# Presentation: 896821

## Creation of a national volunteer for research web portalNational Advisory Research Resources CouncilFebruary 12, 2009

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

## Agenda

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

## Recruitment Needs Assessment

## 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

## 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

## 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)

## Vanderbilt Local Registry (Case Study)

## Consumer Site:  Clinical Studies

- _Key Elements_
**Consumer Education**
- Find a Study
- Recruitment Registry (for prospective consideration)

## Consumer Site:  Clinical Studies

- _Key Elements_
- Consumer Education
**Find a Study**
- Recruitment Registry (for prospective consideration)

## Consumer Site:  Clinical Studies

- _Key Elements_
- Consumer Education
- Find a Study
**Recruitment Registry**** (for prospective consideration)**

## 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

## 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

## 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**

## Recruitment Registry Utilization

## Consumer Site Traffic

- Unsolicited Domestic Traffic: 08/04/2008 – 02/04/2009	8,780 Visits from 1,080 Geographical Areas

## 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

## National Registry Model

## Preliminary Section - Under Review

- Registry + Clearing house

**Preliminary Section - Under Review**

## 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

## CTSA Participation Model         and Regulatory Oversight

## 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

## Regulatory Oversight

- Vanderbilt IRB responsible for all human subject protections for the national registry
- Vanderbilt IRB will make ‘packet information’ available to each site’s liaison
- Meeting minutes
- Metrics
- Usage
- Continuing review information
- Complaints

## Progress Report

## Target Timeline

## CTSA Stakeholder MeetingVanderbilt 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)

## Questions?