Eli Lilly is one of the first companies to help fund a campaign that thanks clinical trial participants for their "heroism."
At a time when pipelines are drying, approvals are taking longer, and the total cost of bringing a drug to market is skimming the billion-dollar mark, drug companies are struggling to find ways to reduce the time, expense, and risk of the R&D process. But they're being stymied before they even begin, with four out of five clinical trials delayed because sponsors can't enroll enough eligible volunteers. Spending on recruitment now costs the industry about $500 million each year.
The problem, according to the Center for Information and Study on Clinical Research Participation (CISCRP), is that Americans don't believe that participating in a trial is a noble thing to do. When the group asked 1,000 people to identify who makes the "greatest contribution to mankind"--among an organ donor, blood donor, marathon runner raising money for a disease, and a clinical trial participant--the study volunteer came in last.
With the initial funding from Eli Lilly, CISCRP is set to roll out phase one of its "Everyday Heroes" campaign early this year, and the group hopes other companies will join the cause. "The idea here is to really focus on pre-education," said CISCRP chairman Kenneth Getz, who is also a senior research fellow at the Tufts Center for the Study of Drug Development. "We believe it's not negative media [that's creating misperceptions]--it's minimal to no coverage."
The lack of awareness has contributed to a "dramatic" decline in the response rate to recruitment materials, and companies are reporting that the responses are far below what they were seeing five years ago, he noted.
Jim Kremidas, director of global enrollment optimization at Eli Lilly, called recruitment the "biggest bottleneck" in the R&D process.
"We can influence it, but we can't really control it," he said. "Where the real wild card is is in the enrollment period. It's a very, very hot topic."
The first ad features a taxi driver stopped in traffic on a busy street. The light on top of his cab reads "HERO." "Medical heroes can be found in ordinary places," the copy reads. "Together we can make a difference through medical research." Viewers are then directed to the Web site smartparticipant.org and a CISCRP phone number. CISCRP has raised about 25 percent of the $1 million it plans to spend on the campaign in its first year. FDA has expressed interest in having its logo on the ad, according to Getz.
The ads, which were created pro bono by clinical trial recruitment firm Fast4wD Ogilvy, are slated to run in consumer publications like Time, Newsweek, and Prevention, on search-engine and health-info Web sites, and on billboards and buses in cities such as New York, Chicago, and Los Angeles. The scope and timing of the campaign are contingent on fundraising efforts.
CISCRP will measure the success of the campaign on follow-up research to see whether opinions of clinical trial participation have changed. A separate study from Thomson CenterWatch found that while 79 percent of study volunteers say that they're motivated to participate by a desire to advance science, their top concerns are convenience and risk.