Part 1 of this series summarized the purpose and intention for the upcoming updates to ICH E6 and ICH E8 per the ICH’s reflection paper that is currently available here and is open to stakeholder comment until March 11th. The background section first evaluates the current state of ICH E6 and explains the need for renovation:
The changing world of research is pressuring ICH to provide guidelines to address the systemic changes in research to leverage the large amounts of data from the real world i.e. electronic health records (EHRs) and patient registries, into study design and conduct that could better inform regulatory decision-making.
The proposed ICH E6 changes seek to expand and contextualize clinical research beyond market approval into addressing value and cost of therapeutic developments to incorporate the personalized and evidence based medicine trends in the healthcare sector as seen below:
Stay tuned for Part 3 in this series covering the announced updates to ICH E6 and E8. In Part 3 we evaluate the proposed structure of the upcoming changes.
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-The Clinical Pathways Team