Analysis of Safety Data .ppt

Analysis of Safety Data Is More Enough? Marc Andersen Senior Statistician Outline / Conclusion Analysis - For what purpose Different usages Approaches and issues Best practice to be developed Is more enough? Its needed Consolidation of methods Some slides will be skipped, but present in handout *: examples will be shown separately Safety Analysis - For what Annual Report (AR) Investigator’s Brochure (IB) Integrated Safety Summary (ISS, eCTD) For planning of next study (protocol rationale) Data Monitoring Commitees (DMC, DSMB) Assessing spontaneous reports Publications Annual Report (AR) and Investigators Brochure (IB) Used for different purposes: INDs: 21 CFR 312.33 /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm IRBs: ICH E6 section 8.3.19 (note wording: annual or interim) Investigator’s Brochure (IB) ICH E6 section 7 Integrated Safety Summary (ISS) M4E: The CTD - Efficacy. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), August 2001. /cder/guidance/4539E.pdf Guideline for the Format and Content of the Clinical and Statistical Sections of an Application. Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services, July 1988. /cder/guidance/statnda.pdf Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) /cder/guidance/3580fnl.pdf Common Terminology Criteria for Adverse Events v3.0 (CTCAE), Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS. /forms/CTCAEv3.pdf May claim that ISS corresponds to eCTD section 2.7.4 Tips Get the timeslines More difficult to identify that imagined (!) There is no shortcut by study and integrated output are both neede