ICH E6(R3): advancing ethical and data-driven clinical trials

What is ICH E6 and why it matters

The International Council for Harmonisation (ICH) develops global standards to ensure the safety, quality, and efficacy of pharmaceuticals.
Its E6 Good Clinical Practice (GCP) guideline, first released in 1996, remains the cornerstone for ethical and scientifically sound clinical trials.
Now entering public consultation, revision 3 (R3) reflects the increasing complexity of research, digitalization, and new data sources such as electronic health records and wearables.

BC Platforms participated in an EMA-led multi-stakeholder workshop to gather insights from patients, clinicians, and researchers on how these updates will reshape trial design and execution.

Five core principles of Good Clinical Practice

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   Protection of participants – safeguarding rights, safety, and well-being, with informed consent and freedom to withdraw.

   
   
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   Scientific soundness – ensuring robust trial design, justified methods, and adherence to protocol.

   
   
3. 
   

   Ethical conduct and monitoring – accurate recording, analysis, and oversight aligned with GCP and local regulations.

   
   
4. 
   

   Independent ethics committee – reviewing and approving trial protocols, and empowered to halt unethical studies.

   
   
5. 
   

   Confidentiality – protecting personal data through restricted access and strong security measures.

   
   

What’s new in ICH E6(R3)

The draft introduces measures to help sponsors and investigators manage modern-day research challenges:

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  Quality and risk-based management – a new section on risk assessment, data integrity, and training throughout the trial lifecycle.

  
  
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  Innovative trial designs – guidance on adaptive studies, electronic data capture, and digital tools inspired by lessons from public-health emergencies.

  
  
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  Integration of diverse data sources – recommendations for maintaining data quality when using EHRs, wearables, and real-world data (to be detailed in Annex 2).

  
  
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  International harmonization – alignment with ICH E8(R1) for global data acceptance and streamlined regulatory processes.

  
  
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  Patient diversity and inclusion – recognizing the importance of broader representation in trial populations.

  
  

Supporting customers through compliant innovation

At BC Platforms, we stay aligned with evolving regulatory guidance to help life-sciences partners prepare for practical implementation.
Our federated data and Trusted Research Environment solutions already support risk-based monitoring, data traceability, and secure use of real-world data—all consistent with ICH E6(R3).
When adopted, the revision will deliver a modern, flexible framework that empowers innovative, ethical, and inclusive clinical research.

References

• ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3) Draft version for public consultation (2023). https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf
• Final Concept Paper ICH E6(R3): Guideline for Good Clinical Practice (2019). https://database.ich.org/sites/default/files/E6-R3_FinalConceptPaper_2019_1117.pdf