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Working Groups 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.

PHUSE/FDA CSS

The 12th PHUSE/FDA Computational Science Symposium took place 18–20 September 2023. The event was a great success with 210 attendees from across industry, academia and regulatory agencies! Please visit the summary page for some more information and dates for next year and the summary video is now live to view.

Safety Analytics Webinar Series: Interdisciplinary Safety Evaluation for Learning and Decision-Making

The Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The fifth and final webinar will take place 16 November 15:00 – 16:45 (GMT) 10:00 –11:45 (EST) on the topic of 'Education for Executives', registration will open 19 October. A list of all upcoming webinars and previous webinars can be found here.

Deliverables 

The Clinical Integrated Study Data & Analysis Data Reviewer's Guide project within the Optimizing the Use of Data Standards Working Group, have just released their deliverable: Integrated Analysis Data Reviewer’s Guide (iADRG) Package. This Deliverable includes a template, completion guidelines and example documents to show that there is an opportunity to create a template for integrated Study Data and integrated Analyses Data. This deliverable will determine if this can be accomplished in one reviewer's guide or if there should be two separate reviewer's guide.

NEW SDTM ADaM Implementation FAQ question has been added to their Data Submission page, have a look to see the new and previous FAQs from the project so far.

The Centralised Monitoring Capabilities project within the Risk Based Monitoring Working Group have just published their White Paper: http://Can the Value of Centralised Monitoring Be Quantified? and the Survey Results. This White Paper dives into the results of the projects own industry survey and examines the benefits and limitations of Centralised Monitoring and other traditional monitoring strategies.


Volunteer Opportunities

Data Visualisation & Open Source Technology Working Group project, CAMIS has created a Sub-Team, CAMIS-ONCO: Comparing Analysis Method Implementations in Software, and they are now calling for Collaborators and Volunteers! Hello statisticians and programmers. Are you currently working or interested in using different software programming languages to analyse and visualise statistical results and endpoints in oncology clinical trials? Wondering how to achieve the same analysis results, e.g. hazard ratio, or confidence intervals in SAS, R and Python? We invite you to collaborate with our subgroup, CAMIS-ONCO, which is a part of the CAMIS–PHUSE Working Group, focused on comparison of statistical procedures for oncology trial analysis in different programming languages. This subgroup will further collaborate across industry to discuss open-source programming languages in analysis of results.Our group is exploring discrepancies while implementing code and documenting reasons like default options in statistical procedure statements of SAS, R and Python. We plan to further develop or extend the CAMIS GitHub code repository to analyse FDA-recommended endpoints in oncology trials with comparative results. Interested? Please check out our existing repository at https://psiaims.github.io/CAMIS/. We also invite you to be part of our white paper planning and programming for 2024: ‘Oncology clinical trial endpoint analysis in a multiprogramming world’.

The Safety Analytics Working Group's new project, Interactive Analyses and Displays for Laboratory Data is now are calling for volunteers. This project aims to bring together stakeholders from pharma, academia, and regulatory bodies with diverse backgrounds, such as statisticians, clinicians, medical experts, and programmers. The goal is to collaborate on a deliverable concerning the use of interactive displays in the assessment of laboratory data during phase 2-3 clinical trials. The deliverable will be a specification document providing platform-agnostic recommendations to stakeholders about the features and options that should be considered for interactive displays of laboratory data. This project’s scope will encompass considerations for interactive visualizations used in ongoing safety monitoring, regulatory submissions, and publications.  

Please contact workinggroups@phuse.global to register your interest in volunteering.

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. 

New Project Idea? 

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. 

PHUSE Communications 

Working Groups Report: Includes project updates, recent and upcoming deliverables and the 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 the 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 bought to you by industry professionals. 

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