Lisa Henderson
|
I've been thinking a lot about "the people" lately. Maybe it's the election. Or in regard to clinical trials, maybe the
abundance of patient recruitment methods in the news has me thinking about people. The methods to find patients who become
subjects in a study are many. A general flight overseas to find large numbers of treatment naive patients. Large databases
of information on physicians and the therapeutic categories of patients they see determined by claims data. Software modeling
that enables CROs and sponsors to use past data to predict the future performance of sites in regard to subject enrollment.
All are important strategies toward finding the necessary people to become subjects in a trial.
However, once you find the patient, the patient has to agree to become a subject in the actual clinical trial. And that, to
me, may be a harder nut to crack than finding the patient.
In last month's Clinical Insights column, Ken Getz discussed the lack of trust the general public has in the clinical research
industry. Supported by numerous consumer polls, the pervasive feeling is that the pharmaceutical industry as a whole, with
its lack of faith in the government's ability to oversee the drug development process, is negatively impacting the clinical
research process. To me, it appears a perpetual cycle: If faith in the process is not restored, companies will need to develop
ever-increasingly complex ways to find potential patients. That may not be a bad thing for entrepreneurs and organizations
developing the sophisticated models needed to reach the right potential patient pools. One may happen upon a process that
will revolutionize the way subject recruitment is conducted for the better. But you still need the people to agree to participate
in the drug trial.
As Getz observes, there have been regulatory and internal industry reforms to help rebuild this trust, including the Web-based
clinical trial listings registries. And as Getz noted, along with these initiatives education and outreach are important tools
to improving public trust. Education allows people the opportunity to make better informed choices for themselves. If people learn in their education
process that all drugs carry risks, even aspirin, then they are still making a better informed choice. When they learn about
drug safety measures in place to protect them, they can make informed decisions again. Whenever the whole story has not been
told and information has not been willingly forthcoming, or even has the appearance of secrecy, as with drug safety issues,
it erodes trust. And it is harder to regain that trust once lost. It will be harder to enroll patients to become subjects
if they don't trust the process.
In what may be only the beginning of more industry efforts to help educate the public on the clinical research process, and
regain public confidence, the Association of Clinical Research Professionals last month devoted its members-only publication
to the topic "Measuring Trust in Clinical Research" at http:// http://www.acrpnet.org/TheMonitor/September/ 2008. The issue will be available to view online indefinitely for all.
Lisa Henderson
Editor-in-Chief
email: lhenderson@advanstar.com
http://www.appliedclinicaltrialsonline.com/
