LANDRICH GROUP
The Impact of ICH E6 (R3) on Good Clinical Practice
The International Council for Harmonization (ICH) announced the adoption of its E6(R3) guidelines last month. These changes reflect the need for modernized guidance on clinical trial conduct. The clinical research space has undergone rapid technological and procedure change in the five years since the Covid-19 pandemic began.
The ICH, which serves as a global forum for regulatory authorities and the medical industry, now provides greater clarity for globally harmonized Good Clinical Practice (GCP) with these updates. The new guidance could reshape standards for trial design, oversight and execution.
Key Implications of the Update.
1. Risk-Proportionate Quality Management. This encourages focus on areas of the trial with the greatest impact on patient safety and clinical outcomes. “Acceptable Ranges” replace “Quality Tolerance Limits (QTLs)” for flexibility in adjustments to control measures. The prior “error” framework is replaced with “harms/hazards”, emphasizing issues that threaten safety or data integrity over problems with minimal impact.
2. Technology and Innovation. The ICH formally recognizes enabling trial digitization including remote monitoring, wearable device integration, electronic consent, decentralized hybrid trials. It also encourages new tools like AI for real-time synthesis and blockchain for data transparency.
3. Quality by Design Integration. This supports the concepts of data governance and incorporating quality into the trial design proactively, including upfront identification of Critical-to-Quality Factors.
What are Potential Outcomes of ICH E6(R3)?
1. Improved Efficiency. Some industry observers expect significant reduction in monitoring costs and faster decisions through risk-based prioritization.
2. Patient Safety. Most trial sponsors in a recent survey said they expected improved patient safety through enhanced risk mitigation.
3. Innovation Advocacy. Increased guidance around use of technology, trial decentralization and flexible frameworks can support novel research such as gene therapies.
What are Potential Challenges for Clinical Organizations?
1. Transition Overhead. Many clinical sites in a recent survey anticipated increased documentation and training demands.
2. Technology Costs. Smaller clinical trial sponsors may struggle with investments into digital infrastructure.
3. Organizational Culture. The shift to proactive and risk-based quality management may require stakeholder buy-in and transformation.
4. Vendor Management - Training and transition plans may be necessary for Sponsors and Investigators to adopt their new responsibilities to oversee clinical trial vendors.
Looking for guidance on how ICH E6 (R3) impacts your organization? Let’s connect! Landrich Group has expertise and experience in helping our client optimize for Good Clinical Practice.