My top 3 points from the recent ICH E6(R3) update were:
Increased focus on quality and links to E8 and E9;
The increasing importance of technology and data; and
Quality requires change... and change is hard.
The ICH E6(R3) Executive Working Committee (EWC) recently ran two webinars to give an update on progress and to present the findings from the latest consultation. At nearly three hours long, there was a lots to take in, and included some really interesting presentations from related organizations, but for me these three key points really stood out.
The focus on quality. There’s no surprise that they re-iterated the focus on quality in trial design and conduct. But they also emphasised the links to E8 and stressed the importance of achieving quality by good design. That includes the need for organizations to modernise and prepare for the future – future medicines, future trial designs, future technologies and future data sources. They want E8 and E6 to work together in a “Quality Continuum” that sets the foundation for new study designs and conduct, technologies and data sources. They will also link E6 and E9 to include essential documents relating to processes.
There was an acknowledgement that technology can be extremely helpful in making trials more efficient, which I wholeheartedly agree with. There was also an acknowledgement that new technologies such as AI will undoubtedly have an impact on clinical trials, and the use of these should be “thoughtful”, used to address specific issues and customized to fit the purpose and design element of each trial.
To quote the EWC directly “Change management is the greatest challenge”. They really pushed the importance of “doing things differently” and not just “adding more to the status quo”. The emphasis on change and change management is most welcome. Time and again we see that it is the single biggest blocker to the successful implementation of a risk based quality management approach.
The presentations also included some interesting information on the latest consultation and feedback from stakeholders. The EWC received over 1,300 stakeholder comments and will use those to inform further work on R3. This includes: more emphasis on critical to quality factors; increased detail in areas such as data management; and greater consistency between E6 and E8. The EWC have acknowledged they have more work to do, but I think they should be applauded for the approach they’ve taken and their continuing drive for quality in our industry.
The presentations can be found at the links below. The main content is the same, with different presentations to represent the global effort.