Research Priorities and Approaches

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Research Priorities and Approaches

ATHN Data Summit 2008August 1, 2008Presenter: Thomas Abshire, M.D.

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Objectives

• Report on ATHN’s current research strategy and progress to date

• Explore potential next steps to develop capacity

– Within ATHN

– At ATHN Affiliate HTCs

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ATHN’s Strategic Direction

Network Infrastructure

Data Management

Public Health and Safety

Outcomes Improvement

Data Analysis and Research

Data safety, back-up, and portability

Support surveillance and patient safety

Use data to drive quality, service, and patient centered care

Facilitate knowledge creation and advocacy

Develop electronic database capacity

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ATHN’s Strategic Opportunities

•Establish in 2009 with ATHN Affiliates and collaborating organizations (especially HTRS) ATHN’s research agenda over a five year horizon

•Launch one research initiative in conjunction with HTRS by 2010

•Develop guidelines for publication

Data Analysis and Research

Facilitate knowledge creation and advocacy

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How Is ATHN Helping Today?

• Providing infrastructure

– Electronic database in development

– Standardized data elements

– Funding for data entry personnel ($400,000 in round one)

• Cooperating and facilitating shared projects

– Project Review Panel

• Exploring merger with HTRS

– Combined strength

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ATHN Project Review Process

• Written submission

• Multi-disciplinary review

• Timely 30 day review

• Approved projects posted on ATHN website

2008 Committee

Jeanne Lusher (chair)Jorge Di PaolaMaggie Ragni

Judith AndersonLaurel Mc KernanMadhvi Rajpurkar

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ATHN Project Review Process

Until a data base exists:• Put “on hold”

Or • Forward to UDC Working

Group

Assess if the project:• Protects confidentiality• Fits ATHN’s mission• Has credible purpose and

design• Helps ATHN build internal

capacity• Has reasonable

requirements• Is financially self-sustaining

Approve or Not

Database Study Other Project

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Sample Projects – Just Starting

• Plasminogen Registry

– HTC investigator initiated project

– ATHN contracted to support the creation and implementation of an electronic registry

– Funding available

• CHAVI (Center for HIV/AIDS Vaccine Immunology)

– NIH supported study in hemophilia patients

– Site recruitment in the U.S. needed

– Project review panel viewed as worthwhile

– Capacity building for ATHN

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Real Need is Greater

• Study sponsors need/want help to coordinate studies in the U.S.

– Designing, enrolling, collecting clean data, tracking

• HTCs desire help to streamline implementation

– IRB, patient recruitment, data collection, funding

• Non-federally funded sites and practitioners may have patients for important studies

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How Will the ATHN Database and Electronic Infrastructure Support Research?

Database Result

Patient demographic, disease & treatment data

•More informed study design

•Identification/enrollment of patients matching study criteria

Electronic infrastructure•Less redundant, more accurate data collection

•Tracking patient consents

More synthesized cohort data

•Better & faster hypothesis development

•Ability to track the impact of an intervention on care outcomes

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How Will the ATHN Network Infrastructure Support Research?

Network Result

Subject Matter Experts•Advice in study design and data endpoints

Communication Vehicles•Newsletter, email blasts, web postings to communicate study opportunities to ATHN Affiliates

Standardization and Centralized Coordination

•Operational efficiencies conserve precious resources

•Templates streamline workload

•Synergies allow ATHN to attract funding

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Process

Templates

Communication &Training

Network

ATHN Staff

Technology

ATHN Capacity Building

Capacity Building Is Required Over Time

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Process

Templates


Network

ATHN Staff

Technology


Capacity Building:Technology

•Lab Tracker Web•Standardized terms •Patient consent flag

•Web portal

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Process

Templates


Network

ATHN Staff

Technology


Capacity Building: Processes

•Pre-populated case reports

•CDC analytic support

•Central IRB

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Process

Templates


Network

ATHN Staff

Technology


Capacity Building:Templates

•IRB submission•Patient consents

•Study progress

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Potential Affiliate Categories

• Level 1 – Collects core data and may propose database studies

• Level 2 – Quality of the site’s database has been validated by a clinical monitor

• Level 3 – Meets minimum requirements to serve as a clinical research study site(e.g., human subjects training completed, access to IRB, investigator CV and Form 1572 on file, etc.)

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Research Agenda: View to the Future

• Database studies using ATHN database

– Rare coagulation disorders; thrombophilia

• Investigator initiated studies

– Physicians, nurses, PTs, LSWs, etc.

• Pharmaceutical industry trials

– New drug products; new assays

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Study Sponsor of a Potential Research Project

CDC HTC

ATHN Affiliates & Others

Study Sponsor

CDC staff/Working Group

Active tracking & other services

Broadcast or Focused recruitment

Aggregate UDC Data

Research Priorities and Approaches

Documents

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