Four Essentials for Clinical Trial Enrollment
Clinical trial enrollment continues to be one of the most vexing challenges for research institutions and sponsors. Despite one quarter of sponsors’ clinical trial budgets being allocated to enrolling participants, half of research sites enroll only one or no patients in studies. Recruiting a diverse patient population is an even bigger challenge, with ethnic minorities, women and the elderly often underrepresented in clinical research.
Typically a contract between an investigator and the sponsor will outline the number of participants to be enrolled. The inability to enroll the required number of patients can have serious implications for the study’s success. Eighty percent of clinical trials fail to finish on time and 85 percent fail to retain enrollees, leading to canceled trials. Not meeting enrollment targets can dampen the relationship between the investigator and the sponsor and perhaps diminish future opportunities for the research site.
The vast majority of patients are willing to enroll, if only they know it’s an option. Eight-five percent of patients were either unaware or unsure that they could enroll in a trial, according to a Harris Interactive Survey of cancer patients. But 75 percent of these patients said they would have been willing to enroll had they known it was possible.
Sponsors are turning to artificial intelligence, machine learning and other technologies to provide detailed predictive analytics in an effort to improve recruitment. These technologies can comb through thousands of electronic medical records and other demographic data, and cross-reference criteria from hundreds of available trials. Microsoft just announced a chatbot designed to match patients to trials.
Sponsors must continue to work closely with research sites to coordinate the most effective methods of finding and enrolling patients, however. Even with new technologies, research coordinators and investigators play the most important roles in the successful recruitment and retention of clinical trial participants. By nurturing relationships in patient communities, a human-centered approach can yield demonstrably improved results.
Budget for recruitment. Recruitment and enrollment takes the time of the research coordinator and other staff—time that needs to be accounted for in the study budget if the research institution is to avoid working at a loss. When budgeting, consider the entire process of patient recruitment, not just the advertising budget, to ensure an accurate assessment of resources used.
Collaborate with colleagues. Investigators and research coordinators should network and collaborate with their colleagues in other specialties, and leverage these relationships to encourage patient referrals to clinical trials. Many clinical trials cross over different specialties. For example, a study may encompass both cardiology and endocrinology for heart disease and diabetes. Creating a network, even an informal one, to share ideas and proactively discuss clinical trials with their patients will raise awareness.
Understand the compliance issues. Compliance issues impact patient enrollment in a variety of ways. For example, if you will be reviewing medical records to identify potential research participants, you may need a partial HIPAA waiver for recruitment purposes from the IRB to share information.
Compliance also impacts any traditional advertising and marketing. Sponsors may sometimes run larger national awareness campaigns for certain clinical trials, but for others it’s often up to the investigators to reach out within their own community through traditional advertising methods. This can include newspapers, radio and local cable television. It can be as simple as distributing flyers in places where potential participants may see them. Whatever media you use, the IRB needs to review the material before it is released. Physician-to-physician letters may not require IRB review so check your IRB’s policies in advance. Consider advertising a step in your recruitment plan.
Monitor progress. In the course of running a busy clinical practice, it may be easy to let your recruitment efforts slip. At the beginning of the trial, schedule regular “touch base” meetings with your team to learn what you are doing to recruit participants and how successful those efforts are. If an activity is not yielding results, you can replace it with something else and not waste unnecessary time and effort.
Technologies are moving rapidly in artificial intelligence and machine learning. Staying abreast of these developments and trends can keep you ahead of the curve and aware of opportunities for your practice. However, personal relationships and human contacts are still an essential part of the patient recruitment toolkit.
 Clinical Leaders