By Deb Borfitz
September 21, 2009 | With the launch of its Clinical Research Learning Institute (CRLI) last year, the Parkinson’s Disease Foundation (PDF) became the nation’s second patient advocacy group actively seeking to integrate patients’ perspective into the clinical research process. One mission of the CRLI is equipping Parkinson’s disease (PD) patients to serve as clinical research liaisons within the PD community to counter low study participation rates, says Ronnie Todaro, PDF’s director of national programs. The other is to prepare them to serve on clinical research review and advisory boards and provide input to sponsors and investigators on trial design, implementation, and evaluation.
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| Ronnie Todaro |
PD patients include some very bright individuals with MBAs and PhDs who have more to contribute beyond serving as a study subject, says Todaro. Last July, 40 of them competed for the CRLI’s first 25 charitably funded training slots. Next month, an additional 40 from a field of 70 applicants will sit through the three-day training program. The educators are all “top-notch” researchers, bioethicists, and biostatisticians, mostly with the 125-site Parkinson’s Study Group collaborative.One year post-training, 80% of 2008 graduates were engaged in clinical research liaison activities, says Todaro. These include 40 community presentations to over 1,000 people with PD about clinical research participation; meetings with nine industry and 25 government representatives to share the patient viewpoint on PD clinical research; and contact with 125 media outlets. The group has collectively facilitated more than 160 inquiries about study participation that resulted in about 60 individuals enrolling in a PD clinical study. Additionally, one liaison is now training PD support group leaders across Michigan and another is serving on an institutional review board in Texas. At least two others are working directly with researchers to design more patient-friendly studies.
Ultimately, PDF hopes trainees will be able to connect with study sponsors via patient advisory councils that routinely present study designs to patients for review, says Todaro. “Sponsors would be surprised to learn what might and might not work in terms of logistics, reimbursement, and even their preferred pill size.”
Prerequisites for being a clinical research liaison are a diagnosis of PD and residence in either the U.S. or Puerto Rico, says Todaro. The selection process favors applicants who have previously participated in a clinical trial and demonstrated an inclination for community involvement. Ethnic and geographic diversity are also considerations. Applicants are selected by a planning committee comprised of CRLI graduates and others with PD as well as clinical trial researchers and coordinators. “It’s another wonderful opportunity for interaction between professionals and people with PD…outside of the clinical setting.”
Networking and information exchange is encouraged via an online portal developed specifically for program graduates, says Todaro. The portal provides opportunities for discussions, downloadable information for use during public presentations, and postings about the ongoing activities of liaisons. PDF also organizes monthly conference calls as a means of continuing education and to stay apprised of graduates’ work in the field. It doubles as an opportunity for the Foundation to get feedback about available therapies and concerns about the trial process, such as the frequent inability to get information once a study ends.
The idea for the training initiative emerged from a roundtable PDF organized in 2007 to examine ways to build trust in the clinical research process, says Todaro. A similar strategy, known as Project LEAD, utilized by the National Breast Cancer Coalition, was presented. The Coalition has criteria for engagement with sponsors, such as transparency of study results and creation of a patient advisory council. Currently, PDF has no formal sponsor requirements for working with the organization and graduates of CRLI.