By Deb Borfitz
April 20, 2009 | Serious discussions are finally underway about how to overcome the many obstacles to clinical trial recruitment. One of the latest, a “Quest for Consensus” patient recruitment conference sponsored by Fleishman-Hillard Clinical Trials Division last month, elicited some novel solutions to the three primary challenges identified by attendees: repeated failed behaviors by study sponsors, complex and unrealistic study protocols, and flawed study site feasibility assessments.
The invite list was limited to a small group to ensure the Philadelphia conference was interactive and collaborative, says senior VP and partner, John McAnulty. Participants included 25 large pharmaceutical and biotechnology companies and niche providers.
One of the fresh ideas that surfaced was for sponsors to employ monitors dedicated to patient recruitment to educate and assist study sites. The group unanimously agreed that traditional clinical research associates are overburdened and not always properly trained for the responsibility.
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| John McAnulty |
Another proposed solution to fixing ineffective processes at the sponsor level is to “establish and remain committed to dedicated departments” for patient recruitment planning and execution, says McAnulty. A third is to incorporate strong educational recruitment program discussions into investigator/coordinator meetings as well as hold meetings dedicated to patient recruitment at the beginning of a study and again six to 12 months later.The most original idea that emerged for simplifying complex protocols is to determine via focus groups and online surveys if potential volunteers are willing to participate in a study based on factors such as the planned eligibility criteria, number of site visits, and required medical tests.
Another suggestion, already being successfully applied by some companies, is to conduct simulations of the actual operations against the protocol at a sampling of study sites, to avoid unrealistic procedure scheduling or timeframes and ensure the required study procedures can be performed at those sites. Strategic planning also needs to happen earlier, the group decided, to ensure study timelines are realistic.
An industry-sponsored, shared database of information about the past performance of study sites was the highlight of discussions about how to remedy a faulty site selection process, says McAnulty. Precisely how that will happen and how long it will take remain open questions, but the sponsors in attendance were “all willing to share their experience.”
McAnulty adds, “There was a lot of discussion about how industry doesn’t…press [sites] to provide a realistic projection of the number of patients they will be able to recruit within their practice.” Face-to-face study site assessments provide a better perspective on potential site issues than standard site feasibility questionnaires, attendees agreed. Internet-based tools, questionnaires, and processes could also more easily identify unsuitable sites.
Site feasibility and recruitment planning are considered critical to recruitment success by high-level pharmaceutical executives who attended the international Patient Recruitment and Retention conference in February in Amsterdam. The group additionally recommends that study coordinators be tangibly recognized for their performance.
A variety of recruitment strategies were discussed at that conference, chaired by MediciGlobal for the Allan Lloyds Group. These range from community presentations by doctors to patient groups in Germany to the use of the Internet in France and Belgium, with an overall view that patient advocacy and social marketing are emerging.