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.
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
Create practice-based research networks with clinicians and relevant specialists and provide value or incentives, such as compensation, professional recognition as a contributor to research, and exposure to the research community, to clinicians to ensure the networks are sustained.
Develop/utilize a centralized expert ‘Navigator’ team to assist sites to adapt and implement the Alzheimer's recruitment strategies; The Navigator ‘hub’ of experts could be supported through joint funds provided by NIA, Alzheimer’s Association, ACTC, and site budgets.
At the site, develop a mechanism to support person(s) to lead planning, networking, implementation, and evaluation of strategies and tactics, potentially a stand-alone add-on module (to a traditional R01) that would fund an Outreach Specialist, the %FTE to be determined by the proposed scope of work. Module would require annual status report and metrics of success for renewal of NIH funds, which would emphasize successful, ...more »
This could include: 1) Identifying the project’s target populations and develop a staffing and outreach strategy that is appropriately sensitive to this goal. 2) Developing employment descriptions that capture relevant experiences with the target communities and specialized skills (e.g. language facility, familiarity with the community). 3) Identifying opportunities to leverage staffing resources from other academic ...more »
Run multiple, complementary studies at a site so that screening efforts are not specific to one trial and can offer more than one research participation option for many volunteers, such as those at varying stages of disease.
Explore the feasibility of placing amyloid PET scanners in optimal locations and returning results to local sites so investigators can pre-identify suitable candidates. Such an approach might also be applied to screenings and studies which require lumbar punctures. Devote resources to identifying people at risk earlier in the disease process (e.g., genetic, biomarker, clinical, demographic).
Invest in creating a community advisory board as part of the site team to help guide recruitment.
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.
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 »
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.
Implement a plan to support institutional and community-wide coordination among research groups and clinical/social services, including ensuring that study sites are fully accessible to local communities.
Establish a community screening center or offer a financial incentive to sites that can pre-screen for studies beyond their own investigations. Additional required informed consents should apply to all disease stages and trial interventions; locate such sites near principal investigator sites.
Invest in facilities to accommodate greater enrollment (e.g., ensure adequate space; equipment; and services such as pharmacy, lab, radiology, information technology support).
Partner with healthcare systems or insurers for research referral.