Clinical trial teams embarking on large, multicenter studies can use the steps outlined in this framework to develop a centralized and standardized recruitment strategy. This approach can help to reduce site-level burden while also expediting recruitment. Clinical trial teams involved in single-site or smaller scale studies can use this framework to guide development of outreach and recruitment materials. To complement and facilitate your strategy, this chapter also presents a toolkit of materials and examples of methods employed by other Parkinson ' s research teams to enhance their recruitment efforts.
Understand Your Target Population through a Recruitment Committee
Forming a recruitment committee early in the planning phase of a clinical trial is fundamental to better understanding your target population and developing an effective strategy. This committee can take the lead on developing a set of centralized and standardized outreach materials to be distributed among your sites, helping to reduce burden and facilitate recruitment. It is important to include a diverse set of stakeholders on the committee, who will bring a variety of perspectives, cultural sensitivities and experiences with outreach to the discussion.
Objectives
The recruitment committee develops the recruitment strategy and communicates it to others. It creates messaging and standardized materials, talks to study leadership and to sites about the strategy and how it should be implemented, and fields questions or concerns as they arise. Additional objectives for the recruitment committee are to:
+ + Guide study leadership on goals of the target population( i. e., what are their desired health outcomes, motivations to participate, perceived benefits from participating)
+ + Provide insights regarding off-ramps( e. g., potential barriers to participation, frustrations with clinical research or study teams, challenges with current therapies)
+ + Offer feedback on messaging( e. g., cultural sensitivities, vernacular, reading level) and the most effective methods for conducting outreach to the target population( s)( e. g., where do they get their information, how do they prefer to get their information, are they online)
+ + Facilitate outreach among target audiences( e. g., do they have networks that they can engage to promote your study and how best to engage them)
+ + Monitor recruitment strategies and adapt as necessary
Potential Members
Designate a member of the study’ s steering committee to lead the formation of a recruitment committee. The recruitment committee should include stakeholders from a number of different groups, but should not be so large that it becomes difficult to make decisions quickly and efficiently. An ideal number of participants in the recruitment committee is between eight and 12. For example:
+ + Study principal investigators( 1-2) + + Study project manager( 1)
+ + Contract Research Organization project manager( 1)
+ + Clinical trial site representatives( e. g., site investigators or coordinators)( 2-3)
+ + Patients with Parkinson’ s disease and / or care partners( 2-3)
+ + Representatives of patient-facing or advocacy organizations( 1-2)
+ + Representatives of federal organizations or neurodegenerative disease associations( 1)
+ + Community clinician( e. g., movement disorder specialist, neurologist, primary care physician)( 1)
To ensure your recruitment committee embodies a variety of perspectives, you may want to consider that patients and other community representatives have participated in clinical trials( or have other relevant experience) and are frequently engaged with lay audiences, through support groups or other
18 Accelerating Clinical Trials: Best Practices for Recruitment and Retention