Drug sponsors need a better understanding of the factors that motivate patients to participate in clinical trials in order to design protocols that can help meet recruitment targets, according to a new report by the consulting firm Cutting Edge Information.
While 72% of drug sponsors, contract research organizations (CROs) and patient recruitment vendors surveyed by Cutting Edge for its report, Clinical Trial Patient Recruitment: Accelerate Enrollment, Increase Retention and Reduce Costs, indicated that they conduct pre-trial research into the motivations for patients to enroll in their clinical trials, the report found much of that research is “surface deep.”
Questions that could influence patients’ decisions about enrolling in a trial might include whether they are embarrassed by their condition, whether a daily office visit might be too painful a reminder that they are living with the disease, if they feel altruistic in joining a study, or whether they want the opportunity to increase scientific understanding of a disease. “The more information trial designers have about the patient population, the more likely you are to design a study that meets all enrollment goals,” said Jason Richardson, president of Cutting Edge Information. “More nuanced democratic research saves dollars as coordinators put limited funds into the right recruiting channels.”
The report suggests that experienced
patient recruitment specialists are best prepared to address these types of motivational issues. A clinical trial team may want to include a requirement for additional office visits in the protocol, for example, while a
recruitment specialist could identify the point at which site-visit frequency will increase drop-out rates. “Knowing your patient volunteers and making a strong effort to think like them ultimately helps teams better meet the many challenges of study recruitment,” said Richardson.
The demand for clinical trial subjects has increased in recent years, according to the report, particularly as the amount of safety data needed for drug approvals has swelled. The survey shows that keeping patients in clinical trials also has become more difficult, with drop-out rates as high as 30 percent in some therapeutic areas. At the same time, the survey reports there has been limited growth in the number of clinical investigators.
Despite these challenges, the research found that 11 percent of companies surveyed said they have no specific budget for patient recruitment efforts. In addition, less than half of drug sponsors said they use patient retention strategies, such as appointment reminders or transportation assistance, although CROs used these strategies in 67 percent of cases.
The report, based on survey responses and interviews with more than 80 biopharmaceutical companies and CROs, concluded that taking the time to evaluate trial sites and spending money on additional strategies could accelerate patient recruitment, eliminate delays, help meet enrollment targets and, in the long run, reduce clinical trial costs.
In addition, the report found that forming strategic partnerships with CROs that have dedicated patient recruitment groups and databases with site-specific demographic information could benefit a drug sponsor’s patient recruitment efforts. Having a strategic partner, rather than a single-trial contract, would be more likely to bring positive results, since the prospect of repeat business would mean CROs would try to provide the best service possible, even making short-term sacrifices for the sponsor. CROs also could develop capabilities to meet a sponsor’s patient recruitment needs if it knew what studies were in the pipeline.