The landscape of clinical research and genomic data governance is evolving rapidly, with two significant developments shaping the future of global health research and regulatory frameworks: the ongoing revision of the ICH E6 (R3) Good Clinical Practice (GCP) guideline and the recent release of WHO guidance on the ethical collection, access, use, and sharing of human genome data.
ICH E6(R3) Annex 2: Open for Public Consultation
The update of the ICH E6 (R3) guideline on Good Clinical Practice (GCP) is currently in its final stages and is expected to come into force during 2025. Its final release will depend on the regulatory authorities of each country involved in the ICH.
Since the first development of the guideline in 1996, there has been one major revision: ICH E6 (R2), published in 2016. This update addressed significant changes in the clinical research landscape, including the increasing complexity and costs of clinical studies, as well as the availability of electronic health data.
Now, 8 years later, the new revision, ICH E6 (R3), aims to modernise and enhance the effectiveness of international standards for the design, conduct, recording, and reporting of clinical studies involving humans. More specifically, ICH E6 (R3) seeks to provide greater flexibility to accommodate technological advancements and innovative study designs.
Additionally, the revised guideline promotes a collaborative approach to clinical studies, clarifying roles and responsibilities shared between sponsors, investigators, and regulatory authorities.
The ICH GCP Guideline is structured into Principles and 2 Annexes, which expand on these Principles with specific details for different types of clinical trials:
- Annex 1: Primarily addresses traditional clinical trials.
- Annex 2: Provides additional considerations, focusing on examples of trials that incorporate decentralised elements, pragmatic designs, and/or real-world data (RWD).
Currently, Annex 2 is open for public consultation until 25 February 2025. Stakeholders are encouraged to provide feedback on the draft guideline to identify any missed considerations or to clarify potential ambiguities in the text. Further details are available in the draft document.
World Health Organisation (WHO) Guidance on Human Genome Data Governance
Alongside the ICH E6(R3) developments, the World Health Organisation (WHO) has published a new guidance document on the governance of human genomic data. This initiative underscores the ethical, legal, and equitable management of genomic data, a cornerstone for advancing global health research and ensuring fair access to the benefits of genomics.
The WHO guidance establishes normative principles aimed at enhancing transparency, promoting equity, and safeguarding individual and collective rights. Each principle is accompanied by actionable recommendations to guide its practical implementation. The document serves as a crucial resource for researchers, policymakers, and institutions navigating the complex landscape of genomic data governance. By setting clear standards, it aims to foster responsible data sharing and maximise the potential of genomic research for global health advancement.
Moving Towards Ethical and Efficient Research Practices
Both the ICH E6(R3) revision and WHO’s genomic data governance guidance highlight the increasing need for adaptable, ethical, and effective frameworks in health research. While the ICH guidelines aim to modernise clinical trial methodologies, the WHO principles ensure that genomic data use aligns with ethical and legal standards, fostering trust and cooperation in the scientific community.
Stakeholders are encouraged to engage with these initiatives by providing feedback on the ICH E6(R3) Annex 2 public consultation before 25 February 2025 and by integrating WHO’s recommendations into genomic research practices. These efforts will contribute to shaping a research environment that is both innovative and ethically sound, ultimately improving health outcomes on a global scale.
