On high-enrolling obesity trials, the site will do a "group consent" of 20 to 25 people simultaneously if the sponsoring company
approves. "When one person in the room asks a question, everyone benefits," said Vigliotti. "By the time we're done, they
all have excellent comprehension of the purpose of the trial and what's expected of them." Patients also have the opportunity
to ask questions privately regarding any personal matters. Those who are still interested in participating get sent home with
the consent forms to read again and come back with a new round of questions at their screening visit. "Enrollees who have
been group consented seem to have a somewhat better retention rate and reliably show up for study visits," Vigliotti added.
Before any trial begins, participants are reassured that they will be kept up to date regarding any amendments to the protocol,
including ones that don't directly impact them. "During a trial, Pivotal supplies participants with all available sponsor-produced,
IRB-approved press releases about the experimental compound—good or bad," said Vigliotti. "With increasing frequency, sponsors
have also been producing newsletters specifically for participants in their trials to improve communication." Pivotal always requests that sponsors provide treatment allocation information after a trial ends, says Vigliotti, and not
just to satisfy participants' curiosity: "It gives them the sense that they've come full circle with us...and gives us a great
way to continue building and establishing rapport with them." This type of follow-up gives former volunteers a sense of connection
to the clinical research enterprise. Vigliotti says she doesn't believe subject comprehension of consent documents is a significant problem because informed consent
is taken very seriously at Pivotal Research. But educating people about clinical trials can be tough, she said, when dealing
with first-timers who have never heard of an "adverse event" and don't understand the importance of reporting minor complaints
they perceive as unrelated to the study medication. This isn't the case everywhere. "I know of other coordinators at other sites who simply hand people a consent form, give them
15 minutes to read it, and have them sign it without prompting them for questions," said Vigliotti. "Those are also the cases
where patients are not as compliant." The educable moment There are numerous opportunities to improve the informed consent process. It is time, however, for clinical research professionals
to collectively act upon them. Recruitment and retention rates in North America and in Western Europe have been worsening,
as public distrust in the clinical research enterprise has increased. Fundamental and sustainable changes to the informed
consent process may hold an important key to building longer-term relationships with patients and, ultimately, with the public
as a whole. Kenneth A. Getz MBA, is a Senior Research Fellow at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, email: kenneth.getz@tufts.edu
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