Published on the 19th April 2021, this document shows that the upcoming revision to ICH GCP will be a complete rewrite of the guideline. This part of the revised document will set out the overarching principles and then there will be two annexes. Annex 1 will cover traditional interventional clinical trials and Annex 2 any additional considerations for non-traditional interventional trials.
Much of the information looks pretty familiar, so in this post I simply want to highlight what I see as the key new points from the Draft Principles document. PLEASE NOTE that this is based on the draft document published at the time of writing and so the final version may be different.
- Referring to those who take part in the clinical trial as participants not subjects – this was discussed during the public meetings and has been incorporated into this draft.
- Participant Protection and Reliability of Results are still the primary concerns – not a change, but an important point!
- Quality by Design and identification of Critical to Quality factors are emphasised in line with ICH E8(R2). Critical to Quality Factors are “attributes of a trial which are fundamental to the protection of participants, the reliability and interpretability of the trial results, and the decisions made based on those trial results.”
- Participant and physician involvement are encouraged as this can improve the quality and relevance of the trial.
- Risk Based Quality Management is emphasised “Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected.” And “Risks which have an impact on the quality factors considered critical to the trial should be managed.”
- Addition to section on Informed Consent: Take in to consideration …….. “potential use of technology to inform participants and obtain informed consent.”
- Feasibility and simplicity – processes and protocols should be clear, feasible and avoid unnecessary complexity.
- Transparency – trial and results to be published on a publicly accessible and recognised database.
- Responsibility rests with the Investigator and the Sponsor – clarification that they may delegate tasks but they retain responsibility.
- Good Manufacturing Practice – risk based approaches for the supply and handling of Investigational Product.