| Comment Record |
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Commentor |
Dr. James Nickas |
Date/Time |
2003-03-14 19:42:46 |
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Organization |
Genentech, Inc. |
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Category |
Health Professional |
| Comments for FDA General |
| Questions |
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1. General Comments
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COMMENTS ON CAUSALITY ASSESSMENTS
In clinical trials, it is common practice for sponsors to require that investigators assess for protocol defined adverse events (AEs) at all subject evaluation points during the study. Information about all AEs, whether volunteered by the subject, discovered by the investigator during questioning, or detected through physical examination, laboratory test, or other means are generally recorded on Adverse Event or Serious Adverse Event Case Report Form (CRF) pages. In addition, investigators are commonly required to record their causality assessments for individual case safety reports on applicable CRF pages. To promote consistency of causality assessments across study sites, sponsors sometimes provide causality assessment guidance in protocols. An example of such guidance follows:
Do you think the study treatment caused or contributed to the AE? (Yes or No)
Yes: If the temporal relationship of the AE to study drug administration makes a causal relationship possible AND other drugs, therapeutic interventions, or underlying conditions do not provide a sufficient explanation for the observed event.
No: If the temporal relationship of the AE to study drug administration makes a causal relationship unlikely OR other drugs, therapeutic interventions, or underlying conditions provide a sufficient explanation for the observed event.
It would be helpful if the Agency in collaboration with safety specialists developed standard guidance for causality assessments to be applied in clinical trials for expedited reporting purposes.
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