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Single compelling case reports • In some instances, one or two case reports can provide compelling evidence of causality, sufficient to change the product label, risk management etc. • Examples ‟ Progressive multifocal leukoencephalopathy ‟ Stevens Johnson syndrome (single case) ‟ Fatal anaphylaxis (single case) • See also: Anecdotes that provide definitive evidence. Aronson JK, Hauben M. BMJ 2006;333;1267-1269
Conclusions • Structured causality assessment methods for individual cases have been used to facilitate case processing rather than to reach definitive conclusions ‟ Naranjo algorithm proved to be generally unhelpful ‟ Events are considered `related’ or `not related’ for the purpose of case processing and regulatory reporting • Definitive decisions about causality (leading to RMP/label changes etc.) usually incorporate evidence from various sources ‟ Structured approaches e.g. Bradford Hill criteria ‟ No single `once size fits all’ approach • Individual case reports sometimes provide compelling evidence of causality
Page 1 and 2: Causality Assessment in Practice Ph
Page 3 and 4: Overview of presentation • Causal
Page 5 and 6: Instructions for investigators Typi
Page 7 and 8: Case processing Study cases
Page 9 and 10: Adding `events’ to the reporter
Page 11 and 12: Methods for the assessment of indiv
Page 13 and 14: Naranjo algorithm at Roche • Pre-
Page 16 and 17: Expressing causality in words `Prob
Page 18 and 19: Combining evidence from different s
Page 22 and 23: Final thoughts… • Communicating
Page 24 and 25: Back-up slides, additional referenc
Page 26 and 27: Guidance • CIOMS VI ‟ A CRF is
Page 28: Capturing the reporter’s assessme

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