The benefits of the upcoming changes to ICH E6 guidelines

For clinical practitioners across all sectors, maintaining GCP compliance is always paramount. With changes to the Good Clinical Practice Framework on the horizon, it isn’t surprising that practitioners are wondering how the alterations will benefit them. Here, we take a closer look at the updates to the GCP framework and how they will make it easier for researchers to display good clinical practice in their work.



A reduced burden and removed barriers

The latest guideline changes are set to further highlight RBM (risk-based monitoring) and remove the past barriers to taking this approach. As a result, investigative sites will see their burden reduced, while enrolment and participation in trials is set to increase. It will also become easier to manage costs and speed up the regulatory approval of new drug candidates. This move will also enable more structured approaches to risk, by allowing an effective quality management strategy that embraces and leverages technology.

 

A better approach to adaptive clinical trials

An adaptive clinical trial takes advantage of the accumulation of data during the trial itself, with researchers modifying the trial’s parameters in real-time to pre-specified rules. For this reason, an adaptive trial’s data needs are significantly different than those of a traditional trial, with interim data frequently required.

 

The existing guidelines do not consider the different types of trials and analysis, and this means that heavily GCP-motivated processes currently stifle adaptive trials. The updated approach will be actively structured to guard against unintended consequences so clinical research can move precisely and rapidly.

 

Easier collection of data

Technology allows data to be collected more effectively and trials to be managed and designed more efficiently. For example, patients can now be assessed remotely to increase convenience and safety, evidence can be easily aggregated from several digital sources, and specialised AI and machine learning-driven platforms can now parse collected data to instantly discover anomalies and patterns that could not be detected unaided.

 

Technology also accelerates and streamlines every aspect of clinical development. Thanks to the change in guidelines, researchers can effectively run adaptive trials, decentralised trials, IND-exempt and biomarker trials, and multi-modality platform trials and speed up the development of essential new treatments. The guidelines will also be more flexible so that longer planning horizons can be supported alongside the shift in clinical trials.

 

RBM will have a more clarified role

Risk-based monitoring became a requirement in the industry instead of just a recommendation in 2016’s update of the ICH E6 guidelines. RBM uses advanced technologies to ensure quality by taking a comprehensive approach to safety, quality and operational risks. Yet, while the 2016 updates encourage more efficiency in archiving, reporting, and monitoring, they failed to specify how this would take place. This uncertainty has led to researchers either failing to adopt the latest methods or undertaking considerable amounts of additional paperwork.

 

The ICH E6 update that will take place later in 2021 will clarify the role of RBM in clinical trials, thus eliminating the need for unnecessary paperwork. It will also encourage the uptake of the most advanced methods, even by researchers who have been unwilling to adopt them due to the lack of clarity on risk-based monitoring up to this point.

 

Future flexibility

The ICH E6 changes that will take place in the next few months and years will certainly not be the last of their kind. Technology and science will continue advancing, and this will lead to methods being refined and improved upon. It is clear, then, that the new version of the guidelines must be built with sufficient flexibility to adapt to new technologies and designs.  

 

For practitioners, these updates will succeed by having a broader focus on objectives and principles and by further advancing the idea of risk-based approaches to trials. This will make the process of running a clinical trial more streamlined, more convenient and, ultimately, more successful. 

 

 

                                 

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