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Advisory Council January 2021 Meeting Presentation: NIAs Clinical Research Update

Monday, January 25, 2021

Printer Friendly Version in PDF Format (17 PDF pages)


An Update on NIA's Clinical Research Recruitment & Retention Initiatives

Holly A. Massett, PhD
Senior Advisor, Clinical Research Recruitment & Engagement
Division of Extramural Activities, NIA

Minority recruitment initiatives

  1. Clinical Research Operations and Management System (CROMS)
  2. Increase Awareness of AD/ADRD Clinical Research
    1. Materials Development
    2. Online tool: Outreach Pro
  3. Community Practitioner Research Network


Clinical Research Operations and Management System (CROMS)

Clinical Research Operations & Management System (CROMS)

  • CROMS Purpose:
    • Provide institute-wide informatics capability to track, report, and manage NIA's clinical enrollment data, activities, and grant portfolio in near real-time
      • All NIA clinical trials and studies that enroll human subjects

Why an NIA-wide clinical research IT system?

  • Institutional Accountability for Research
  • Operational Portfolio Management
  • Data Management


  • Project began in July 2020
    • Competitively bid
    • Awarded to Digital Infuzion (experience with NIAID, NCI, NIDCR)
  • Currently on schedule, despite the many challenges COVID posed
  • First fully operational release scheduled for July 2021
    • Will address AD/ADRD clinical trials
  • Following, will add remaining trials and studies in the NIA portfolio

CROMS Components & Features

Screen shot of CROMS webpage.

Dashboard Mockups -- Overarching View

Screen shot of CROMS webpage.

Dashboard Mockups -- Study-Specifics

Screen shot of CROMS webpage.

Dashboard Mockup -- Site Performance

Screen shot of CROMS webpage.


Increase Awareness of AD/ADRD Clinical Research

Well-tested Community Outreach Materials for Minority Populations


  • Develop AD/ADRD clinical research materials specific to the language and cultural needs of minority populations
    • Design of a suite of recruitment outreach materials for minority groups:
      1. African Americans (2019)
      2. Latinos (2020)
      3. Asian American & Pacific Islanders (2021)
      4. Native Americans (2022)
    • Materials can be tailored and branded by local community organizations

Process follows health communication best practices

  • Outreach Materials Development and Testing
    • Conduct qualitative and quantitative research to develop and refine a suite of outreach materials tailored to increase the participation and retention of minority populations in AD/ADRD clinical studies.
    • Materials include: Leave-Behinds, Fact Sheets, Image Library, Videos, Social Media Posts, and Motion Graphics
Road map of information.


Screen shots of African American Audience and General Audience material. Screen shots of Hispanic Audience material.
* Currently working with Asian American and Pacific Islander (AAPI) stakeholders to develop a third suite by September 2021

Moving the Needle: African American Research Results

Bar Chart, Change in Likelihood to Consider a Clinical Trial; compares information Before Ads and After Ads: Not interested at all 11%, 8%. Not too interested 19%, 14%. Somewhat interested 34%, 30%. Very interested 19%, 23%. Extremely intersted 17%, 24%. Line Chart, Mean Change in Likelihood to Consider a Trial by Group; compares information Healthy, At-Risk, Caregiver as of Before Ads and After Ads.
All group increases are significant at p < .001

Moving the Needle: Latino Research Results

Bar Chart, Change in Likelihood to Consider a Clinical Trial; compares information Before Ads and After Ads: Not interested at all 11%, 3%. Not too interested 23%, 10%. Somewhat interested 34%, 38%. Very interested 21%, 30%. Extremely intersted 11%, 19%. Line Chart, Mean Change in Likelihood to Consider a Trial by Group; compares information Healthy, At-Risk, Caregiver as of Before Ads and After Ads.
All group increases are significant at p < .001

Outreach Pro: NIA's Tool for Clinical Studies Recruitment and Education

Outreach Pro: NIA's Online Tool for Clinical Studies Recruitment and Education

Screen shot of NIA webpage to Optimize Recruitment for Your Study.


  • Provide community stakeholders access to well-tested, evidence-based AD/ADRD clinical research materials and strategies in an easy-to-use web-based communication tool
    • Users answer a brief set of questions specific to their audiences of interest
    • Tool produces a “package” of tailored materials and strategies that can be branded locally for the end-user's community.

Outreach Pro

  • Online tool allows the research community to access, adapt, and personalize the materials that NIA has developed and tested for underrepresented communities through a user-friendly step-by-step process:
Step-by-step screen shots to information.


