By Deborah Borfitz
July 21, 2008 | Investigators and potential patients in the U.S. say they’re interested in clinical research, but referral and enrollment patterns often do not bear that out. Can this seemingly “losing proposition” in subject recruitment be overcome?
This was one of the intriguing topics of discussion last month at the Drug Information Association’s 44th Annual Meeting in Boston*. Contributing to the dialogue were Matthew Kibby, global operations leader at BBK Worldwide; David S. Zuckerman, president of Customized Improvement Strategies LLC; and Kenneth Getz, senior research fellow at Tufts University’s Center for the Study of Drug Development and chairman of the non-profit Center for Information and Study on Clinical Research Participation (CISCRP).
All three had concrete suggestions for improving U.S. patient enrollment statistics, which Zuckerman views primarily as a “symptom” of other trial-related problems such as poorly written protocols and a haphazard approach to site selection. Enrollment is less of an issue for companies when they look at recruitment “holistically,” he said.
Getz agreed, suggesting the recruitment problem may in fact be a reflection of unrealistic timelines or a protocol that’s unfeasible. He noted that 70 to 80 percent of AIDS and pediatric cancer patients participate in clinical trials regularly, but recruitment and retention rates overall have never been lower. Close to one billion in marketing dollars will be spent trying to improve the situation.
Kibby declined to blame protocols, given same-study enrollment figures are far better in other countries. The U.S. gets sites up and running four times faster than places like China and Brazil, he said, putting it “in the best position to do something about [low enrollment].”
Site selection could be improved by focusing on “last patient out” rather than “first patient in” so decisions are driven by knowledge, not the clock, said Zuckerman. More systematic, upfront planning could “easily” double the overall enrollment rate from 5 to 10 percent.
It’s a matter of evaluating “who’s going to be a champion of your study, in addition to the business factors,” said Kibby. Site surveys also neglect to ask about the experience of the study coordinator.
Identifying high-enrolling sites is a crapshoot “because of the commoditized way sponsors view and approach their relationship with sites,” said Getz. “The sites see no loyalty or continuity, so they’re scrambling from one trial to the next, often being handed protocols they really shouldn’t be doing.” Site performance might be enhanced if sponsors and clinical research organizations treated sites as “strategic assets,” rather than asking them to bid on unfinished protocols or to repeatedly sit through the same RFP process.
Kibby said sites need help recruiting more efficiently, including identifying and consenting patients. Money won’t necessarily buy “greater recruitment acumen,” and it may create ethical issues.
What’s needed is “more prudent allocation of dollars we’re already spending” to include building and repairing public trust in the clinical trials enterprise, said Getz. “One area of increasing concern to me is the general lack of appreciation for the gift people make when they participate in a clinical trial. This has been going on unanswered by industry for a decade.”
Pop culture depicts study volunteers as people “willing to gamble with their lives, take a risk with professionals who can’t be trusted, [and] who are motivated by greed and corruption,” said Getz. “I see a huge need to correct that perception.”
_________________
44th Annual DIA Meeting, June 22-26, 2008, Boston.
________________________________
This story first appeared in eCliniqua,one of Bio-IT World’s free e-newsletters. Subscribe here.