| 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. |
Projects Calling for Participants
Email workinggroups@phuse.global to get involved
Central Monitoring Capabilities– Members
Central Monitoring is an emerging field with an unclear scope, goals and roles. Central Monitoring, if executed appropriately, can have a positive impact on data quality, patient safety and clinical trial efficiencies. Strong Central Monitoring practices can support risk reduction and through important trend analysis and mitigation, decrease preventable errors that can have an impact on patient safety or clinical trial conclusions.
This project will work to define Central Monitoring (including differentiating from data management and other forms of data surveillance), suggest success measures and best practices to ensure a well-connected end-to-end component of quality risk management. The project will provide insight and guidance to address understanding as well as the current and future needs of holistic Central Monitoring process and capabilities. The approach the project intends to take will encourage exploration of different approaches versus recommendations as not deter sponsor innovation (e.g - points to consider).
End-to-End Open–source Collaboration Guidance– Members
The use of open-source languages continues to increase in clinical reporting. This has helped shift pan-industry collaborations to move beyond the traditional domain of collaboration on statistical packages. Within multiple companies, we are seeing a shift where individuals may, as part of their role, contribute primarily to projects in the open-source setting. Numerous collaborations exist, with several coalescing under an umbrella collaboration called the pharmaverse. However, there remains a lack of understanding within companies around the benefits and risks of open sourcing.
This project is led by two presenters from the PHUSE CSS 2021 open-source panel and continues on from discussions and points at that event. The primary aim of the project is to provide guidance, collaboration and creation of open-source projects, as well as to link out to more information. If gaps are found, they will be noted for later follow-up and potential follow-on projects.
Working Groups Calling for Leads
Email your application to chris.price@phuse.global
Data Transparency- 2 Working Group Leads
The Data Transparency Working Group is actively seeking 2 new Working Group Leads.
Since 2014, the Data Transparency Working Group has recruited over 70 active members pharmaceuticals, CROs, software and academia, as well as CDISC and data privacy experts. Data Transparency Working Group currently has 7 active projects. An overview of each project can be found here, together with expected deliverables and timelines.
PHUSE is looking for someone with a passion to make a positive impact on the industry. Someone who is committed to dedicating their time and support to ensure the success of a PHUSE Working Group. A full list of roles and responsibilities can be found here.
If you are interested in becoming a Working Group Lead, please provide a brief summary of how you feel you can contribute to driving the Working Group forward. Please submit your application to PHUSE Working Group director, Chris Price at chris.price@phuse.global by Friday 25 March.
Emerging Trends & Technologies- 2 Working Group Leads
The Emerging Trends & Technologies Working Group is actively seeking 2 new Working Group Leads.
This Working Group looks at the future direction of our industry and has been a successful indicator for new opportunities. As a future focused Working Group, this is a home for discussions and knowledge sharing across the computational science landscape. Emerging Trends & Technologies currently has 4 active projects. An overview of each project can be found here, together with expected deliverables and timelines.
PHUSE is looking for someone with a passion to make a positive impact on the industry. Someone who is committed to dedicating their time and support to ensure the success of a PHUSE Working Group. A full list of roles and responsibilities can be found here.
If you are interested in becoming a Working Group Lead, please provide a brief summary of how you feel you can contribute to driving the Working Group forward. Please submit your application to PHUSE Working Group director, Chris Price at chris.price@phuse.global by Friday 12 April.
Data Visualisation & Open Source Technology- Working Group Lead
The Data Visualisation & Open Source Technology Working Group is actively seeking an additional Working Group Lead.
The Data Visualisation & Open Source Technology Working Group aims to support address and answer pertinent questions around data visualisation and open-source technology. The combination of these two areas is natural in today’s environment, given the powerful data visualisation tools within the open-source languages available today. Data Visualisation & Open Source Technology currently has 7 active projects. An overview of each project can be found here, together with expected deliverables and timelines.
PHUSE is looking for someone with a passion to make a positive impact on the industry. Someone who is committed to dedicating their time and support to ensure the success of a PHUSE Working Group. A full list of roles and responsibilities can be found here.
If you are interested in becoming a Working Group Lead, please provide a brief summary of how you feel you can contribute to driving the Working Group forward. Please submit your application to PHUSE Working Group director, Chris Price at chris.price@phuse.global by Friday 12 April.
Data Standards Implementation Governance Survey
The Best Practices in Data Standards Implementation Governance project has put together a survey to gather an insight into how organisations are currently governing data standards, including what level of governance exists, the scope of standards governed, how governance is organised, and what are the particular challenges and pain points organisations are experiencing when implementing and governing the standards. We seek responses from anyone who is involved in data standards governance or is a user of data standards, from any functional role. The data from the survey will be used to make recommendations on best practices for data standards governance implementation and to develop further projects for particular areas which are found to be the most challenging.
