Clinical Translational Science Awards (CTSA;s) have created robust infrastructures to run clinical studies at major Health Care Centers. They have patients and personnel, but limited funding for targeted studies unless supported by a commercial interest. Many studies of nutriceuticals, or complementary agents have been done, but very seldom with adequate numbers to get a well-powered outcome. I suggest that care givers ...more »
Enhancing Study Site Capacity
Goal: Create the capacity of study sites and research organizations to increase enrollment for an ever-growing portfolio of Alzheimer’s disease and related dementias studies.
Ideas in this area might address:
- Infrastructure investments needed to enhance capacity of sites to accommodate growing number of studies and participants
- Systems to improve recruitment efficiency
- Collaboration – with communities, other institutions and study sites, organizations and agencies
- Workforce diversity, training, and capacity
- Changes in culture or valuation of clinical research in organizations
- Effective use of registries
- Role of funders, organizations, policymakers in implementing
Incentivise participation in a nationwide campaign research study (involving all forms of national, regional and local media) by offering the most researched and science based lifestyle programs to potentially thwart the disease. Provide participants with in-depth, diverse, whole body health knowledge as part of study participation agreement. Engage community involvement, i.e. churches, community organizations, health ...more »
Manage and coordinate relationships with research volunteers, study partners, and clinical providers by embedding client relationship management software (CRM) at local research centers.
Site recruitment proposals should include a community engagement outreach plan (separate from, but complementary to recruitment/retention plans) as part of the grant application process, which would list strategies to be implemented and an operationalized plan to do so (with an appropriate budget) that would span the life of the grant, with a focus on sustainability of partnerships for other future recruitment efforts. ...more »
Foster an environment that incentivizes and prioritizes recruitment, enrollment, and retention in high-quality clinical trials and studies. Communicate to academic leaders that clinical trials work is scientific work and should be rewarded, supported, and recognized accordingly.
Fiscally reward high-enrolling sites (e.g., cover start-up costs, set enrollment targets from the outset, and offer financial gain for reaching targets).
Link community-based supportive care agencies and organizations to research referral opportunities (to support patients, caregivers, and primary care practitioners), such as including clinical trials discussions and referrals in reimbursement for care consultation.
Create clear institutional or site-level guidelines and training focused on the differentiation of recruitment from coercion, and include Community Advisory Board (CAB) members and other community partners in the development of this program.
Offer community programs not targeted specifically to research recruitment (e.g., brain health/fitness, cardiovascular/diabetes risk, and memory screening). Ensure that recruitment staff connect with families and potential participants before discussing research. Ensure when feasible that a budget and plan exist to expand a site’s capacity to serve the community as a resource.
Respond promptly (within 1-2 business days) to inquiries or contacts from potential recruits. If necessary, the first response can be just an acknowledgement of the inquiry, but within no more than one week, the potential recruit should be screened and have an opportunity to ask questions.
Consider collaborating with existing registry programs or creating local registries to find potential volunteers. Incorporate trial-ready cohort programs, such as TRC-PAD and EPAD, into the screening model as a method of high-efficiency enrollment.
Develop nimble staffing models to respond to fluctuations in recruitment needs and to minimize staff burden and risk of burnout during periods of heavy enrollment.