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The ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guideline outlining Good Clinical Practice (GCP) is the foundation for how clinical trials should be conducted.

The ICH Expert Working Group has been revising the Good Clinical Practice (GCP) guideline, ICH E6 (GCP) R3.

Representing the early phase investigative community, Richmond contributed to the public consultation of this vital document revision. Our comments and proposals were submitted to both the ICH Expert Working Group and the MHRA.

We believe the revision of the ICH GCP guidance is an excellent opportunity to promote the next generation of professional, experienced, clinical trials investigators. To facilitate this, we have requested that the Expert Working Group consider three key concepts to promote experienced investigators:

     1. The investigator pool can be considered as two distinct groups; the experienced, professional investigator often operating in a specialised clinical trials unit and the occasional investigator, who participates in clinical research alongside their normal job. Whilst greater sponsor control and influence may be necessary for part-time investigators, this can be oppressive for the skilled investigator, hindering their ability to conduct multiple clinical trials and will contribute to greater burnout.

     2. Promote the expertise of the experienced investigator. The relationship between the sponsor, the investigator, the regulator, and the patient should be collaborative as the benefits of a cooperative relationship are considerable for all parties.

     3. Promote and incentivise the next generation of professional, experienced, clinical trials investigators. In addition to retaining experienced investigators, the training of new dynamic investigators is of paramount importance. One way of engaging new investigators is relevant, flexible, and practical training and certification by professional bodies.

To view our full comments, rationale and proposal to the ICH E6 (GCP) R3 public consultation please see here.

It was essential that Early Phase Investigators are appropriately represented in this significant area of discussion. We wish to continue to work towards the best possible future for early phase research.

To find out more about this process, please email info@richmondpharmacology.com

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