The closing date for this survey is 15 March.
The Analyses & Displays for Laboratory Data team have been collaborating on a White Paper which provides updated recommendations for tables, figures, and listings (TFLs) used to analyse and display laboratory measurement with a focus on Phase 2-4 clinical trials and integrated summary documents. The White Paper is intended to provide advice to sponsors who are developing the analysis plan for Phase 2-4 clinical trials and integrated summary documents, or other documents in which analysis of laboratory measurements are of interest. Although the focus of this White Paper is on study level Phase 2-4 clinical trials and integrated analysis for regulatory submissions, some of the content may apply to Phase 1 studies, ongoing aggregate safety evaluations, or other types of medical research such as observational studies.
The team are calling for public feedback on the White Paper, please submit feedback to workinggroups@phuse.global by 11 March.
| Open Source – Regulatory Acceptance of Open-Source Submissions |
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Registration for the Open Source Open Forum is open! The Open Source Technology in Clinical Data Analysis (OSTCDA) project is hosting their fourth Open Forum: Regulatory Acceptance of Open-Source Submissions, they will be addressing the following questions:
Come and be a part of our next virtual Open Forum on 12 July at 15:00(BST) 10:00(EDT). |
The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project within the Optimizing the Use of Data Standards Working Group, has published a new white paper. A pilot was executed to test the feasibility of using Dataset-JSON as a transport format for study data submitted with regulatory applications. The goal was to demonstrate that Dataset-JSON can serve as a transport file for study data without loss of data and no significant impact to business operations. CDISC Dataset-JSON is a modern dataset format designed for data exchange. Many software applications already import and export JSON and in the longer term more significant benefits will emerge as the constraints imposed by XPT are removed. Overall, the findings were consistent across industry and the FDA supporting the use of Dataset-JSON as an alternative transport format for XPT v5. There were several key findings from the pilot and the solutions to these will be implemented in Dataset-JSON v1.1 (due end of 2024). PHUSE and CDISC will continue to collaborate with the FDA/PMDA to discuss next steps for regulatory support. FDA/CDER/CBER testing strongly suggests that analytical tools used for regulatory review are updated to take advantage of the metadata and flexibility provided by the Dataset-JSON format. The SEND Industry Feedback Surveyproject within the Nonclinical Topics Working Group, has published the 2024 SEND Survey Results. The survey was presented at the PHUSE/FDA Computational Science Symposium (CSS) 2024 and covered topics such as Manual Edits, Implementing SEND, Harmonisation and Next Steps. The Adverse Event Collection Recommendations project within the Safety Analytics Working Group, has published a new white paper The Adverse Event Collection Recommendations. This white paper provides recommendations for adverse event (AE) collection and associated instructions for Phase II to III clinical trials, building on standardisation efforts by Clinical Data Interchange Standards Consortium (CDISC) and PHUSE. The primary intent is to reduce the variation in AE collection and instructions to improve the site experience and the quality of the data. The Quality and Reusability of Real World Data project within the Real World Evidence Working Group, has published two new Blogs! The 'Understanding the Data Quality Issues in Real-World Data Through Real-World Examples', blog takes a closer look at the experiences shared within the dedicated Working Group in exploring the types of data quality hurdles encountered when using Real-World Data (RWD).The 'Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products' blog explores the use of Real-World Evidence (RWE) as a powerful tool for informing regulatory decisions and advancing medical innovation. The Educate the General Population on Data Privacy and Data Sharing project, within the Data Transparency Working Group has published video 2 of their series. The 'What Will I Receive and When Will I Receive It?’ The video covers topics such as the concept of consent to participate in a clinical trial, an overview of trial design and treatment procedures to develop a strong foundational understanding of clinical trials. To view the full series of videos created by this team, visit the PHUSE website. |
The Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials, a new project within the Risk Based Quality ManagementWorking Group, is now calling for volunteers. This project aims to to discuss and focus on a robust strategy/process and best practices for:
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 July Multiple projects within Working Groups are open to join. PHUSE welcomes new members who can apply their knowledge to bring fresh ideas and contribute to the ongoing work of PHUSE projects. For more information, click here, read the Welcome Pack or email workinggroups@phuse.global. |
Working Groups 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. |
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 |
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They run throughout the year around the last Wednesday of every month and include presentations of hot topics in the industry and PHUSE.Click here to register and view previous presentations. Our PHUSE events are different in both nature and set-up. PHUSE events started back in 2004 with the inaugural PHUSE conference in Heidelberg. Since then, PHUSE has been organising events all over the globe. With that, we strive to meet the needs of our global community to share, advance and connect. All our events are aimed at different audiences. Click the banner above to see upcoming events
to submit. |