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Applied Clinical Trials
Thought leaders in the subject recruitment field come together to discuss current issues and potential solutions.
To discuss current issues in subject recruitment, solutions and options in these challenging times, a roundtable of recruitment and clinical research professionals was convened by Acurian, a patient recruitment solutions provider.
Statistics of the Current Recruitment Climate
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.
Lack of naïve patients and serial enrollers are issues related to enrollment, but they weren't central on the roundtable's agenda.
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.
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."
The professionals gathered at this roundtable all believed that ultimately, education is the key to converting patients to subjects.
The Center for Information & Study on Clinical Research Participation (CISCRP), is a nonprofit organization that offers national consumer-based awareness and education, patient education and outreach, and professional education and outreach, as well as policy and media programs, all in an effort toward public education.
What these professionals like about CISCRP is that education garners results. For example, when CISCRP partners its programs with a client's own recruitment campaign, enrollment results are significant. An article that appeared in this publication last year, http://appliedclinicaltrialsonline.findpharma.com/EverydayHeroesCampaignCapturesPublic, described the success rates Eli Lilly had when using CISCRP's "Everyday Heroes" campaign concurrently with its subject recruitment advertisements. Specifically, its clinical trial enrollment figures went up 35% per month.
According to Lani Hashimoto, executive director, specialized site services at i3 Research, the cost to use the CISCRP program and to fund its educational initiatives is a "drop in the bucket" compared to the change and difference it could make within and outside of the industry.
There is also the stigma attached to the pharmaceutical industry itself, which remains a barrier to public trust in the industry that also remains largely unaddressed except by programs such as CISCRP.
"What's good for one of us is good for all of us," said Zumbach, in regard to funding CISCRP, which was the general consensus of the group.
However, the nature of CROs is still competitive. Couple that with dated view of some sponsors regarding subject recruitment activities, and certain funding projects can die on the vine pretty quickly.
For example, if an investigative site is conducting multiple clinical trials in diabetes, and performing sites most likely will be conducting trials for multiple sponsors, then sponsor A may not want to provide advertising dollars. Why? Because it may, ultimately, benefit someone else's study.
With print newspapers folding on a regular basis; the Tivo and iPod effect of eliminating commercials on television or in the car; and a multitude of Internet sites that offer online connection to a clinical study, what is the best way to reach the patient?
For Julie Szabo, MS, director, clinical research at PharmaNet, more creative solutions are working. "We were able to get a local reporter at a newspaper to interview the PI about the study. We asked the IRB first and received agreement to move forward with this strategy. In response to the newspaper article, the site received a number of calls about the study, and several patients turned out to be eligible, so this helped." She noted: "We've been trying to raise the game and be creative to ensure our success with difficult patient populations and aggressive recruitment timelines."
Szabo also believes that extra efforts to educate nonstudy-affiliated site personnel on the trial can sometimes create a fruitful patient referral pathway.
Other site level initiatives also are becoming more important as the CROs realize how greatly overworked and overwhelmed are the study coordinators and investigative site staff.
For Melissa McCown, associate director, Global Access to Patients at Quintiles, the value of building site relationships and recognizing work well done at the site level should not be underestimated. She related a story where she called and personally thanked a study coordinator for being the first site to enroll a patient in the trial. "The coordinator called me back and thanked me for thanking her," she said.
Craig said, "We've been focusing on building the study coordinators morale. We've had educational lunches, sent them cards, which makes them feel appreciated," she said.
Subject recruitment professionals, contrary to popular belief, do not have the crystal ball to predict human behavior. McCown stressed: "It's a patient decision."
Acurian brought together these thought leaders to start a dialogue of sharing. The participants agreed that these meetings are helpful and should continue.—Lisa Henderson