Download
request for additional ctd guidance n.
Skip this Video
Loading SlideShow in 5 Seconds..
Request for Additional CTD Guidance PowerPoint Presentation
Download Presentation
Request for Additional CTD Guidance

Request for Additional CTD Guidance

282 Vues Download Presentation
Télécharger la présentation

Request for Additional CTD Guidance

- - - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript

  1. 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.

  2. 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

  3. 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

  4. Mapping Example

  5. 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