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Clinical trials: Harmonisation and Cooperation Feedback on session

Clinical trials: Harmonisation and Cooperation Feedback on session. Lew Barker & Michele Tameris. Blueprint March 2012. Determine TB prevalence and incidence, select trial sites and choose target populations.

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Clinical trials: Harmonisation and Cooperation Feedback on session

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  1. Clinical trials: Harmonisation and CooperationFeedback on session Lew Barker & Michele Tameris

  2. Blueprint March 2012 • Determine TB prevalence and incidence, select trial sites and choose target populations

  3. Design clinical trials with appropriate endpoints for determining an acceptable efficacy in different target populations

  4. Address regulatory and ethic issues and plan for post licensure sustainability

  5. Key questions: • Best clinical strategies to demonstrate prevention of reactivation of LTB • Can vaccines effectively reduce Mtb transmission? • How can various organisations in endemic areas share site infrastructure • Best strategies for studying therapeutic vaccines

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