Creation of a national volunteer for research web portal National Advisory Research Resources Counci

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Creation of a national volunteer for research web
portalNational Advisory Research Resources
CouncilFebruary 12, 2009

• Paul Harris, PhD
• Director, CTSA Informatics Operations
• Department of Biomedical Informatics
• Vanderbilt University

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Agenda

• Recruitment Needs Assessment
• Vanderbilt Local Registry (Case Study)
• National Registry Model
• CTSA Participation Model and Regulatory
  Oversight
• Progress Report

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Recruitment Needs Assessment
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Participant Recruitment ? Barrier to the
Efficiency of Clinical and Translational Research

• Difficult to efficiently identify and enroll
  participants, which
• frustrates investigators
• can result in statistically underpowered studies
• slows the pace of translation
• CTSA RFA lists recruitment strategies as an
  important common issue

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National Recruitment Registry Maps to CTSA
PI-Defined National Strategic Priorities

• Enhancing national clinical and translational
  research capability
• Enhanced and standardized clinical research
  management
• Improved research infrastructure
• phenotyping - human and preclinical models
• Enhancing the training and career development of
  clinical and translational scientists
• Enhancing consortium-wide collaborations
• social networking
• inventory of resources
• data sharing
• Enhancing the health of our communities and the
  nation
• community engagement
• public health policy

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Benefits National Recruitment Registry

• Researchers
• Provides a database of people already interested
  in participating
• Registry ? Study Exposure ? ? Enrollment and
  ?Study Duration
• Potential Participants
• Self-guided exposure to research
• Practical help in finding research opportunities
  across institutions
• CTSA Institutions (later any institution)
• Cost-effective resource for local researchers
• Opportunities tools for studying recruitment
  methods (research on research)
• Society
• Speeds approval of effective therapies
• Every taxpayer can participate (regardless of
  geographical location)

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Vanderbilt Local Registry (Case Study)
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Consumer Site Clinical Studies

• Key Elements
• Consumer Education
• Find a Study
• Recruitment Registry (for prospective
  consideration)

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Consumer Site Clinical Studies

• Key Elements
• Consumer Education
• Find a Study
• Recruitment Registry (for prospective
  consideration)

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Consumer Site Clinical Studies

• Key Elements
• Consumer Education
• Find a Study
• Recruitment Registry (for prospective
  consideration)

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Recruitment Registry - Researcher Site

• Consumers
• Self-enter information consenting to contact from
  VU researchers for IRB-approved studies access
  via Consumer Site
• Researchers
• Search/Filter Tools
• Contact Tools
• Researcher Access Policy
• Completed Data Use Agreement
• IRB-Approved Study

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Recruitment Registry - Researcher Site

• Consumers
• Self-enter information consenting to contact from
  VU researchers for IRB-approved studies access
  via Consumer Site
• Researchers
• Search/Filter Tools
• Contact Tools
• Researcher Access Policy
• Completed Data Use Agreement
• IRB-Approved Study

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Registry Access Researcher DUA

• Consumers
• Self-enter information consenting to contact from
  VU researchers for IRB-approved studies access
  via Consumer Site
• Researchers
• Search/Filter Tools
• Contact Tools
• Researcher Access Policy
• Completed Data Use Agreement
• IRB-Approved Study

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Recruitment Registry Utilization
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Consumer Site Traffic
Unsolicited Domestic Traffic 08/04/2008
02/04/2009 8,780 Visits from 1,080 Geographical
Areas
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Local Registry Lessons Learned

• The model works
• Potential participants will self-enter
  information in a registry and are actively
  looking for opportunities to participate in
  studies
• Researchers have proven capable of using
  self-service tools to search/contact potential
  participants
• Self-service model easy to manage (limited
  administrative support)
• No major problems in six years of operation
• Enhancements will make it even more useful
• Model needs refinement for evaluation and full
  metrics reporting
• Placement is critical. Co-location of the
  registry with a public site listing available
  studies brings in additional volunteer registrants

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National Registry Model
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Registry Clearing house
Preliminary Section - Under Review
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Consumer Site Framework

• Institution-neutral domain name
• Co-locate registry with listings of registered
  studies known to be recruiting
• Leverage ClinicalTrials.gov data to automatically
  suggest potential studies outside CTSA domain

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CTSA Participation Model and Regulatory
Oversight
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CTSA Participation Model

• Each participating CTSA will appoint a liaison
• Liaison responsibilities
• Local IRB awareness/agreement of program and
  methods/protections
• Electronic promotional announcements to populate
  registry in local area
• Gatekeeper and point of contact for local
  researchers
• PI communications to build utilization

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Regulatory Oversight

• Vanderbilt IRB responsible for all human subject
  protections for the national registry
• Vanderbilt IRB will make packet information
  available to each sites liaison
• Meeting minutes
• Metrics
• Usage
• Continuing review information
• Complaints

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Progress Report
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Target Timeline
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CTSA Stakeholder MeetingVanderbilt University,
Dec 16, 2008
Each CTSA invited to send one individual with
recruitment experience and institutional backing
to serve as a liaison for the project. Full Day
Meeting 43 Attendees from NCRR and 24 CTSA
Institutions CTSA Commitments 31/38
Institutions have named a liaison as of Feb 12,
2009.
Meeting Attendees (Dec 16, 2008)
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Questions?