Recruitment and Enrollment
Posted by: Jamie Zacher, PharmD
In clinical trials, sponsor companies are trying to prove that their therapy is effective and safe for patients to use. A critical component of the clinical trial is the patient. Recruitment and enrollment is a top priority for all clinical trials because without volunteers, there is no data to show that a therapy is safe and effective. A review of recently closed clinical trials in 2011 showed that 19% of trials were either terminated due to insufficient enrollment or completed with less than 85% of expected enrollment.  This means one in five studies is not recruiting enough volunteers. Why is this?
From our experience, there are several barriers to optimal and efficient recruitment and enrollment for clinical trials. Many people do not understand what a clinical trial is or how to become involved in one. When people are unaware that clinical trials exist, it is hard to recruit for the trial. For those potential patients who do know what a clinical trial is, many have misconceptions about how clinical trials work. This creates unnecessary obstacles for enrollment. Some obstacles include fear of being a ‘guinea pig’, protocol concerns, cost concerns, perceived risks versus benefits, mistrust in research personnel, etc. The list goes on and on.  Recruitment can be especially difficult in special populations, such as the elderly, neurodegenerative diseases (Huntington’s, Parkinson’s, etc.) and in minorities.
There are a number of things Sponsors and CROs can do to overcome recruitment and enrollment barriers. Communication is critical and the key to success. Clinical trial staff need to educate patients, ease concerns about clinical trials and breakdown any other barriers that exist. Sponsors can also use patient advocacy groups to educate and recruit patients. This can be accomplished through advertisements in the newspaper, online, radio and television. The public can then learn more about the clinical trials and studies for which they are appropriate.
Sponsors can also design the trial protocol to be as simple as possible to make it easier for volunteers to meet protocol requirements. Educating colleagues, such as family physicians, about clinical trials that are available, can also help direct volunteers to resources and clinical sites. People are more inclined to participate in a clinical trial when they are referred by a family physician whom they trust.
Reaching out to special populations and minorities is also a very important part of recruitment and enrollment in clinical trials. Education plays a big role in these groups as well, especially in minority populations where there may be cultural differences and language barriers to overcome. Providing educational material in other languages and study personnel who speak different languages can also be extremely helpful in recruiting appropriate populations. For the elderly, transportation arrangements may be critical to helping them make it to their appointments.
The bottom line is – it’s still about the person! It’s important to make volunteers feel like they are the top priority in the study. Educate them so they feel comfortable and confident in the clinical trial. The goal is to recruit and enroll patients and to keep them in the study from beginning to end to test drugs and therapies better!
1. Carlisle, B., et al. Unsuccessful trial accrual and human subject protections: an empirical analysis of recently closed trials. Feb 2015.
2. Williams, S. Clinical trials recruitment and enrollment: attitudes, barriers, and motivating factors. August 2004.
Case StudyA Biopharmaceutical Company Sponsoring a Phase II Clinical Trial in the U.S.
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