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PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please email workinggroups@phuse.global. |
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The Open Source Technology in Clinical Data Analysis (OSTCDA) project was set up with the aim to create a manuscript on the integration of open-source software solutions for clinical data management, analysis and reporting.
A significant amount of time and energy has been invested in recent years exploring the desirability (do we want it?), feasibility (can we do it?), and viability (is it worth it?) of integrating open source solutions into our clinical data pipelines which transform source data into clinical study reports and submission data packages. In this October edition of the Open Source Open Forums, we will provide an update on the status of this initiative and continue to hear from you on what we’ve missed so far.
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When this manuscript is complete, we hope to put to rest some of the burning questions that we believe we now know the answers to. This will allow industry, and all the passionate people in it, to look ahead and start tackling the next horizon of challenges related to using open source solutions for clinical data pipelines. We hope you will contribute your expertise to this effort. The OSTCDA Project will be hosting their next forum to discuss the above, titled Open Source Technologies in Clinical Data Analysis.
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Data Transparency | ||
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The Data Transparency Autumn Event. 16–18 September at 10:00-12:30 (EDT) / 15:00-17:30 (BST) / 16:00-18.30 (CEST)
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Real World Evidence | ||
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Community Forum: Getting the RWD We Need – From Both Sponsor and Regulator Perspectives 7 October at 10:00-11:00 (EDT) / 15:00-16:00 (BST) / 16:00-17:00 (CEST)
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Data Visualisation & Open Source Technology |
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Working Group Webinar: Exploring the Synergy of Generative AI and the Teal Framework in Pharma 10 October at 10:00-11:00 (EDT) / 15:00-16:00 (BST) / |
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RWD Sources – How the Genesis of Your Data Determines What Questions You Can Answer.
When considering sources of RWD, it is important to consider more than just the number of available patients. Recently released guidance from the FDA encourages researchers to build accurate, complete and traceable real-world datasets. Combining data from structured and unstructured electronic health record data, closed claims, and other sources is essential to building the patient journey.
In our October Community Forum, we will explore two different angles of RWD sourcing from the provider’s point of view:
- Tim (Verantos) will share with us novel insights into unstructured data and examples of the value that can be leveraged from such data.
- Matt (Azimuth) will share with us details and example analyses of a unique research data source derived from linking claims and EHR data hosted by the Department of Defense network.
Come and join us for what promises to be another very interesting Community Forum!
This Forum will be taking place over Zoom on 24 October at 14:00-15:00 (BST) / 9:00-10:00 (EDT).
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The PHUSE Data Transparency Autumn Event took place from 17–19 September 2024. During this virtual event, presentations were delivered across the three days in bitesize chunks. Each day also hosted a panel discussion and Q&A session focused on the day's themes.
Visit the PHUSE archive for all previous event recordings and presentations.
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Data Transparency |
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The Good Transparency Practicesproject has published a new Guideline. Good Transparency Practice (GTP) is a guideline developed by the Data Transparency Working Group to create a set of best practices to govern the anonymisation of clinical trial data, for external sharing or disclosure. Although there are transparency initiatives across the globe, with differing guidelines, the common goal is to uphold patient privacy and data utility to the highest standards. |
Data Transparency |
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The Rare Disease/Small Population Data Sharing project within the Data Transparency Working Group has published a new White Paper. The purpose of this White Paper is to review potential barriers to the sharing of rare disease data, such as risk of re-identification and invasion of privacy (balanced against maintaining data utility), to understand if and how these barriers apply to controlled access data sharing under specific contextual assumptions. |
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Risk Based Quality Management | ||
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The Risk Based Quality Management Working Group have produced a survey on the topic of SDR/SDV in China. The goal of this survey is to gain insight into how companies across the industry are implementing SDR and SDV in sites in China. The output of the survey will be used to develop a reference document for informing future study approaches and/or adjusting current approaches to better align with global standards. The closing date for completing the survey: 20 September.
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Emerging Trends & Innovation – Calling for Feedback |
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The Cloud Adoption in the Life Sciences Industry project within the Emerging Trends & Innovation Working Group has produced a White Paper 'Cloud Services, A Framework for Adoption in the Regulated Life Sciences Industry'. This paper sets out guidance on developing effective cloud exit strategies in the regulated life sciences industry. It explores how organisations can safeguard data security and integrity, maintain business continuity, meet compliance requirements, manage risks, and prevent vendor lock-in. By planning ahead, companies can stay resilient, flexible, and prepared for both planned migrations and unexpected provider changes. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: |
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10 October |
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The Nonclinical Topics Working Group has just formed a new project titled Developing Predictive Models to Facilitate Interpretation of Toxicology Study Results which is now calling for volunteers.
