By Stewart H. Rosen, M.D.

A successful clinical drug trial needs capable investigators, trial coordinators, support staff, medical personnel, and an important role that is difficult to fill—patients to participate in the trial. Challenges associated with the identification of subjects to participate in a study can cause serious bottlenecks and delay study completion. The long-term consequences of such delays are significant. Patient access to important therapies will be deferred and sponsors may lose millions of dollars as a result of postponed commercialization. That’s why life sciences companies spend an average of $300,000 to recruit each participant for a Phase III clinical trial. [1] Despite this investment, 80% of trials fail to meet their initial patient enrollment quotas, slowing development and causing financial losses as high as $8 million a day. [2]

This challenge is compounded when it comes to specialty medicines where the patient pool is small and often geographically dispersed. In cancer clinical trials, for example, it costs approximately $50,000 to initiate a study site, yet 20% to 30% of study sites never enroll a single patient. [3] In addition, attrition rates for Phase III clinical trials, which have reached 30% to 40%, are often attributed to issues such as convenience and efficacy rather than safety.

Surprisingly, the biggest stumbling block that prevents clinical trials from reaching recruitment goals is a lack of awareness. A Harris Interactive Survey found that 85% of patients surveyed were either unaware or unsure that participation in a clinical trial was an option at the time of their diagnosis. The same study showed that 75% of those patients said they would have been willing to enroll in a study had they known it was possible. [4] Further, the SubjectWell Survey of Clinical Trial Awareness and Attitudes showed that 50% of patients surveyed never even heard of relevant clinical trials and only 31% felt confident that they knew how to obtain information about trials. [5]

To overcome these obstacles as the traditional drug-discovery process continues to grow in cost and complexity, life sciences companies are increasingly looking for ways to achieve sustainable R&D models that lower costs and maximize return on their investments, such as more efficient and effective patient recruitment models. Enter: clinical trial educators (CTEs).

CTEs play a relatively new role in the pharmaceutical industry. They are highly qualified nurses, doctors or other healthcare professionals steeped in the specific therapeutic area of a clinical trial that support many different aspects of the trial—from training investigators to patient recruitment to consulting on future commercialization needs.

More and more, CTEs serve as catalysts to propel patient recruitment forward. They inform site staff on study protocol, support community outreach, share best practices, propose creative solutions to recruitment barriers, and help staff evaluate patient recruitment metrics. They make frequent follow-ups, contacting HCPs on a monthly basis in person as well as weekly by telephone, e-mail or webinars. Working on behalf of the sponsor and collaborating with the study site, CTEs engage with institutional departments and local HCPs about a study, the types of patients who would benefit from participating, and the process for referring patients to the site.

Although CTEs play a vital educational role, much of the responsibility for educating patients about clinical trials rests with healthcare providers (HCPs). Research shows that 77% of patients who participate in a trial learned about it from their HCP and 32% reported that their HCP took the time to explain the trial clearly. [6]

In spite of this, there’s a widespread belief that HCPs rarely refer patients to clinical trials because they fear losing them. Research by the Tufts Center for the Study of Drug Development (CSDD), however, 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—not because they are concerned with losing a patient. [7]

This is where CTEs enter the picture. Including CTEs in the patient recruitment process leads to an average patient enrollment increase of 30% or more. [8] By defining an efficient process for referring patients to trials, and driving both awareness and understanding of trials, CTEs help HCPs spread the word (and even serve as trial activists). When a match between a study and a patient arises, CTEs also work to prepare HCPs so they can best inform patients of the opportunity.

A good illustration of this is the privately held biotechnology company Intarcia Therapeutics, which leveraged CTEs throughout clinical trials for ITCA 650—Intarcia’s investigational drug for the treatment of Type 2 diabetes. Specifically, CTEs identified and networked with high-volume primary care clinics. “They would plan lunch-and-learn events about the clinical trials at physicians’ offices in a given geographic reach, which proved an incredibly effective source of local recruitment,” said Jay Smith, Intarcia’s Chief Experience Officer.

Intarcia also leveraged CTEs in a wide variety of ways that extend well beyond patient recruitment. “We developed a physicians’ training program that was administered by a global CTE team of 50 specialists across 34 countries and the team quickly mitigated unexpected regional challenges,” added Smith, “there are so many ways to leverage the value of CTEs, most importantly, to enhance the overall customer experience—both the physician’s and the patient’s—with a new product.”

Successful CTEs have a broad array of specific qualifications. First, they have clinical expertise in the therapeutic area of the trial so they can provide accurate details about the study to patients. Second, they are on a peer level with principal investigators, trial coordinators and clinical personnel so they can interact effectively with the trial site. Lastly, CTEs have the people skills required to provide good communication, customer service and training to shepherd the vast assortment of people and projects through the clinical study process in a timely manner. Successful CTEs have a strong customer-service mentality and are comfortable working in a culture of accountability—they are dedicated to the success of the protocol.

