Statistics of the Current Recruitment Climate

Current issues

The big three issues curbing subject recruitment enrollment numbers are lack of treatment naïve patients, the increasing percentage of serial enrollers, and protocol issues. All speak to the problem of meeting inclusion/exclusion criteria, as well as retaining subjects once the trial begins, based on the protocol design.

Inclusion/exclusion criteria and subject retention go hand-in-hand with the current protocol design environment. Laura Gibson, associate director, project management for i3 Research, said, "There has been a trend in the past three to five years, that FDA will say, 'We like what your data says, but we want to see more.'" It is a trend described as conducting 'specialty' studies, and they are definitely more complex and require much more investment for study subjects, investigative sites, service providers, CROs, and sponsors.

In addition to being more complex, sometimes what the FDA requires is unachievable for subject retention, let alone in finding that subject.

For example, one panel member described that for safety reasons FDA required a study to be conducted in adults who were newly diagnosed with a condition typically diagnosed in childhood—an obvious patient recruitment challenge.

"It is important to test the feasibility of a protocol by actively assessing whether patients, with the required eligibility criteria, actually exist," explained Mark Zumbach, director, patient recruitment and retention, Global Access to Patients, Quintiles. "Moreover, we need to consider whether these patients would be prepared to participate in the trial. Too often we find out far too late that the protocol is designed for patients that don't exist or that the requirements of participation are not acceptable to patients."

These CRO experts concurred that they would benefit from being brought into the protocol design stage to help determine the feasibility of finding subjects for the study. In addition, the RFP turnaround time is too short. Too short for even the most autonomous of in-house subject recruitment specific departments, such as Zumbach's at Quintiles, to determine the best strategy or even if the services of an Acurian of the world would best benefit the study in question.

However, this is just not the way the current sponsor/CRO/service provider relationship works. Right now, the relationship is still dependent on the sponsor coming to the CRO with the protocol and focusing on first-patient-in as the primary milestone; the CRO focusing on getting the contract and not being held to a promised 50% screen-fail rate; and then the subject recruitment specialists—either in-house or provider—being brought in when the trial hits rescue mode.

Entrane Harvey, manager Phase IV development at PharmaNet, noted that this current landscape will definitely change based on current economic conditions, as well as changing business models among these shareholders. "The CROs, pharma, and fee-for-services providers will be involved in more risk-taking and risk-sharing. And pricing algorithms need to change," he said.

Current solutions

Applied Clinical Trials recently featured in its March 2009 issue a special insert titled Trends in Subject Recruitment 2009. The articles presented strategies and software solutions offered by service providers. Many of these solutions focused on metrics, predictive enrollment modeling, and operational simulations as a way to thwart last-minute (and costly) rescue initiatives in trials by keeping up to date on current enrollment and sticking to predictive enrollment schedules.

These solutions are predicated on huge amounts of proprietary data collected by the providers that allow them to predict site enrollment based on previous enrollment, or project subject availability of certain disease states based on claims data in a geographic area, or even to approximate the level of study participation based on in-depth online feasibility questionnaires.

Another current solution? Social networking via Internet. Beth Craig, RN, BSN, executive director, patient recruitment at PRA, said PRA is incorporating social networking into its overall strategic global initiatives. "We evaluate and selectively recommend to some clients to consider social networking as a method of informing potential participants about clinical studies recruiting in their geographic area. We take this very slowly, evaluate each country regulatory and communication guidelines. It is interesting and certainly based upon the disease and age group, an option for recruitment."