Pharmaceutical, medical device and diagnostics companies “have only scratched the surface” in their efforts to understand patient psychology so that clinical trial protocols can be better geared to meeting recruitment targets, say consultants Cutting Edge Information.
While 72% of respondents polled by Cutting Edge for its new study, Clinical Trial Patient Recruitment: Accelerate Enrollment, Increase Retention and Reduce Costs, said they conducted pre-trial research into patient emotions and motivations, much of that research was superficial, the study found.
Emotional motivators for or against enrolment might include whether patients are embarrassed by their condition; whether daily office visits will be too painful a reminder that they are living with a disease; whether patients will feel altruistic in joining a trial; and whether they are exercised by the opportunity to enhance scientific understanding of a disease.
Respondents also cited geographically focused recruitment as a significant potential advantage. Identifying patient clusters helps with clinical site management and determining the best patient incentives, while allowing the clinical team to communicate directly with local advocacy groups, Cutting Edge points out.
“The more information trial designers have about the patient population, the more likely you are to design a study that meets all enrolment goals,” commented Jason Richardson, chairman of Cutting Edge Information. “More nuanced demographic research saves dollars as co-ordinators put limited funds into the right recruiting channels.”
The increased pressure from regulatory agencies for drug safety data has pushed demand for clinical trial subjects “exponentially higher”, the study notes. This is exacerbated by relatively flat growth in the number of available trial sites and investigators: in other words, the capacity to perform trials is not keeping pace with demand.
Retaining patients through rigorous morbidity and mortality trials can be even more challenging, with drop-out rates as high as 30% in some therapeutic areas, Cutting Edge adds.
Successful patient recruitment calls for “an investment of time and money that many drug companies rarely consider when setting a study budget”, the study says. Sponsors may skip important elements of the recruitment and study process, such as demographic research or patient retention strategies, to save money.
According to Cutting Edge, though, taking the time to evaluate trial sites and spending money on additional tools will accelerate patient recruitment, eliminate delays, help to meet enrolment targets and, in many cases, reduce costs in the long run.
The study includes five key findings and recommendations, as follows:
• Patient retention strategies are underused by the healthcare industries. These strategies were employed by only 50% of survey respondents, although contract research organisations (CROs) used them in 67% of cases. The most popular strategies are telephone call reminders, treatment follow-up by phone, transportation assistance and print/paper support materials. Some trial managers are starting to incorporate newer technologies, such as e-mail or text-message visit reminders.
• Evaluating potential sites and investigators improves patient recruitment. Nearly all survey respondents agreed that the most effective way to improve recruitment was by conducting a thorough evaluation of trial sites and investigators.
While 95% of respondents conducted these evaluations, though, in only 6% of cases did sponsor companies take the lead. CROs were responsible for this activity 47% of the time, followed by sponsor-hired vendors (37%). As the study observes, site evaluation requires more than just finding locations with the right patient population. It is also about capability, such as the research history and performance of the site.
• Companies should tap into patient motivators, such as altruism, improved/free treatment and convenient protocols, to speed up recruitment. The biggest motivator for patient participation in a clinical trial is altruism, the study found. Among more concrete motivators, though, the most effective is the prospect of improved treatment, followed by the convenience of site locations –not just proximity but factors such as office hours, on-site childcare or free parking – and the prospect of getting free medication, Cutting Edge reports.
• Sponsors need to set a patient recruitment budget. Companies often do not plan adequately for patient recruitment, even though they recognise it as a bottleneck in the clinical trial process, the study notes. Moreover, 11% of the companies taking part in the study revealed that they did not budget any funds at all for patient recruitment efforts.
“The approach of ‘if we conduct it, the patients will come’ is inconsistent with the goals of clinical research, which should incorporate rigorous processes to identify and target patient populations,” Cutting Edge comments. Moreover, for a blockbuster drug a six-month delay due to poor patient recruitment execution could cost “hundreds of millions to billions of dollars” in lost sales.
• A strategic partnership with a CRO familiar with patient recruitment can significantly boost recruitment speeds, particularly for small sponsors or those lacking experience in a particular type of trial. External groups “are most likely to provide top-quality results if the relationship is structured as a strategic one, rather than as a single-trial contract”, Cutting Edge says. “Naturally, vendors are more likely to go out of their way to meet sponsor needs if they see the prospect of more business in the future.”
Other benefits include reduction of trial-specific negotiation times once a master agreement is in place; and a better understanding of each other’s needs and limitations. CROs can develop their own capabilities to meet a sponsor’s needs if they are familiar with trials in the pipeline, the study points out.