Recruiting is one of the biggest challenges in clinical research, and as competition for patients heats up, sponsors face increasing challenges in meeting these goals. Tufts Center for the Study of Drug Development estimates that more than $2 billion is spent annually on recruiting patients for clinical trials, and that 11% of sites never enroll a single patient and 37% under-enroll.
Reducing the enrollment period on a clinical trial by even a few days, can translate to significant savings, and sponsors are eager to find innovative strategies that will help them improve their recruiting outcomes. In recent years we’ve seen the development of many innovative tools to improve recruiting strategies, including the use of clinical trial educators (CTE) to help investigators engage and retain patients throughout the trial lifecycle. CTEs can help drive recruitment, improve retention and ultimately shorten study timelines, saving money now and post-marketing.
One of the benefits of CTEs is that they are professional nurses vetted for their specific knowledge of the disease, as well as for their technical, therapeutic, analytical, and training skills. Their core role focuses on education and collaboration with site staff to build referral networks and identify any obstacles that might prevent patients from joining and staying with a trial.
As part of the project, they may provide Lunch and Learns, database mining, visits with referring physicians, site staff education sessions on protocol and procedures, or simply be available to the site team when questions arise. They also work as close liaisons between sites and referring networks keeping lines of communications open between CRAs, sponsor leads, and site staff.
Along with supporting trials from the outset, CTEs can be brought in to help problem-solve when a trial falls behind on recruiting goals, or faces unexpected obstacles. On one recent multi-center trial for diabetic nephropathy, for example the U.S. sites were facing a lackluster rate of enrollment in part due to competing local trials targeting the same patient population, which put the trial at risk of meetings its recruiting goals. A CTE team was brought in to help energize the enrollment process and meet recruiting goals. The CTE team enhanced the patient recruitment strategy with dedicated support toward site engagement, which resulted in more consistent prescreening, screening and randomization processes. These benefits translated to conversion rates of 90% for prescreening, 80% for screening and 60% for randomization. Thanks to their support, all timeline milestones for the trial were met, saving the sponsor substantial time and money.
Most clinical trial experts agree that a main contributor to financial loss in a study is due to delays in enrollment, followed by retention of committed participants. As more pharmaceutical companies scrutinize ways to complete trials in a highly competitive market, we believe CTEs will become a vital part of the clinical research process. They can improve performance, prevent problems, and reduce the rate of attrition, especially on long term trials where patients may lose patience with the process.
This is just one of the many innovative ways we are working to deliver a more efficient, and value-driven clinical trial experience for our partners and patients.