| 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. |
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| CSS 2022 | |
| CSS: This year's PHUSE/ FDA CSS takes place 19-21 September. To find out more, take a look at the agenda on the PHUSE website. Don't miss out, click here to register! | |
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Data Transparency Summer Event 2022 | |
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Data Transparency Summer Event: Thank you to all of our presenters and attendees for once again ensuring the Data Transparency Summer event was a great success! Couldn't attend? Not a problem! Click here to visit the PHUSE Engagement Hub where you can catch up on all previous online events. |
| Community Forum | |||||||||||||||||||
The Role of the Statistician and Statistical Programmer in Real-World Data Analysis: | The Real World Evidence project, part of the Emerging Trends and Technologies Working Group, | presents hosted the | next most recent PHUSE Community Forum | , taking which took place 6 July, 15:00 (BST)/ 10:00 (EST) | .Use of real-world data in regulatory submissions is growing. Real-world data provides unique insights which can be used for informed decision-making, resulting in faster drug approval. However, the nature of real-world data is quite different from that of clinical trial data. While the latter can be controlled at all stages, from collecting to reporting, this is not the case for real-world data. This | imposes many challenges including pre-study alignment with regulatory agencies regarding validity of the data used. How does this affect the roles and corresponding responsibilities of various cross-functional clinical team members?This meeting will start meeting began with a 30-minute presentation focused on the changes necessary | to use real-world data | followed by a forum discussion on how this affects . Its not too late to get involved! Join the discussions over on the online Disqus Forum and chat with like minded individuals on how the changes affects the role of the statistical programmer and the statistician. |
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Recently Published Deliverables |
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| If you wish to view the extensive list of all PHUSE published deliverables, click here. |
Bio-research Monitoring Data Reviewers Guide (BDRG) – The Optimizing the Use of Data Standards Working Group and the PHUSE BIMO Project Team are pleased to announce the publication of the Bio-research Monitoring Data Reviewer’s Guide (BDRG) Package. This reviewer’s guide was created to provide the industry with a consistent way and usable format for communicating information concerning the Bio-research Monitoring (BIMO) data to regulatory agency reviewers. The BDRG package includes an Introduction and Overview, Template, Completion Guidelines and three Examples. |
| Best Practices for the Submission of Data in Japan |
| – The PHUSE Japan e-Data Submission team has |
| recently published a White Paper on the electronic submission of data to the PMDA. This White Paper was part of the project's aim in |
| creating materials that will help global personnel submit electronic data to the Pharmaceuticals and Medical Devices Agency (PMDA). |
Recommendations for SEND Dataset QC Best Practices – The SEND Dataset QC Best Practices project within the Nonclinical Topics Working Group have been busy working on a new deliverable which has recently been published. The White Paper provides key insights into current QC activities performed by industry as well as best practice recommendations for QC procedures. The aim is to promote more consistent QC procedures to help regulatory reviewers be more confident the SEND data accurately represents the data in the study report. |
SDTM ADaM |
Implementation FAQ project, under the Optimizing the Use of Data Standards Working Group, has published a new response to a question they received |
The question is based on whether an |
SDTM domain that is in the SDTM IG v3.3 be used for a study that is using the SDTM IG v3.2 to map the study data. |
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| Projects Calling for Volunteers |
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| information on the PHUSE Working Groups and their projects, click here. |
AE Groupings for Safety (AEGiS) – The PHUSE Safety Analytics Working Group is launching a new cross-disciplinary project team: AE Groupings in Safety (AEGiS). This project team will develop points to consider when deciding whether to use a MedDRA-defined grouping of PTs versus creating a custom grouping and will provide recommendations on process/implementation (maintaining custom groupings, analysis planning, ADaM development, tables, and figures). Note, this project team will not be creating any custom groupings. Final deliverables may include presentations at scientific conferences, publishing a White Paper and/or publishing in a peer-reviewed journal. If you are interested in joining this new and exciting project, please email workinggroups@phuse.global. |
| Project Idea? |
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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, biologic 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. |
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| PHUSE Communications | |
Working Groups Latest Report: Q22022 | 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. | |
PHUSE Blogs | PHUSE Diversity & Inclusion Survey Neurodiversity: Join the Conversation Can Clinical Data processed with R be Used in a Regulatory Submission? |
