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Bench to patient in record time; Conducting trials in the Ebola outbreak

This article discusses the importance of rapid and coordinated clinical research response to infectious disease outbreaks, using the Ebola outbreak as an example. It highlights the key milestones and challenges faced in conducting trials during the outbreak and emphasizes the need for proactive preparedness. The article also addresses Bill Gates' concerns about the likelihood of a widespread epidemic and the role of clinical research in mitigating such risks.

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Bench to patient in record time; Conducting trials in the Ebola outbreak

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  1. Bench to patient in record time;Conducting trials in the Ebola outbreak Professor Trudie Lang, University of Oxford

  2. Rapid research response

  3. Rapide Platform Target Product Profile

  4. Rapide BCV Trial Key Milestones Grant awarded to study start = 4months

  5. The Epidemic and research Monthly new cases Total cases 21,000 March 14 Nov - Dect14 Jan 15 Sept 14 Lost 6 weeks Grant awarded First patient

  6. Clinical research responses to ID outbreaks are usually fragmented and too late Infectious disease outbreak time Clinical Research Response Preclinical Research Response Public Health Response

  7. What is Bill Gates Afraid Of? "I rate the chance of a nuclear war within my lifetime as being fairly low," says Gates. "I rate the chance of a widespread epidemic, far worse than Ebola, in my lifetime, as well over 50%.”

  8. Outbreak Mode 3 GA decision, EC (tacit) approval Outbreak Research Response Mode * 2 Outbreak Research Mobilisation Mode • Outbreak Research Team (ORT): • PREPARE Executive Board; • ad-hoc PREPARE experts; • Ad-hoc external experts if necessary; GA decision, EC (tacit) approval * • Outbreak Research Team (ORT): • PREPARE Executive Board; • ad-hoc PREPARE experts; 1 Outbreak Research Preparation Mode Outbreak Research Team (OTC) Ad-hoc PREPARE expert committee Outbreak Research Plan: Outbreak Research Plan: Planning and implementation of preparatory work necessary to achieve operational readiness to initiate clinical research response to specific ID outbreak if and when needed. Planning and implementation of clinical research response to specific ID outbreak, building on the generic clinical research activities and preparedness activities in PREPARE. Assessing operational readiness in the network and development of clinical protocol if needed * * * * * GA decision, EC (tacit) approval GA decision, EC (tacit) approval GA decision, EC (tacit) approval * 0 Outbreak Mode Committee (OMC): Standing committee that convenes when the Coordinator is contacted in relation to a new specific ID outbreak to discuss the appropriate Outbreak Mode (1, 2 or 3) Composition: Herman Goossens (Chair), Menno de Jong, Marion Koopmans, Peter Horby Inter-Epidemic Mode

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