Dr Gibril Ndow Imperial College London MRC Unit The Gambia Gambia Hepatitis Intervention Study GHIS Start July 1986 High burden of liver cancer Mostly attributable to HBV infection Most HBV infections acquired early childhood ID: 1043027
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1. Ethics of alternative clinical trial methods in LMIC research: The GHIS experienceDr. Gibril NdowImperial College London / MRC Unit The Gambia
2. Gambia Hepatitis Intervention Study (GHIS)Start: July 1986High burden of liver cancerMostly attributable to HBV infectionMost HBV infections acquired early childhood
3. Gambia Hepatitis Intervention Study (GHIS)Opportunity: New HBV vaccineSafePrevents acute HBV infectionStart: July 1986High burden of liver cancerMostly attributable to HBV infectionMost HBV infections acquired early childhood
4. Gambia Hepatitis Intervention Study (GHIS)Opportunity: New HBV vaccineSafePrevents acute HBV infectionPrimary objectiveCan infant HBV vaccination prevent liver cancerStart: July 1986High burden of liver cancerMostly attributable to HBV infectionMost HBV infections acquired early childhood
5. Gambia Hepatitis Intervention Study (GHIS)Liver cancer incidence rate per 100,000 Gambians
6. Gambia Hepatitis Intervention Study (GHIS)Liver cancer incidence rate per 100,000 GambiansVaccine availabilityCost
7. Quantify net benefit of vaccine in preventing liver cancerDetermine other benefits of vaccinePreventing chronic HBV infectionConfer lasting immunityPrevent cirrhosisEffectively introduce vaccine into EPIVaccinate all childrenGHIS: Rationale for stepped-wedge design
8. 17 vaccination teams;excellent coverageThe Gambia, 750,000 inhabitants
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10. Phase II: Protection against chronic HBV infectionPhase III: Incidence of liver cancer in cases and controls (National Cancer Registry)
11. Ethical considerationsCountry wide vaccinationIntegrated into routine EPI scheduleLogisticsCost
12. Ethical considerationsPrimary outcome measurable in 30 – 35 yearsNew vaccines12of 20
13. Ethical considerationsPrimary outcome measurable in 30 – 35 yearsNew vaccinesFeasibility of tracing HCC casesLoss to follow-upScreening for liver cancer
14. Ethical considerationsPrimary outcome measurable in 30 – 35 yearsNew vaccinesFeasibility of tracing HCC casesLoss to follow-upScreening for liver cancerImpact on policy???
15. Ethical considerationsPrimary outcome measurable in 30 – 35 yearsNew vaccinesFeasibility of tracing HCC casesLoss to follow-upScreening for liver cancerImpact on policy???Would an RCT been more ethical?Controls: all babies born year before vaccine