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Research Priorities and Approaches

Research Priorities and Approaches. ATHN Data Summit 2008 August 1, 2008 Presenter: Thomas Abshire, M.D. 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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Research Priorities and Approaches

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  1. Research Priorities and Approaches ATHN Data Summit 2008 August 1, 2008 Presenter: Thomas Abshire, M.D.

  2. 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

  3. ATHN’s Strategic Direction Network Infrastructure Data Management Public Health and Safety Outcomes Improvement Data Analysis and Research Develop electronic database capacity 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

  4. 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

  5. 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

  6. Written submission Multi-disciplinary review Timely 30 day review Approved projects posted on ATHN website ATHN Project Review Process 2008 Committee Jeanne Lusher (chair) Jorge Di Paola Maggie Ragni Judith Anderson Laurel Mc Kernan Madhvi Rajpurkar

  7. 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 ATHN Project Review Process DatabaseStudy Other Project

  8. 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

  9. 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

  10. How Will the ATHN Database and Electronic Infrastructure Support Research?

  11. How Will the ATHN Network Infrastructure Support Research?

  12. Capacity Building Is Required Over Time

  13. Capacity Building: Technology • Lab Tracker Web • Standardized terms • Patient consent flag • Web portal

  14. Capacity Building: Processes • Pre-populated • case reports • CDC analytic • support • Central IRB

  15. Capacity Building: Templates • IRB submission • Patient consents • Study progress

  16. Capacity Building: Communications • Study announcements • Password protected • website to post docs • Investigator meetings

  17. Capacity Building • HTC investigators • HTC clinicians • Others

  18. Capacity Building: ATHN Staff • Trained local • data managers • Clinical monitor

  19. 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.)

  20. 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

  21. Study Sponsor of a Potential Research Project CDC HTC Aggregate UDC Data CDC staff/ Working Group Active tracking & other services Broadcast or Focused recruitment ATHN Affiliates & Others Study Sponsor

  22. Your Advice Please… • Top capacity building priorities • ATHN Affiliate levels • Research agenda

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