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Thread: Reporting of exploratory endpoints

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  1. #1
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    Reporting of exploratory endpoints

    Do results of exploratory endpoints need to be reported within the same clinical study report as the primary and secondary endpoint data?

  2. #2
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    Good idea to read the ICH E3 guidance on CSR. "11.4.7 Efficacy Conclusions
    The important conclusions concerning efficacy should be concisely described, considering primary and secondary end points, pre-specified and alternative statistical approaches and results of exploratory analyses."


    There is a also very good ICH E3 Q & A document (2012) that might be useful.
    For instance a reply to this Q: Specifically, what are the options for submission of data for topics such as pharmacokinetics, pharmacodynamics, pharmacogenomics (genomic markers), gene therapy, stem cells, biomarkers, devices, Quality of Life, Assay Validation, Data Monitoring/Review Committees, Electrocardiogram, other Safety reports, images, pictures/scans, diagnostic tests for individualized therapy, and patient-reported outcomes?

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