Fw: Enrolling in a clinical trial?

>> Enrolling in a study? Most don't ask key questions
>>
>> May 22, 2002
>>
>> 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.
>>
>>