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
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
• Text is added/removed from protocol,
information sheets, consent forms according
to local needs
• prognosis.org/isaric
www.prognosis.org/isaric
The International Severe Acute Respiratory and Emerging Infection Consortium