Abstract:
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ECA based innovative clinical study designs can be valuable in accelerating all phases of Oncology drug development. Significant organizational investment would be required towards building up the ECA capability needed for a seamless execution of an ECA based design. These ECA capabilities encompass data strategy, data science, technology, and statistical methodology. This, in turn requires strong cross functional collaboration among statistics, clinical, programming, epidemiology, data science and regulatory groups.
This presentation will review some of the key opportunities and challenges in this regard through a case study in non-small cell lung cancer (NSCLC). We will share some recent GSK experiences with external data acquisition, cross-linking, harmonization, and statistical analysis of an ECA/hybrid ECA based study.
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