, when the reality is much more mixed. Yes, many clinical trials are necessary and important, and those who participate are potentially generating benefits for other patients as well as the trial sponsors. But that really doesn’t mean that every patient should participate in a trial or that the results are likely to be dramatic.

May 28, 2009

5 thoughts on “Painting a pretty picture of clinical trials”

  1. Clinical trials are indeed not always a pretty picture and we want to thank David Williams for reminding CISCRP — and the clinical trials enterprise as a whole — that we must bend over backwards to ensure that a balanced perspective has been taken. It is only through this balance that the public will come to trust the information that they receive about the clinical research enterprise.

    CISCRP takes great pride in its many outreach and educational initiatives — print and electronic materials and its live, in-person meetings. We work very hard to present an objective, full picture — warts and all — in a language and format that is accessible and easy to understand. One of our primary mottos is ‘education before participation’ — emphasizing the importance of complete and balanced learning.

    This time — as David rightly points out — CISCRP didn’t look critically at these stories from the perspective of balance. As part of our new medical heroes awareness campaign, we chose to feature patients for their courage in making the profound decision to participate in a clinical trial. We erred on favoring their stories as medical heroes and not as educational examples of the risks and possible outcomes of participation in clinical research studies.

    Thank you again, David, and be on the lookout for upcoming patient profiles in the series that will better reflect a balanced view of volunteer courage with the risks and benefits of clinical trial participation.

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