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Clinical Trials and IMPAACT: Technological Challenges and Strategic Opportunities

Clinical Trials and IMPAACT: Technological Challenges and Strategic Opportunities. Today’s Agenda. IMPAACT Overview Technological Challenges - Data Management - Telecommunications - Translation - “Change” Management Strategic Opportunities Summary. IMPAACT NETWORK: MISSION.

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Clinical Trials and IMPAACT: Technological Challenges and Strategic Opportunities

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  1. Clinical Trials and IMPAACT: Technological Challenges and Strategic Opportunities

  2. Today’s Agenda • IMPAACT Overview • Technological Challenges - Data Management - Telecommunications - Translation - “Change” Management • Strategic Opportunities • Summary

  3. IMPAACT NETWORK: MISSION To prevent and treat HIV in infants, children, adolescents and pregnant women domestically and internationally

  4. IMPAACT NIAID Sites

  5. IMPAACT NICHD Sites

  6. IMPAACT NIAID Site Funding • Fully Funded - 7 year funding cycle • Provisional – reviewed annually • Protocol Specific – to conduct 1 protocol

  7. IMPAACT PROTOCOLS Open to accrual – 14 protocols Closed to accrual, but open – 10 protocols In development – 15 protocols as of 5/12/08

  8. PrimaryTherapy ScientificCommittee PMTCT Scientific Committee Complications Scientific Committee IMPAACT Women’s Health Inter-Network Scientific Committee Vaccine and Immuno-based Therapy Scientific Committee Research Agenda

  9. Technological Challenges • Data Management - DAIDS-ES system is at the beginning of implementation - Coordination of data transfers to DAIDS-ES system - Working with newer sites to develop infrastructure through ongoing training - Standardize cost methodology throughout the Network

  10. Technological Challenges • Telecommunication/Communication Issues - Conference calls and web-based mediums are the main sources of communication for the IMPAACT Network -- An estimated 1,025 conference calls annually – using two different telecommunications networks - Restructuring the current IMPAACT web-site to include communication portals - Creating an IMPAACT Newsletter

  11. Technological Challenges • Translation - Need is most critical in our Americas region – Domestic U.S., Brazil, Argentina, and Puerto Rico -- Portuguese, Spanish - Limited translation capacity for sites in Thailand and India - Africa sites could use Swahili to maximize group participation

  12. Technological Challenges • Managing the process of “Change” throughout the IMPAACT Network - Leveraging fewer dollars each year within and outside of the Network - Recognizing and addressing cultural differences across the Network -- IMPAACT was the merger of two previously existing Networks -- International and domestic sites

  13. Strategic Opportunities • Strengthen and further develop our data management capabilities • Expand translation to increase Network participation • Enhance telecommunications capabilities to maximize communication throughout the Network • Develop strategic alliances with other Networks and create partnerships with external groups to leverage limited resources

  14. Summary • IMPAACT Network has survived the first several years of operation creating a solid foundation for growth • Technological challenges are addressed with innovative, cost-effective solutions • The Network has adapted to the reality of limited resources by forming new strategic partnerships

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