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The Analyses & Displays for Hepatotoxicity project within the Safety Analytics Working Group have published a new White Paper!

This White Paper provides recommendations for displaying, summarising and analysing measures of hepatotoxicity in tables, figures and listings (TFLs). The suggested TFLs will have implications for what and how liver-related data should be collected. If the data required to populate these TFLs is not collected, then there may be insufficient information to adequately assess the potential for a drug to cause or contribute to the cause of hepatotoxicity.

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The Optimizing the Use of Data Standards Working Group has a new project FDA Requests Public Comment on CDISC Dataset-JSON Standard and is calling for volunteers!

The U.S. Food and Drug Administration (FDA) has recently published a Federal Register Notice exploring the potential adoption of CDISC Dataset-JSON v1.1 as a new exchange standard for electronic study data submissions potentially replace the SAS v5 XPORT Transport Format (XPT) in the long term.

The FDA is seeking comments on whether to accept Dataset-JSON for regulatory applications in the future, specifically regarding:

  • The risks and benefits of industry adoption of Dataset-JSON as a new exchange standard.

  • Any integration challenges with existing tools and systems.

PHUSE, given its expertise and commitment to advancing the implementation of data standards within the pharmaceutical industry, and its recent PHUSE/CDISC pilot, is launching a short-term project to collect and synthesize comments from its members on this Federal Register Notice.

Building on the PHUSE/CDISC pilot this is an opportunity to:

  • Influence the future of regulatory data submissions.

  • Share your expertise and perspectives on data standards.

  • Collaborate with fellow PHUSE members on a timely and impactful initiative.

  • Contribute to PHUSE's position on this important topic.

We are seeking volunteers to participate in this project.

The timeline for this project will be relatively short, aligning with the FDA's comment period. We anticipate the main activities to take place during May.

If you are interested in volunteering for this important project and contributing your expertise, please express your interest by completing this Working Group Project Membership Form.

The QC Workflow Optimisationis a new project within the Emerging Trends & Innovation Working Group, is calling for volunteers.The clinical study analysis and reporting QC process has not changed in decades. It is widely agreed that there is significant overhead in using double programming, and that this may need to be revisited to accelerate and optimally use programming resources. This process has not been revisited or analysed within a modern context. The purpose of this Working Group project would be to perform this analysis and report findings

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The QC process has significant impact on the adoption of Git in statistical programming, specifically in the complexity in using Git in a way that does not disrupt the QC process. This will also impact on what is perceived as acceptable level of QC for submissions by the industry, including regulators.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 29 April 2025.

The Kick-Off Meeting for this project will be held 30 April 2025 9:00 (EDT) / 13:00 (BST) / 14:00 (CEST)

Integration of Omics Data into Clinical Drug Development, a new project within the Emerging Trends & Innovation Working Group, is calling for volunteers. 

Omics data has the promise of bringing precision medicine and targeted drug discovery to life. However, its use in clinical drug development has been quite limited due to challenges that span technical, practical, ethical and regulatory domains. The team proposes an initial short-term smaller scope of the WG focused on BioCompute and its implementation. This would ensure a focused short to mid-term delivery. The scope would entail: 

  • Establishing best practices when working with BioCompute 

  • A guide for creating and validating BioCompute Objects 

  • Submission considerations for BioCompute Objects 

  • Sharing of BioCompute Objects across the industry.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 May.

The Kick-Off Meeting for this project will be held 6 May 2025 10:00 (EDT) / 15:00 (BST) / 16:00 (CEST)

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