More MS news articles for May 2002

Clinical Trial Volunteers Fail to Ask Key Questions

http://www.medscape.com/viewarticle/433975

May 21, 2002
NEW YORK (Reuters Health)

A majority of individuals who enter clinical trials do so without knowing what questions to ask, and many do not understand the additional research risks that participating in a trial may pose, a new survey confirms.

Ten percent of volunteers even admitted that they did not review the informed consent form before signing it, according to survey results reported today 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 six months.

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.

The survey also found that just 18% percent consented to the trial without getting input from their personal physician, nurse, family member or another trusted individual.

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. Large majorities 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%).

Clearly, research professionals play an important role in helping patients understand the trial, but reviewing the consent form is only part of it, Getz noted. Patients also need to know things that researchers may not discuss, such as the role that institutional review boards play and how patients can choose the most suitable trial for them.

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. Getz said the book approaches the topic as a journalist would. He said it even includes a history of clinical trials' most egregious or fraudulent activities.

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 http://www.ecri.org and http://www.aahp.org.
 

© 2002 Reuters Ltd