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Data Transparency: Call For Volunteers |
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The PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance project is extending its work and has a new opportunity to provide feedback on the ISRCTN Results System Prototype. This new registry is designed to align with World Health Organisation (WHO) data requirements and UK clinical trial regulations, making results submission easier, more flexible, and more accurate, while ensuring access and re-use of trial results. Background Information: ICRCTN recently released information for public review and comment regarding the new registry they are working on, and the results system prototype is open for review until the end of September. The key principles of this results system is to comply with the WHO data requirements and UK clinical trial regulations, making results submission as easy as we can and provide flexibility for different study designs. Also to help researchers submit accurate and complete data, along with ease of access to this information and re-using the results. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 24 |
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September. |
Real World Evidence: Call For Volunteers |
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The Applying Advanced Data Privacy Methods to Real World Data (RWD), a new project within the |
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Real World Evidence Working Group, is now calling for volunteers. |
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The goal of this project is to develop a comprehensive, cross-disciplinary resource to support individuals and organisations in applying advanced privacy-preserving techniques to real-world data (RWD). Given the evolving landscape of privacy regulations and the increasing complexity of data sources – including integrating machine learning (ML), artificial intelligence (AI) and large language models (LLMs) into healthcare pipelines – this project will serve as a critical foundation for advancing privacy-preserving data integration frameworks for RWD. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: |
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The Risk Based Quality Management Working Group have just launched a new project titled Enhancing the Clinical Trial Risk Assessment Process which is now calling for volunteers.
This project proposes beginning this project by identifying CtQ factors via a risk assessment process (characterising risk including assessment and mitigation/risk reduction strategies), which would include identifying trial-level QTLs that support CtQ factors.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: Closing date: 1 November
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Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global.
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The Japan eData Submission Working Group project have published two surveys: Data Listings in Clinical Study Reports and Real World Data (RWD). The results will be presented at the APAC Single Day Event (SDE) in Tokyo, Japan on 6 December, which will open for registration next month.
Download the reference files for collecting feedback from your organisation. Please consolidate all responses internally and submit a single survey response per organisation.
Companies involved with PHUSE (limited to companies operating in Japan), please complete the surveys below by 11 October.
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The CDISC Standard for Exchange of Nonclinical Data (SEND) data standard has created new opportunities for collaborative development of open-source software solutions to facilitate cross-study analyses of toxicology study data.
A sub team of the BioCelerate SEND Implementation for Cross Study Analysis Initiative was formed and through collaborative efforts via a public–private partnership between BioCelerate and the FDA/Center for Drug Evaluation and Research (CDER), they worked to develop and publicise novel methods to facilitate cross-study analysis of SEND datasets.
As part of this work in collaboration with the Pharmaceutical Users Software Exchange (PHUSE), an R package called sendigR has been developed to enable users to construct a relational database from a collection of SEND datasets and then query that database to perform cross-study analyses. The sendigR package also includes an integrated Python package, xptcleaner, which can be used to harmonise the terminology used in SEND datasets by mapping to CDISC controlled terminologies. This package, sendigR, will provide data scientists and toxicologists with a free, open-source tool that can be utilised to query large repositories of electronic standardised toxicology study data. sendigR was published to the Comprehensive R Archive Network (CRAN) and GitHub - phuse-org/sendigR: Enable Cross-Study Analysis of 'CDISC' 'SEND' Datasets. An R Shiny web application was included in the R package to enable toxicologists with no coding experience to perform historical control analyses. Experienced R programmers will be able to integrate the package functions into their own custom scripts/packages and potentially contribute improvements to the functionality of sendigR.
To learn more, read the sendigR accompanying manuscript here: Frontiers | sendigR: an R package to leverage the value of CDSIC SEND datasets for cross-study analysis (frontiersin.org)
sendigR reference manual: Enable Cross-Study Analysis of CDISC SEND Datasets • sendigR (phuse-org.github.io)
sendigR R Shiny demo app: phuse-org.shinyapps.io/sendigR/-------------------------------------------
7 October. The Kick-Off Meeting for this project will be held on 8 October at 9:00-10:00 (EST) / 14:00-15:00 (BST) / 15:00-16:00 (CEST) |
Real World Evidence: Call For Co Lead |
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We’re looking for a Working Group Lead for our Real World Evidence Working Group. Working Group Scope TheReal World Evidence Working Group aims to support, address and answer pertinent questions around real-world evidence. The Working Group is dedicated to sharing across the PHUSE Community (through Community Forums) and aligning on the best industry practices. Some of the questions we intend to address are:
Current Projects
Working Group Lead Roles and Responsibilities You can learn about the role and the responsibilities here. If you are interested in this role or have any questions, workinggroups@phuse.global. Closing date: 7 October. |
If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
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Working Group Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group. | |
Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE. | |
PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. |
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Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
New projects can be submitted anytime during the year, click here to submit. |