Research published in Clinical Trials demonstrates the effectiveness of CTEs. In the study, qualified CTEs made 2,184 visits to investigator sites in 18 European countries to train investigators and site personnel in patient recruitment for an acute coronary syndrome trial. The study came to this conclusion:

“We found a significant positive association between CTE site visits and the assessed recruitment-related study milestones in the trial, and enrollment finished ahead of plan. We propose that a CTE program could efficiently accelerate enrollment in other clinical trials and therapeutic areas and could contribute to shortening patient access time to novel and potential lifesaving treatments in cardiovascular medicine and beyond.” [9]

QuintilesIMS CTEs have achieved dramatic results in shortening clinical trial timelines. In fact, one US-based pharmaceutical company utilized the company’s CTE program to accelerate patient enrollment for a Phase III clinical trial of an investigative cardiovascular therapy across sites in the US and Canada. The CTEs visited 296 potential study sites and identified 38 sites that were activated. They made more than 7,100 visits to HCPs, 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. [8]

According to life sciences companies that have leveraged the CTE model in the past, it has contributed to increased awareness of the clinical trial at investigator sites. The CTEs’ regular presence at sites and their support in screening activities and on-site network identification has proven key to increasing the overall enrollment rate at these sites.

Despite the proven success of CTEs, some life sciences companies hesitate to add another expensive resource to a clinical trial program. Study teams are allocated a finite budget, and the high cost of a dedicated CTE can seem unaffordable. But when a company takes a high-level, long-term view of the benefits that a CTE can offer—including a trial concluding sooner, which makes a potentially life-changing medication available to patients more quickly, and the company realizing longer term exclusivity from the new therapy—the investment in the CTE model is a prudent one with substantial long-term value.

“Clinical trial educators bridged the important collaboration between sponsor and the sites in our critically important Acute Coronary Syndrome trial,” said one clinical trial management specialist. “Increased enrollment is only a part of their valuable contribution. Their insight, information sharing, and action plans have improved the operations of the trial in a way that cannot be adequately measured.”

As the number of clinical trials continues to grow and life sciences companies strive to keep pace by conducting faster, more efficient trials, 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. It’s never too early to engage a CTE because from the beginning to the end of a trial, the CTE serves as the common thread for the product development process. They are true experts on a life sciences company’s molecule delivery system. A CTE’s work as an ambassador for a clinical trial increases the chances that when an eligible patient presents, HCPs have the trial top of mind and will discuss participation with the patient, thereby helping the trial achieve its enrollment goals.

“Clinical Trial Educator Program—A Novel Approach to Accelerate Enrollment in a Phase III International Acute Coronary Syndrome Trial,” Clinical Trials, 2012. For more: 

http://www.ncbi.nlm.nih.gov/pubmed/22426648

eHealthInsight Series: Online Patient Recruitment Strategies. Datamonitor, May 2008

“A Patient Focused Solution for Enrolling Clinical Trials in Rare and Selective Cancer Indications: A Landscape of Haystacks and Needles.” Drug Inf J. 2012 Jul;46(4):472-478. For more: 

http://www.ncbi.nlm.nih.gov/pubmed/23990689

“The Need for Awareness of Clinical Research,” National Institutes of Health, 2016. For more: 

https://www.nih.gov/health-information/nih-clinical-research-trials-you/need-awareness-clinical-research

“The SubjectWell Survey of Clinical Trial Awareness and Attitudes,” SubjectWell, 2016. For more: 

http://www.prnewswire.com/news-releases/subjectwell-survey-reveals-significant-need-for-increased-consumer-education-on-clinical-trials-300229292.html

Comis R, Miller J, Colaizzi D, Kimmel L. “Physician-related factors involved in patient decisions to enroll onto cancer clinical trials.” J Oncol Pract. 2009 Mar;5(2):50-6.] For more: 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2790653/

“R&D Management Report: Patient Recruitment and Retention 2.0, 2016,” Tufts Center for the Study of Drug Development, 2016. For more: 

http://csdd.tufts.edu/reports/description/rd_single_issues

“Deploying Clinical Trial Educators to Increase Clinical Trial Recruitment,” Quintiles, 2011. For more: 

http://www.quintiles.com/~/media/library/experts/deploying-clinical-trial-educators-to-increase-clinical-trial-recruitment.pdf

As vice president of medical affairs, Stewart Rosen, M.D. develops medical educational models to aid patient health management through the management, training and deployment of medical science liaisons (MSLs), clinical nurse educators (CNEs), and clinical trial educators (CTEs). These teams help prescribers and practice sites to facilitate diagnoses, improve treatment regimens, support clinical research implementation, enhance patient adherence and improve outcomes. Dr. Rosen earned his medical degree from the Universidad Autonoma de Guadalajara, Mexico and completed his clerkship at Jamaica Hospital in Queens, New York.

As senior director and head of field-based medical operations, Nicola Smith has responsibility for developing and implementing solutions for customers requiring field medical deployment in Europe and emerging markets. She has responsibility for oversight of complex multi-country projects for both biotech and large pharma customers—often working with customers to facilitate medical activities leading to product launch. After graduating from the University of St. Andrews, Nicola worked at a WHO-sponsored research unit at St. Vincent’s Hospital Sydney before joining the pharmaceutical industry.

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Addressing patient recruitment and retention issues is a natural role for CTEs