Clinical Trial Educators: Catalysts for improved patient recruitment
By: Stewart Rosen, M.D. | January 25, 2017
How CTEs can help bolster patient recruitment and retention.
Life sciences companies sometimes lose sight of patients while they focus their energy and resources on research for breakthrough drugs. Slow-moving clinical trials prevent timely access to life-altering medications, which can hinder patients’ chances for longer, better lives and maybe even survival. Sluggish trials make it difficult for companies to survive as well — they can lose as much as $8 million each day a drug is delayed from reaching the market.
A main reason for the slow pace of trials is that researchers struggle to attract and retain patients needed to complete studies on time and within budget. According to a 2016 Wall Street Journal article, about 1.7 million patients participate in 80,000 drug company-sponsored trials worldwide each year, and companies spend an average of $300,000 to recruit each participant for a Phase III clinical trial. However, nearly half of trial sites (48%) miss their enrollment targets, according to a 2016 study from the Tufts Center for the Study of Drug Development (CSDD) in its 2016 R&D Management Report called, “Patient Recruitment and Retention 2.0.” Although 89% of trials ultimately meet patient recruitment goals, the Tufts report continues, drug companies must nearly double their original timelines to achieve that result.
A major stumbling block in recruiting patients for trials is the fact that, typically, physicians and other healthcare providers (HCPs) are not effective at recruiting. A common belief is that HCPs rarely refer patients to clinical trial sites because they are afraid of losing them. However, the Tufts study found that many HCPs do not make patient referrals because they are unfamiliar with principal investigators (PIs) and trial sites in their community or they do not know the trial protocol well enough.
Patients need more knowledge about trials as well. The SubjectWell Survey of Clinical Trial Awareness and Attitudes found that 50% of patients surveyed had never heard of relevant clinical trials and only 31% felt confident or very confident that they know how to obtain information about trials.
At today's SCOPE (Summit for Clinical Ops Executives) conference, I’ll highlight one approach to improving patient recruitment that has proven successful — utilizing nurses and other clinicians in the role of clinical trial educator (CTE). CTEs visit local healthcare providers (HCPs) on behalf of the clinical trial site, share information about a study and patients who could benefit, and create a simple process that makes it easier for HCPs to refer their clients to a trial. CTEs help HCPs keep trials top of mind.
CTEs must have expertise in a given therapeutic area, but to completely fulfill their role, they must also be proficient in clinical research, have customer service acumen, presentation and relationship-building skills. CTEs must be perceived as a peer with clinical trial personnel so they can confidently interact with the trial site staff and other non-site HCPs to educate them about the opportunity for patient referrals.
A CTE identifies a clinical trial site’s needs, focusing on barriers for patient recruitment, then addresses the needs in a variety of ways, including reinforcement education of staff on trial protocol requirements and educating referral networks on patient enrollment opportunities.
CTEs also play another role: strategic partner for site visits by monitors, or clinical research associates (CRAs). The CTE assists site staff in resolving educational deficiencies that compromise the efficiency and accuracy of trials. Unlike CRAs, the primary focus of CTEs is recruitment. Their insights and regular contact with the sites mean that they are able to build strong relationships with site staff, gain an understanding of recruitment barriers, work with the research teams and associated staff members to overcome these hurdles.
The life sciences industry spends a lot of time and costly resources developing breakthrough medicines, but rarely teaches clinical trial staff how to effectively present the concepts of the trial to patients so they understand its process and purpose. CTEs coach and counsel staff on the best ways to convey this information to patients.
QuintilesIMS CTEs have achieved dramatic results in shortening clinical trial timelines. At the SCOPE conference, I’ll discuss one case in which a large pharmaceutical company used Quintiles’ CTE program to accelerate patient enrollment for a Phase III clinical trial of an investigative cardiovascular therapy across sites in the U.S. and Canada. Our CTEs visited 296 potential study sites and identified 38 sites that were activated. They made more than 7,100 visits to healthcare professionals, visiting 96% of targeted sites. Following the introduction of CTEs, monthly enrollment rates for the study increased by as much as 85% and overall subject enrollment increased by an average of 34%. The trial completed enrollment six months ahead of the targeted date.
As the number of clinical trials continues to grow and life sciences companies strive to keep pace by conducting trials faster and more efficiently, the role of the CTE will expand. In the future, CTEs will have role-specific technology, so as data on HCPs increases, CTEs will be better able to identify those to contact for patient referrals. A CTE’s work as an ambassador for a clinical trial increases the chances that when an eligible patient presents, an HCP has the trial top of mind and will recruit the patient, thereby helping the trial achieve its enrollment goals.