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Harmonization and Cooperation in TB Clinical Trials: A Blueprint for Effective Strategies

This document outlines key strategies for harmonizing and cooperating in tuberculosis (TB) clinical trials. It focuses on critical aspects such as determining TB prevalence and incidence, selecting trial sites, and identifying target populations. It emphasizes the design of clinical trials with appropriate endpoints to evaluate efficacy, addresses regulatory and ethical concerns, and discusses plans for post-licensure sustainability. Key questions explored include strategies to prevent the reactivation of latent TB, the effectiveness of vaccines in reducing Mtb transmission, and collaborative site infrastructure among organizations in endemic regions.

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Harmonization and Cooperation in TB Clinical Trials: A Blueprint for Effective Strategies

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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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