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Enrolling in a Study? Most Don't Ask Key Questions

May 22, 2004 - NEW YORK (Reuters Health) - A majority of people who enter clinical trials do so without knowing what questions to ask, and many don't understand the risks of study participation, a new survey confirms.

Ten percent of volunteers even said that they did not look at the informed consent form before signing it, according to survey results reported Wednesday by CenterWatch, a Boston-based publisher of clinical trials information.

The findings reinforce the belief that many patients, desperate for a cure, are entering clinical trials without having all the information they need to make a fully informed decision, CenterWatch noted.

It underscores "that volunteers need to become their own advocates and obtain more information before participating in a clinical trial," said Kenneth Getz, CEO of CenterWatch.

The survey, conducted in January and February of this year, involved 1,600 volunteers who had completed phase I, II or III clinical trials within the previous 6 months. In phase I trials, researchers are typically trying to determine if a treatment is safe, while later trials are designed to determine if the treatment actually works.

The findings suggest that volunteers may be giving their consent to participate in a trial without really understanding what they are getting into. Seventy percent didn't know what to ask at the outset of a trial, and 30% didn't understand that the study could carry additional risks.

Surprisingly, only 28% felt their overall experience would have been better if they had more discussions with study staff as part of the informed consent process.

"That 28% is a disappointingly low number given the 70% that said they knew very little or nothing coming into the informed consent process," Getz told Reuters Health.

Getz believes that patients are often "reluctant or anxious about asking too many questions." That's particularly true of senior citizens who are more trusting of research professionals and don't want to appear to be confrontational. Often, individuals are so scared and confused that they fear asking questions might delay their enrollment in a study, he added.

Patients' lack of true informed consent is troubling because it can raise their personal risk and the overall outcome of the trial, CenterWatch suggested. The company estimates that one out of 30 volunteers will experience a serious side effect and one in 10,000 will die.

On a positive note, the survey found that patients do have a clearer understanding of some aspects of the trial. Most understood the duration of the trial (85%), the number of visits required (84%), and the fact that they could terminate participation at any time (89%).

CenterWatch recently published a 300-page consumer guide describing the risks and benefits of volunteering for clinical trials. Copies of "Informed Consent: The Consumer's Guide to the Risks and Benefits of Volunteering for Clinical Trials" are available for purchase through www.centerwatch.com.

Separately, the American Association of Health Plans commissioned ECRI, an independent nonprofit research organization, to produce a patient reference guide and companion summary intended to demystify the clinical trials process. "Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness," may be downloaded for free at www.ecri.org and www.aahp.org.

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