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ISARIC/WHO BIOLOGICAL SAMPLING PROTOCOL

ISARIC/WHO BIOLOGICAL SAMPLING PROTOCOL. www.prognosis.org/isaric. Ken Baillie MD PhD, Chair, Genetics, Pathogenesis and Pharmacology Working Group, International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). The problem.

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ISARIC/WHO BIOLOGICAL SAMPLING PROTOCOL

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  1. ISARIC/WHO BIOLOGICAL SAMPLING PROTOCOL www.prognosis.org/isaric Ken Baillie MD PhD, Chair, Genetics, Pathogenesis and Pharmacology Working Group, International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC)

  2. The problem • Emerging pathogens (MERS CoV, H7N9 influenza, H5N1 influenza) are a major potential threat to global health • Cases may be spread across national borders • We have to be ready in advance to conduct high-quality observational research www.prognosis.org/isaric

  3. Objectives • Facilitate local research • Make it as easy as possible for local investigators to set up and run independent observational studies • Support research in low- and middle-income countries • Coordinated observational research • Local investigator-led studies from different parts of the world can ultimately be combined to gain more powerful insights into emerging infection • Be ready before the outbreak www.prognosis.org/isaric

  4. Case report forms • Minimal case report form • Supplementary data forms • Intensive data collection forms for first 50 cases worldwide • Serial data collection where possible • Foundation for biological sampling studies www.prognosis.org/isaric

  5. Biological sampling study criteria • Urgency • How urgent is the clinical question? • Local cost • How difficult is it to recruit a patient? • Requirement for global collaboration • Could a regional/national network do this? • Peacetimerole • Is this a valid question for a common infection now? www.prognosis.org/isaric

  6. Structure • TIER 0: Case report forms only • (ethical approval not required in most jurisdictions) • TIER 1: One set of biological samples per patient • TIER 2: Serial biological samples • TIER 3: Labour-intensive studies STRATIFICATION ACCORDING TO LOCAL RESOURCE REQUIREMENT www.prognosis.org/isaric

  7. Modular protocol

  8. Adaptable to needs/resources

  9. Low sampling intensity low resource ORlarge number of cases sought

  10. Moderate sampling intensity

  11. High sampling intensityeg. Early in new outbreak, in high-resource setting

  12. Automatically generated protocol • Text is added/removed from protocol, information sheets, consent forms according to local needs • prognosis.org/isaric www.prognosis.org/isaric

  13. The International Severe Acute Respiratory and Emerging Infection Consortium

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