Advisory Council February 2017 Meeting Presentation: Transforming National Recruitment Strategy



Friday, February 3, 2017

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National Recruitment Strategy: Lessons Learned, Innovation and the Way Forward

GAP Mission and Strategy

  • Mission: To reduce Alzheimer's clinical trial cycle times by up to two years
  • Strategy:
    • Speed trial start-up through a standing, high performance network of certified trial sites utilizing standardized processes, contracting, staff training and national IRB
    • Increase volume and efficiency of participant recruitment across all trials, studies, sponsors, and disease stages
    • Build local capacity through community-based, site-centric program
    • Engage communities through integrated political, business, media and site systems
    • Embed clear minority recruitment goals and minority-friendly referral programs
    • Engage health systems and primary care physicians
    • Set clear site and network performance metrics ... measure ... innovate ... repeat

Improving Internet Recruitment Technology

  • Conducted a year-long pilot with Brain Health Registry to test social media based recruitment campaign, measured in five markets
  • Collecting data on cost of acquisition throughout recruitment process
  • Identified impediments that led to planned improvements in both BHR and GAP digital strategies
  • Finalizing development of GAP's digital approach -- an open source, interoperable database embedded in site-centric, community based approach
Type of Member # Members Cost/Acquisition
Total BHR Membership/GAP 7,623 $73
Referral Candidates
# Possibly Impaired 233 $2,403
# Cognitively Normal 843 $664
Awaiting Cog Test Results 165 $3,394
No Cog Tests 2,145 $261
Referred to Studies
Referred 1,711 $327
Responded 342 $1,637
Interested 209 $2,679
Screened by Site Staff 90 $6,222
Eligible 53 $10,566
Enrolled On-going TBD

2016 Economics of Recruiting Are Challenging

To recruit the estimated 4,500 participants needed for a range of oncoming preclinical/prodromal trials, if dependent on current Internet registry techniques, nearly 7 million people may need to be contacted

Funnel Chart: 6,750,000 Participants; 675,000 Participants Referred; 27,000 Participants Screened; 22,500 Participants Needed.


What is the nature and size of the problem?

  • Set goals that 'fit' the problem
    • Size of participant population needed by stage of disease
    • Inclusive of minorities
    • Participant-oriented and participant-friendly
    • Sponsor, academic/commercial site and trial/study neutral
    • Ensure sites have the capacity to assess increased recruits in timely fashion
  • Set tactics that are well-targeted and appropriately-scaled
    • Community and site centric -- all recruitment is local
    • Performance and metric oriented
    • Collaborative--incentivize data sharing and interoperability of databases to improve participant access
  • Innovate > measure > report> repeat

Investing in Local Research Sites

  • Invested $100k in 11 pilot sites in GAP-Net site network
  • Sites that hired a dedicated local recruiter for all trials saw an increased enrollment of nearly 43%
  • Cost per randomized participant at pilot sites: $1,500
  • Investment in new initiative at KU yielded 160% year over year increase in referrals
  • Other key impacts of investments:
    • Technology enhancements, including targeted recruitment via GIS
    • Specialized outreach/advertisements e.g., TV ads
    • Site participation in additional studies
  • Network now includes 45 U.S. and Canadian sites (26 academic, 19 private)
  • Sites must meet quality and performance metrics informed by pilot results

Novel Recruitment Approach

Site-centric, community-based approach: a collaboration between research sites, health systems, large local employers, and community leaders

  • GAP-Net Site: Enroll participants, conduct trials, provide process-improving data more quickly and cost effectively
  • Payer and Provider Network: Identify and recruit participants through HCPs/payer networks and their marketing channels
  • Minority Community: Integrate health/social networks serving underrepresented populations
  • Federal, state, and local government: Catalyze community awareness and employees'/beneficiaries' participation
  • Local Fundraising: Develop matching local funding sources

Role of Council: Integrating Efforts, Setting Goals

  • National challenge, national community-based response
    • Patients want faster cures, communities feeling the pain, sites feeling the strain
    • Public and private sponsors and clinical researchers want greater capacity
    • Prevention trials present a particular challenge
    • Grow percentage of minorities participating in trials year-over-year
  • Integrate National Initiatives: ACTC, NCATS (RICS/TICS), National Recruitment Initiative, GAP
  • Innovation goals:
    • Key performance indicators: national trial capacity; cost/enrollment; number of participants in trials/studies
    • Increase number of AD trial participants to x% of estimated affected population (UK)
    • Expand application of technologies -- including mobile -- for trial recruitment and inclusion in protocols
    • Develop site-centric, community-based recruitment programs in 100 locations by 2020
  • Beyond Alzheimer's: Citizen Participation in Research
    • 50% of American families participating in clinical research by 2025

Need for Inter-Agency Collaboration

  • NIH -- Spearhead effort across Institutes (NIA, NCATS, NIMHD, NINDS); report and reward effectiveness of recruiting underrepresented populations
  • CDC -- Raise awareness of AD, early diagnosis, clinical research value ('first person cured of Alzheimer's will be in a clinical trial'); report concentration of AD patients by county
  • CMS -- Establish reimbursement guidelines (e.g., Star Ratings and HCC weightings) to incentivize physician assessment and support of research
  • FDA -- Foster innovation in clinical trial design; big data/biomarkers; give AD therapies breakthrough status
  • IHS -- Offer clinical trial resources to underserved Native American populations
  • VA -- Increase veterans' access to research opportunities

The First Person Cured of Alzheimer's Will Be in a Clinical Trial

Thank You

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