“GCP Renovation” for the Modernization of ICH E8 and Subsequent Renovation of ICH E6! Series Part 4/4

3/6/2017

Part 3 of this series summarized “Proposed Structure for a Modernized ICH E8 Guideline and a Future Renovated ICH E6 Guideline” section of the ICH’s reflection paper that is currently available here and is open to stakeholder comment until March 11th.

The ICH’s efficacy working groups (EWGs) will lead the proposed renovation work using a stagger approach for ICH E6 and ICH E8 running parallel to ICH E9 Statistical Principles for Clinical trials, below are the five steps in the ICH process for harmonization and the proposed working group timeline:

 Source: Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 by the World Health Organization (slide 7).

Source: Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 by the World Health Organization (slide 7).

Throughout the process ICH EWGs recommend a process of information sharing, consultation and interaction that includes the following:

  1. Seek outside stakeholder comment on the Concept Paper and Business plan.
  2. Hold meetings with outside stakeholders at key guideline development milestones.

In conclusion the ICH wants to renovate and modernize ICH E6 and ICH E8 to incorporate a larger scope of research to support market applications, but also policy and treatment investment using study design that will lead to high quality data and adheres to risk-based assessments and procedures in this new electronic age.

For more information, contact SAM at samsather@clinicalpathwaysresearch.com or laidy@clinicalpathwaysresearch.com.

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Thank you!

-The Clinical Pathways Team