Written for Stewart H. Rosen, MD, Vice President, Medical Affairs, Quintiles
Life sciences companies sometimes lose sight of patients while they focus on research for breakthrough drugs. Slow-moving clinical trials prevent timely access to life-saving medications, which can hinder patients’ chances for longer, better lives and maybe even survival.
Sluggish trials make it difficult for companies to prosper as well—they can lose as much as $8 million each day a drug is delayed from reaching the market.
About 1.7 million patients participate in 80,000 drug company-sponsored trials worldwide each year, and though companies spend an average of $300,000 to recruit each participant for a phase 3 clinical trial, nearly half of trial sites (48%) are unable to enroll enough patients.
A major stumbling block in recruiting patients for trials is the fact that, typically, physicians and other healthcare providers (HCPs) aren’t effective at recruiting. A common belief is that HCPs rarely refer patients to clinical trial sites because they’re afraid of losing them.
New research by the Tufts Center for the Study of Drug Development (CSDD), however, found that many HCPs don’t make patient referrals because they’re unfamiliar with the principal investigators and trial sites in their community or they don’t 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 that they know how to find information about them.
One approach to improving patient recruitment has been successful—utilizing nurses and other HCPs in the role of Clinical Trial Educator (CTE). CTEs visit local HCPs on behalf of the clinical trial, share information about the study, 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 specific therapeutic area, but to completely perform their role, they must also have customer service, presentation and relationship-building skills. CTEs must be peers with clinical trial personnel so they can interact effectively with them at the trial site.
Excellent Customer Service
A CTE identifies a trial site’s needs, focusing on barriers for patient recruitment, then addresses the needs in a variety of ways, including reeducating staff on the trial protocol and educating referral networks about patient enrollment opportunities.
Successful CTEs have a customer-service mentality and a culture of accountability—they’re dedicated to the scientific protocol and peer-to-peer relationship building. They make frequent follow-ups, contacting HCPs on a monthly basis in-person as well as weekly by telephone, e-mail or webinars.
Research published in Clinical Trials: Journal of the Society for Clinical Trials evaluated the effectiveness of CTEs. In the study, qualified CTEs made 2,184 visits to investigator sites in 18 European countries where they trained investigators and site personnel in patient recruitment for a 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.”
Quintiles CTEs have achieved dramatic results in shortening clinical trial timelines. For example, a large, U.S.-based 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 made more than 7,100 visits to healthcare professionals. After 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 try to keep pace by conducting them faster and more efficiently, the role of the CTE will expand. 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, thus helping the trial achieve its enrollment goals.