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)
ISARIC/WHO BIOLOGICAL SAMPLING PROTOCOL Ken Baillie MD PhD, Chair, Genetics, Pathogenesis and Pharmacology Working Group, International.
Jan 05, 2016
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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
• 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
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
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
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?
• Peacetime role– Is this a valid question for a common infection
now?
www.prognosis.org/isaric
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
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Modular protocol
Adaptable to needs/resources
Low sampling intensity low resource OR
large number of cases sought
Moderate sampling intensity
High sampling intensity eg. Early in new outbreak,
in high-resource setting
Automatically generated protocol
www.prognosis.org/isaric
• Text is added/removed from protocol, information sheets, consent forms according to local needs
• prognosis.org/isaric
The International Severe Acute Respiratory and Emerging Infection Consortium
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