Leveraging ICH E6 (R3) to Drive Efficiency in the Clinical Trial Process

Posted in Regulatory

During the 2024 Avoca Quality Consortium Summit, an ICH E6 (R3) quality panel discussion led by Karen Harvey, Senior Director of the AQC, delved into how the ICH E6 (R3) guidelines will impact clinical trial execution.

Key topics included the need for comprehensive early planning, adopting flexible and fit-for-purpose trial designs, and the crucial role of early collaboration across all stakeholders in clinical trials. The panel also emphasized the importance of leveraging new technologies like AI for data analysis, adapting to continuous shifts towards risk-based monitoring approaches, and ensuring trials are centered around participant needs.

The key takeaway from the conversation is the importance of slowing down for thorough planning and stakeholder engagement to enable faster, more efficient, and high-quality clinical trial execution under the new ICH E6 (R3) guidelines.

 Actionable steps for stakeholders include:

  1. Emphasizing Critical Data and Processes:
    Identifying the critical to quality (CTQ) factors early can help drive key study activities such as monitoring strategy.
  2. Early and Continuous Risk Assessments:
    Risk assessment focused on critical data and processes and shared across all stakeholders – including sites.
  3. Preparing Sites for ICH E6 (R3) Changes:
    Sponsors and CROs should be prepared to assist sites in understanding and adapting to the new guidelines.
  4. Promoting Cross-Industry Collaboration:
    Encouraging inclusive collaboration that integrates all perspectives for a more comprehensive approach to trial planning and execution.
  5. Adopting Flexibility and Innovation:
    Openness to integrating new technologies and methodologies, ensuring they align with maintaining quality and compliance.

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