Plans for a Community Practitioner Research Network

NIA Substantial Investments to Support Clinical Research

  • Including:
    • Alzheimer's Clinical Trials Consortium (ACTC)
    • Trial Ready Cohort for the Prevention of Alzheimer's Dementia (TRC-PAD)
    • Alzheimer's Disease Research Centers (ADRCs)
    • Resource Centers for Minority Aging Research (RCMAR)
    • NIA Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory
    • R24: Examining Diversity, Recruitment and Retention in Aging Research
    • Others...

Geographic Distribution of AD/ADRD by Minority Populations

ADRD County-Level Prevalence
Blacks, Hispanic/Latinos, Asian Americans, and North American Natives
Medicare Fee for Service, 2016
United States Map showing the NIA ADRC and ACTC Sites and their Prevalence.
Map Generated by National Alzheimer's Disease Index Powered by USAgainstAlzheimer's

Question: How can we better enroll minorities?

  • We do not adequately recruit minority participants commensurate to the disease impact
  • NIA has programs and research sites across the U.S., though with potential geographic 'gaps' where minorities affected by AD live but have limited/no infrastructure
  • Literature continues to report on AD/ADRD clinical research challenges with accessing minority community participation

Conclusion: Our current efforts and resources are important and necessary, but insufficient

  • No matter how hard our current system works to address the inclusion of minorities, it will be difficult to address the gaps

Premise: Go to where the participants live vs. asking participants to come to us

  • Build a community infrastructure of PIs and sites in minority communities with high rates of AD/ADRD
  • Select sites where doctors/staff have a research interest and relevant expertise
  • Nurture and incentivize community sites directly to conduct research

Complement our current resources:

  • Academic Medical Centers
  • Community Practitioner Sites
  • Programs and Registries

NIH ICs with Community-Based Research Networks

IC Network Description
NEI DRCR Retina Network 160 physician offices with over 500 physicians throughout the United States and Canada to conduct high quality, collaborative clinical research
NIDCR National Dental Practice-Based Research Network (PBRN) Over 6,500 dental clinicians conduct research on patient health outcomes, patient satisfaction, or the efficiency of the daily delivery of care.
NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) Treatment researchers and community-based substance abuse service providers cooperatively develop, validate, refine, and deliver new treatment options to patients.
NCI NCI Community Oncology Research Program (NCORP) Comprised of 7 Research Bases and 46 Community Sites--14 designated as Minority/Underserved Community Sites--that accrue individuals to NCI-approved cancer clinical trials and research studies.
NHLBI Pulmonary Trials Cooperative (PTC) Provides a framework for research leaders to work with a pool of major medical centers and community-based medical providers.
NINDS Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Enrollment is conducted in diverse patient populations and practice environments including academic medical centers and community ER hospitals to ensure that results can be generalized.
NINDS StrokeNet ~500 US hospitals conduct small and large clinical trials and research studies to advance acute stroke treatment, stroke prevention, and recovery
NIAID HIV/AIDS Clinical Trials Networks Four publicly-funded network collaborations of community and academic sites around the world to address NIAID's five HIV/AIDS scientific priorities

NCI Community Oncology Research Program (NCORP)

North American Map showing sites for the NCORP program.

NCI Minority-based Sites' Accrual Contribution

Line Chart showing the Minority percentage of patients accrued to NCI's Phase 3 treatment trials by NCI's minority-based sites versus other community sites and large academic sites.
Fig 2. Minority percentage of patients accrued to cooperative group treatment trials by Minority-Based Community Clinical Oncology Programs (MBCCOPs), other Community Clinical Oncology Programs (CCOPs), and non-CCOP members/affiliates. Non-CCOP members of cooperative groups include academic medical centers, National Cancer Institute--designated cancer centers, and other large research institutions. Affiliates include community hospitals and oncology practices that affiliate with cooperative groups through "main memnber" institutions.
J Clin Oncol 23:5247-5254, 2004.

Next Steps

  1. Internal NIA Community Practitioner Research Network Committee
    • Meeting regularly to identify needs, define vision, propose strategy
  2. Input from the Field: One-day Community Practitioner Research Network Symposium
    • Virtual meeting in early April 2021 (tbd), 12-5 pm EST
    • Invite stakeholders from around country to participate in a discussion exploring potential models for a NIA community practitioner research network

Thank you!


National Institute on Aging

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Advisory Council on Alzheimer's Research, Care, and Services Page

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