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Request for Additional CTD Guidance. Structured approach to integrated clinical summaries/analyses and individual study reports

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Request for Additional CTD Guidance

  • Structured approach to integrated clinical summaries/analyses and individual study reports

  • Avoid building in unnecessary redundancy in data and analyses in the Clinical Overview, Clinical Summary, Integrated Summary of Effectiveness, and Integrated Summary of Safety

  • Provide reviewers a framework for their region-specific safety and efficacy reviews.


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The Summary Pyramid

  • Clinical Overview: “intended to provide a critical analysis of the clinical data in the Common Technical Document,” CTD, 2002

  • Clinical Summary: “intended to provide a detailed, factual summarisation of all of the clinical information in the Common Technical Document,“ CTD, 2002

  • Integrated Summary of Effectiveness: “should provide an integrated summary of the data demonstrating substantial evidence of effectiveness for each claimed indication.” ClinStat Format, 1988

  • Integrated Summary of Safety: “is, in part, simply a summation of data from individual studies and, in part, a new analysis that goes beyond what can be done with individual studies.” ClinStat Format, 1988


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Clinical Summary and/or ISS

  • Have compared and mapped content from ISE and ISS to content of Clinical Summary

  • Large overlap between ISE/ISS and Clinical Summary:According to agencies:According to contentmapping analysis:

ISE

CS

ISS

CS

ISE

CS

ISS

CS+ dropouts



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Proposed Structure

  • Either ICH or FDA need to provide clarity around clinical summaries

    • Current FDA advice on ISS is a series of PowerPoint presentations and is not adequate for industry’s needs

  • Proposal:

    • Clinical Overview (2.5) is the detailed critical analysis and interpretation of the meaning of efficacy and safety data

    • Clinical Summary (2.7) is the integrated factual analysis and presentation of efficacy and safety data

    • Module Section 5.3.5.3

      • ISE: optional integrated efficacy report (discussions of dry runs; analyses that add hundreds/thousands of pages)

      • ISS: presentation of specified additional integrated safety information, patient narratives, and special safety analyses requested by agencies


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