Clinical Trials and IMPAACT: Clinical Trials and IMPAACT:

Technological Challenges Technological Challenges and Strategic Opportunitiesand Strategic Opportunities

Today’s AgendaToday’s Agenda

IMPAACT OverviewIMPAACT Overview Technological ChallengesTechnological Challenges

-- Data ManagementData Management-- TelecommunicationsTelecommunications-- TranslationTranslation-- “Change” Management“Change” Management

Strategic OpportunitiesStrategic Opportunities SummarySummary

IMPAACT NETWORK: MISSION

To prevent and treat HIV in infants, children, adolescents and pregnant women domestically and internationally

IMPAACT NIAID Sites IMPAACT NIAID Sites

IMPAACT NICHD SitesIMPAACT NICHD Sites

IMPAACT NIAID Site FundingIMPAACT NIAID Site Funding

Fully Funded - 7 year funding cycleFully Funded - 7 year funding cycle

Provisional – reviewed annuallyProvisional – reviewed annually

Protocol Specific – to conduct 1 protocolProtocol Specific – to conduct 1 protocol

IMPAACT PROTOCOLS

Open to accrual – 14 protocolsOpen to accrual – 14 protocols

Closed to accrual, but open – 10 protocolsClosed to accrual, but open – 10 protocols

In development – 15 protocolsIn development – 15 protocols

as of 5/12/08

Research AgendaResearch Agenda

ComplicationsScientific Committee

ComplicationsScientific Committee

Vaccine and Immuno-based

TherapyScientific Committee

Vaccine and Immuno-based

TherapyScientific Committee

Women’s HealthInter-Network

ScientificCommittee

Women’s HealthInter-Network

ScientificCommittee

PMTCT Scientific Committee

PMTCT Scientific Committee

PrimaryTherapy

ScientificCommittee

PrimaryTherapy

ScientificCommittee

IMPAACTIMPAACT

Technological ChallengesTechnological Challenges

Data ManagementData Management-- DAIDS-ES system is at the beginning DAIDS-ES system is at the beginning

of implementationof implementation-- Coordination of data transfers to Coordination of data transfers to DAIDS-ES systemDAIDS-ES system-- Working with newer sites to developWorking with newer sites to develop

infrastructure through ongoing traininginfrastructure through ongoing training-- Standardize cost methodology Standardize cost methodology throughout the Networkthroughout the Network

Technological ChallengesTechnological Challenges Telecommunication/Communication IssuesTelecommunication/Communication Issues

-- Conference calls and web-based mediums Conference calls and web-based mediums are the main sources of communication are the main sources of communication

for for the IMPAACT Networkthe IMPAACT Network---- An estimated 1,025 conference An estimated 1,025 conference

calls annually – using two differentcalls annually – using two differenttelecommunications networkstelecommunications networks

-- Restructuring the current IMPAACT Restructuring the current IMPAACT web-site to include communication web-site to include communication portalsportals-- Creating an IMPAACT Newsletter Creating an IMPAACT Newsletter

Technological ChallengesTechnological Challenges

Translation Translation -- Need is most critical in our Americas Need is most critical in our Americas

region – Domestic U.S., Brazil, region – Domestic U.S., Brazil, Argentina, and Puerto RicoArgentina, and Puerto Rico

-- Portuguese, Spanish-- Portuguese, Spanish-- Limited translation capacity for sites Limited translation capacity for sites in in Thailand and IndiaThailand and India-- Africa sites could use Swahili to Africa sites could use Swahili to maximize group participationmaximize group participation

Technological ChallengesTechnological Challenges

Managing the process of “Change” Managing the process of “Change” throughout the IMPAACT Networkthroughout the IMPAACT Network-- Leveraging fewer dollars each year Leveraging fewer dollars each year

within and outside of the Networkwithin and outside of the Network-- Recognizing and addressing cultural Recognizing and addressing cultural

differences across the Networkdifferences across the Network---- IMPAACT was the merger of IMPAACT was the merger of

two two previously existing Networkspreviously existing Networks---- International and domestic sitesInternational and domestic sites

Strategic OpportunitiesStrategic Opportunities

Strengthen and further develop our data Strengthen and further develop our data management capabilitiesmanagement capabilities

Expand translation to increase Network Expand translation to increase Network participationparticipation

Enhance telecommunications capabilities to Enhance telecommunications capabilities to maximize communication throughout the maximize communication throughout the NetworkNetwork

Develop strategic alliances with other Networks Develop strategic alliances with other Networks and create partnerships with external groups to and create partnerships with external groups to leverage limited resourcesleverage limited resources

SummarySummary

IMPAACT Network has survived the first IMPAACT Network has survived the first several years of operation creating a solid several years of operation creating a solid foundation for growthfoundation for growth

Technological challenges are addressed Technological challenges are addressed with innovative, cost-effective solutionswith innovative, cost-effective solutions

The Network has adapted to the reality of The Network has adapted to the reality of limited resources by forming new strategic limited resources by forming new strategic partnershipspartnerships