ICH endorses new Working Groups on Clinical Trials

The ICH Steering Committee approved the establishment of four new ICH Efficacy Expert Working Groups:

• E6(R2) EWG will work on the development of an Addendum to the current E6(R1) Guideline on Good Clinical Practices

The approach is to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality.

• E11(R1) EWG will work on the development of an Addendum to the current ICH E11 Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population

This Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development.

• E17 EWG will develop a new Guideline on General Principle on Planning/Designing Multi-Regional Clinical Trials (MRCTs)

The goal is a harmonised international Guideline to promote conducting MRCT appropriately, especially focusing on scientific issues in planning/designing MRCTs. This new Guideline will complement the guidance on MRCTs provided in ICH E5(R1) Guideline and facilitate MRCT data acceptance by multiple regulatory agencies.

• E18 EWG will develop a new Guideline on Genomic Sampling Methodologies for Future Use

Although ICH E15 Guideline describes definition of sample coding, there is currently no harmonised ICH Guideline on genomic samples collection in clinical trials or other studies. Harmonisation across regions on this topic will maximise the information gathered from the studies for e.g., sample collection and analysis (including ethical considerations) and facilitate implementation of pharmacogenomics for the benefit of all stakeholders.

Source: ICH Newsroom