Industry and regulatory focus on quality in clinical research are imperative to the successful design and execution of clinical trials. Regulatory guidance evolves over time, and, periodically, updates are provided. This year, our research examines the anticipated impact and preparation for the pending finalization of the draft ICH E6 (R3) guidance.

The 2024 Avoca State of the Industry Report provides understanding of current awareness and perceptions of upcoming regulatory changes among clinical trial stakeholders to help navigate the path forward.

KEY FINDING

With a much greater emphasis on utilization of risk-based and fit-for-purpose tools and approaches, improved quality is seen as a positive impact of ICH E6 (R3). Challenges are also expected, including increased site burden and greater effort required to be inspection-ready. Further, some extension of timelines is anticipated, especially where guidance is expected to have impact on start-up. There is a shared sentiment that increased investment of time at the front-end of clinical trials will ultimately yield efficiencies over time as “new norms” are established.