MedDRA in clinical trials –industry perspective
MedDRA in clinical trials ? industry perspective
SFDA-ICH MedDRA Workshop, Beijing, 13-14 May 2011
Christina Winter, MD, FFPM Medical director GlaxoSmithKline R&D / ICH MedDRA Management Board
?2011 ICH
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
? 2011 ICH
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MedDRA in clinical trials ? industry perspective
Disclaimer:
? The information within this presentation is
based on the presenter's expertise and experience, and represents the views of the presenter for the purposes of a training workshop.
? 2011 ICH
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MedDRA in clinical trials ? industry perspective
Applications of MedDRA
Numerous applications including:
? Indications for treatment ? Medical history ? Adverse events, Serious adverse events ? Investigation/test results ? Procedures
? 2011 ICH
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MedDRA in clinical trials ? industry perspective
Training and standard operating procedures
? Train
o Investigators and clinical research organisations o Within company: clinical coding team, data management,
statisticians, clinical study team, pharmacovigilance o Later stages of development: staff responsible for product
labelling
? Standard operating procedures/working practices
o Align with ICH MedDRA Points to consider documents - `Term selection' and `Data retrieval and presentation'
o Align with regional regulatory requirements
? 2011 ICH
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MedDRA in clinical trials ? industry perspective
Clinical trials - data entry
? Reporter verbatim text for AEs/SAEs obtained from
case report forms (paper or electronic)
? "Synonym list" (if used) makes autoencoding of
reporter verbatim more efficient and consistent
? Autoencoder failures are manually coded ? Queries sent to reporting investigator as needed
o Ambiguous text o Clarify events: Is `severe anaemia due to wrist cutting' a
report of two events or a suicide attempt?
? 2011 ICH
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