Recruiting patients into a clinical trial takes careful planning and flawless execution from multiple sources. Although the site is often responsible for contributing the majority of patients needed to meet enrollment targets, there is not one single person or role that is ultimately responsible for patient recruitment. Principal investigators, study coordinators, clinical research associates (CRAs), sponsors, CROs, feasibility analysts, patient recruitment specialists and consultants all play a role.
Feasibility is the precursor to site selection. Before sites are even selected for a clinical research study, the feasibility analyst plays an essential role in patient recruitment. The feasibility analyst looks at crucial factors that help determine where the trial will be feasible. Location recruitment factors include examining whether the disease is relevant to the study population, gauging whether there may be ethical concerns, vetting out the study design and looking at comparable trials. Assessing these and other factors helps predict which sites would be appropriate for a particular clinical research study. The feasibility analyst then looks at prevalence rates of the disease or condition to determine if a site can realistically support the study. Once a site is selected for a trial, it is expected to recruit a specific number of patients within a predetermined amount of time.
Sites play a large role in patient recruitment of a clinical trial. Historically, approximately 80% of study volunteers were “pulled” from within the site’s own environment and the other 20% were “pushed” to the site from various outreach methods. According to the ISR whitepaper "Expanding the Web of Clinical Trial Patient Recruitment," 28% of patients in a clinical trial are not active patients at the site. It is expected to increase in the next few years to as much as 35%, which will place more of the patient recruitment responsibility on patient recruitment professionals.
The principal investigator and the study coordinator are crucial to patient recruitment. After a site is selected, one of the first steps it will take is to look within the site database to identify potential patients that meet key eligibility criteria. Finding eligible patients is only the initial step because once identified, the potential patient must then be educated about the opportunity. If the patient is interested, he or she must then proceed through the informed consent process.
Sponsors are also responsible for patient recruitment and need to have an outreach plan for their clinical trials. Rarely do sites enroll 100% from within their own databases, and outreach activities, whether traditional or online, are required to supplement them. For the sites to leverage their existing patient pools, they need to have the proper tools to aid them in communicating study opportunity to potential patients. Tools potentially provided by the sponsor may include informed consent aids like videos or flip charts, patient or caregiver brochures and patient and referring physician letters designed to spread awareness.
A CRA’s main function is to ensure the clinical trial is conducted according to Good Clinical Practices while following company standard operating procedures. Even though the main function of a CRA is to verify that the trial is being conducted appropriately, they still play in a role in patient recruitment. Because the CRA makes in-person visits to the site, they are in a crucial position to determine if there are specific barriers to recruitment. The CRA also has the ability to escalate recruitment issues and help ensure site-specific enrollment barriers are overcome.
Finally, there is the patient recruitment specialist. This role can exist at a site, sponsor, CRO or vendor. The recruitment specialist manages patient recruitment activities. Each trial has different planning and execution criteria and needs, but unlike the other roles involved in patient recruitment, the patient recruitment specialist has a single, focused goal to ensure successful recruitment in the trial. This expert should be familiar with best practices, methods and optimization to get the most from recruitment spend.
With all of these roles contributing to recruitment, communication is key. It takes all parties working together with a common goal to recruit effectively.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. She currently provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment LLC. Email comments and suggestions to firstname.lastname@example.org.
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