Enrolling in a Study? Most Don't Ask Key Questions
Wed May 22, 5:51 PM ET
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
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
"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
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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