Clinical Research and GCP Update

Why change ICH GCP E6 guideline again?

• ICH E6(R2) was finalized in November 2016.

Already at that time it was recognised that the guideline was due for a larger revision.

• This led to the 2017 reflection paper describing the renovation of the efficacy (E) guidelines − ICH E8 (on the general consideration for clinical trials; focusing on the clinical trial design principles) − ICH E6 (on good clinical practice, focusing on the clinical trial conduct principles).

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Why change ICH GCP E6 guideline again?

• Since then clinical trials have continued to evolve with new designs and technological innovations. • There is a desire that E6(R3) should be developed to provide guidance − that is applicable to different clinical trial designs − to focus on key principles and objectives. • E6(R2) included a focus on a proportionate, risk-based approach to the design and conduct of clinical trials. • E6(R3) will be designed to further advance this concept and to encourage relevant parties to utilize this approach. One size fits all approach is not suitable for different types of trials

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