Hot Topics

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.

Submitting Real-world Data – After the success of their last two events, the Emerging Trends & Technologies Working Group is back to kickstart the new year with yet another PHUSE Community Forum! Submitting Real-world Data takes place 18 January. Presenters, Parag Shiralkar and Jeff Abolafia, will present an overview of current regulatory guidance and their interpretations. Informative presentations will be alternated with Q&A sessions, followed by an online Disqus forum to continue the conversation on this subject and exchange experiences and ideas post event.
Register here and get 2023 off to a great start with a free, PHUSE virtual event! 

Reimagining a Safety Submission – Aggregate Safety Assessment Planning – The Safety Analytics Working Group will present their first ever Community Forum on 16 February 2023! Hear from PHUSE Safety Analytics Working Group Leads, Mary Nilsson and Greg Ball, as well as Barbara Hendrickson and Robert Gordon, as they introduce two new FDA premarket safety analytics documents. A discussion will then take place on how past and current efforts from cross-industry Working Groups can be leveraged to prepare the ecosystem for operationalising them. Click here to register! 

The SDTM ADaM Implementation FAQ project is currently calling for industry questions. The purpose of this project is to collect FAQ's and develop and review a response in order to provide implementation/strategy information, sometimes collaborating with FDA and CDISC. The Q&A is then published on the PHUSE Advance Hub under one of the following categories: 

• Data Submissions 
• SDTM/ADaM Nuances 
• Trial, Design, Domain 
• Validation and Conformance Rules 

If you would like to submit a question to the SDTM FAQ team, please contact workinggroups@phuse.global. 

Visit the PHUSE website to view the extensive list of all published deliverables.

The SDTM ADaM Implementation FAQ project, part of the Optimizing the Use of Data Standards Working Group, have recently published their latest response to a question they received under SDTM/ADaM IG Nuances. The question is based on Historical Data Consideration in the SV Domain (under SDTMIG v3.4).  

The Educate the General Population project, part of the Data Transparency Working Group, aim to create engaging content that can be understood and used by the general population (any member of the public regardless of their sector or profession). The team have recently published two, out of a series of six, videos on data privacy and data sharing. The purpose of these videos is to answer frequently asked questions which will enable viewers to become more informed, thus helping to have a positive impact on their families and the wider community. The two videos are an Introduction and Importance of Clinical Trials. Please submit any feedback, to workinggroups@phuse.global. 

If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global. 

The Nonclinical Topics Working Group is on the lookout for members to join the Conformance with the Tumor.xpt Specification project. The aim of this project is to create a non-exhaustive first set of technical conformance rules with the tumor.xpt specification. This project will provide the first set of validator rules to be implemented by tools already used by the industry for verification of SEND datasets, thus removing part of the current manual burden of reviewing this file.

Management of ODS Regulatory Referenced Deliverables: Do you have experience in creating any of the four regulatory referenced deliverables (cSDRG, ADRG, BDRG, SDSP)? The Optimizing the Use of Data Standards Working Group is looking for you to be a part of a new project to ensure these deliverables are kept up-to-date with regulatory guidance's. You will work with the ODS Working Group leads to coordinate updates as needed. To apply for this project, click here to submit an application form.

An exciting opportunity has arisen within the PHUSE Nonclinical Scripts project to collaborate with BioClelerate, the FDA and CDER for assistance with implementing the sendigR open-source package at your company. Collaborative team meetings will take place Fridays 8-9am EDT. Ideally, volunteers will have some programming experience (ie, python, unix/R) and some knowledge of internal SEND data storage. Click here for more information on the sendigR package and the benefits of working collaboratively. 

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, biologic and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements: 

• The projects must address significant research issues relevant to Computational Science
• The project must not attempt to address FDA policy issues
• There must be at least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here to submit. 

Working Groups Latest Report Q3/4 2022: The report includes project updates, recent and upcoming deliverables and the future plans for each Working Group.

Monthly Mailings: Our monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE.