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Thread: Reporting of exploratory endpoints

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  1. #1
    Forum Member
    Join Date
    Jan 2023

    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
    Forum Member
    Join Date
    Nov 2011
    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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