A look at the upcoming changes to ICH E6 Good Clinical Practice Guidelines

ICH’s planned GCP revisions are aimed at enabling researchers to maximise the potential of new technologies, reduce costs and improve patient protection. 


The steps to revision.

The development of the new ICH guidelines has taken place through a consensus-driven and science-based 5-step process that involves industry members and regulators. The draft document detailing changes will first be approved by the working group, international regulators and the ICH assembly before being submitted for review to the public. Finally, the ICH will adopt the guidance and each region will implement it.


The changes are set to be developed and implemented in two stages:


Annex 1 is set to be released in autumn 2021 and will have a focus on interventional clinical trials and the best practice guiding principles in relation to the use of approved or unapproved drugs in controlled settings.


Annex 2 will be released 12-18 months later. It will focus on interventional, non-traditional clinical trials and the best practice principles relating to non-traditional clinical trial design - including novel areas that were not considered in the previous version.


While most of the original principles of the ICH E6 guidelines still stand, there are several revisions and additions that are designed to address the use of advanced technologies and cutting-edge developments in clinical trials. Here, we take a closer look at some of the most relevant changes in the draft document.


Changes covering the well-being, safety and rights of patients.

The draft changes state that when designing trials, effort must be taken to not exclude any participant populations unnecessarily. It is stressed that the scientific goal and purpose should be carefully considered while ensuring the selection process is representative of the anticipated population who are likely to use the medicinal product in future clinical practice.


The changes also put greater emphasis on how the confidentiality of participants’ information must be protected in line with the appropriate data protection regulations.


Changes to the ways in which results are obtained.


Tools that aid the management, analysis and capture of data, including digital systems, must be fit for purpose and adhere to guidelines to ensure reliable results. The changes state that the validation of data protection, systems, user management and IT security must all be addressed to this end. Drug development clinical trials are also expected to demonstrate a greater level of transparency which can be achieved by registering trials on recognised and publicly accessible databases and sharing the results of the trials publicly. There is also emphasis on how the principles relating to gathering results will apply across all forms of media that is used for the process.



In addition, the following topics will also see incremental changes as a result of this initiative:


  • Obtaining consent of participants
  • Expertise required to design and conduct trials



Our next blog post will cover how the drafted changes to ICH Good Clinical Practice will benefit clinical practitioners. If you're keen on gaining a better understanding of the principles that are currently in place, register for our ICH certified, TransCelerate-approved Good Clinical Practice course here.



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