Clinical research organizations face a multitude of challenges in recruiting and enrolling patients for clinical trials. Studies show that general barriers to a patient’s enrollment include a fear of being a “guinea pig,” concerns about the complexity of research protocols, confusion about which services are covered by the patient’s health insurance, logistical concerns (e.g., work obligations, lack of child care), and the belief that investigators may be more concerned with the research process than the wellbeing of the patients involved in the study.¹ As clinical research simply would not be possible without a goodly number of interested patients, the importance of designing clinical trials that are patient-centric, patient-friendly, and accessible cannot be overstated.
A white paper from Industry Standard Research suggests that difficulty recruiting and enrolling patients is the foremost reason why clinical research organizations fall behind on their projected timelines and lose a great deal of money in the process.² (One study found that 19% of the registered clinical trials that were discontinued were owed their failure to an inability to meet recruitment goals.3) The authors of the white paper collected recommendations from a variety of biotechnology companies regarding their opinions on best industry practices in patient recruitment/enrollment for clinical trials. Noteworthy examples include making use of a diversified set of recruitment techniques, creating databases so as to be able to specifically contact only those patients who fit the relevant criteria, and offering enhanced support to the staff members working on-site.²
In another survey of clinical research professionals, the most recurrent proposal offered by the respondents was that sponsoring organizations should “engage in effective study planning,” one important component of which is selecting an appropriate site.³ Having a strategic plan from the inception of a clinical trial sets a company up to make the most efficient possible use of its time and money. This is of particular importance in the realm of patient recruitment and enrollment, as not meeting patient accrual targets in a timely manner has the potential to completely derail an otherwise promising clinical trial. Furthermore, organizing a comprehensive plan for the trial allows organizers to ensure that proper attention and resources can be devoted to ensuring that patients feel they are being properly cared for, which is the best way to guarantee that the trial will be a positive experience for patients.
¹Williams, S. (2004). “Clinical Trials Recruitment and Enrollment: Attitudes, Barriers, and Motivating Factors.” Retrieved from: http://cro.rbhs.rutgers.edu/documents/clinical_trials_recruitment_and_enrollment.pdf
²Industry Standard Research. (2014). “The Expanding Web of Clinical Trial Patient Recruitment.” ISR Whitepaper. Retrieved from: http://www.isrreports.com/wp-content/uploads/2014/04/ISR-The-Expanding-Web-of-Clinical-Trial-Patient-Recruitment-Whitepaper.pdf
³Mahon, E, et. al. (2015). “Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey.” Applied Clinical Trials. Retrieved from: http://www.appliedclinicaltrialsonline.com/barriers-clinical-trial-recruitment-and-possible-solutions-stakeholder-survey
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