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?

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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

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