Demand for Extra CTD Direction.


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2. The Summary Pyramid. Clinical Overview:
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Slide 1

Ask for Additional CTD Guidance Structured way to deal with incorporated clinical rundowns/investigations and individual study reports Avoid working in pointless repetition in information and examinations in the Clinical Overview, Clinical Summary, Integrated Summary of Effectiveness, and Integrated Summary of Safety Provide commentators a system for their locale particular wellbeing and adequacy surveys.

Slide 2

The Summary Pyramid Clinical Overview: " expected to give a basic investigation of the clinical information in the Common Technical Document," CTD, 2002 Clinical Summary: "planned to give a nitty gritty, truthful summarisation of the majority of the clinical data in the Common Technical Document ," CTD, 2002 Integrated Summary of Effectiveness: "ought to give an incorporated synopsis of the information exhibiting generous proof of viability for each asserted sign." ClinStat Format, 1988 Integrated Summary of Safety: "is, to some extent, essentially a summation of information from individual studies and, partially, another examination that goes past what should be possible with individual studies." ClinStat Format, 1988

Slide 3

Clinical Summary or potentially ISS Have looked at and mapped content from ISE and ISS to substance of Clinical Summary Large cover between ISE/ISS and Clinical Summary: According to organizations: According to substance mapping investigation: ISE CS ISS CS ISE CS ISS CS + dropouts

Slide 4

Mapping Example

Slide 5

Proposed Structure Either ICH or FDA need to give clarity around clinical outlines Current FDA counsel on ISS is a progression of PowerPoint presentations and is not sufficient for industry\'s needs Proposal: Clinical Overview (2.5) is the itemized basic examination and translation of the significance of adequacy and wellbeing information Clinical Summary (2.7) is the coordinated verifiable investigation and presentation of viability and security information Module Section 5.3.5.3 ISE: discretionary incorporated viability report (talks of dry runs; examinations that include hundreds/a great many pages) ISS: presentation of indicated extra coordinated security data, quiet accounts, and unique wellbeing investigations asked for by offices

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