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

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

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

IMPAACT NIAID Sites

IMPAACT NICHD Sites

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

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

Research Agenda Complications Scientific Committee Complications Scientific Committee Vaccine and Immuno-based Therapy Scientific Committee Vaccine and Immuno-based Therapy Scientific Committee Women’s Health Inter-Network Scientific Committee Women’s Health Inter-Network Scientific Committee PMTCT Scientific Committee PMTCT Scientific Committee Primary Therapy Scientific Committee Primary Therapy Scientific Committee IMPAACT

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

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

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

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

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

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