Working Groups News
The PHUSE Working Groups, which are led by volunteers from major stakeholders, have been developing innovative solutions that address unmet computational science needs. Here, we will look to share the latest information around the PHUSE Working Groups, from workshops to white papers, project news and industry views.
Working Group Blogs
Data Synthesis Platform Available for PHUSE Members
At a PHUSE workshop in September the Data Transparency Working Group organised a half-day session on synthetic data and its applications. This was hands-on with the attendees, using R to synthesise datasets and evaluate the utility of the generated data. The response after the workshop was positive and there was strong interest in providing a broader capability to PHUSE members to learn more about data synthesis.
We are now making available a data synthesis platform, as part of the PHUSE Open Data Repository (PODR), in partnership with Replica Analytics Ltd. This is available free for non-commercial purposes and allows users to gain first-hand experience with data synthesis. Click here for more information on how to get involved.
The Computational Science Symposium 2020 Summary and Prize Winners Blog
Back in September, the virtual PHUSE/FDA Computational Science Symposium took place, celebrating its 9th year. Click here to read a summary of the successful event, which includes an overview of the sessions and the all important prize winners.
The CDISC Primer: A Collaboration with PHUSE
Volunteers from the PHUSE Community agreed to establish a PHUSE project, in collaboration with CDISC, at the PHUSE Computational Science Symposium in Silver Spring, Maryland in 2018. The team were tasked with identifying the needs (regulatory requirements, implementation options and best practices) of new CDISC implementers and providing a central starting point where newcomers could be guided towards all aspects of CDISC data standards implementation. Click here to read how to get started on exploring the standards.
Deliverables out for Public Comment
PHUSE Working Groups Projects are soliciting feedback from the broader community on a wide range of deliverables. Click here to review the documents and provide your feedback.
Final Published Deliverables
The PHUSE SDTM/ADaM Implementation FAQ project, created a sub-team to support the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE). This sub-team has produced a White Paper which addresses the frequently asked question for guidance on how to integrate study data for an ISS/ISE. Click here to read the paper.
The Safety Analytics Working Group held a Workshop at CSS based on Planning and Interpreting Safety Analyses for Integrated Summaries. Click here to view the recording.
The CDISC Implementation Primer project has put together a series of short, animated videos as well as helpful links to introduce newcomers to the suite of CDISC Standards. Click here to read the standards.
The KPIs & Metrics project has developed upon its year 1 report which developed and published a set of Statistical Programming KPIs to measure the quality and duration of standard operational tasks. The Year 2 part of the project continued this work, concentrating efforts in two major areas: revision and additions to the terminology and definitions, and revising, re-running, and reporting the industry survey. Click here to view the Year 2 report.
Since non-interventional study data do not necessarily need to be submitted to a regulatory agency, such as the FDA, there is no strict requirement for data standards.The Data Standards for Non-interventional Studies project has developed a White Paper which looks to identify the most common data standards challenges programmers experience while working on non-interventional studies and to suggest the means to deal with these challenges. Click here to read the paper.
The Optimising the Use of Data Standards – Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Project has published a White Paper. The paper aims to share submission experiences and develop best practices including submission strategy and planning, regulatory requirements, and interactions with the regulators.
PHUSE convened a group of experts from across industry to address the particular challenges Clinical Data Scientists may face in their work. This group has published a White Paper which offers perspectives from industry experts on what Clinical Data Scientists can expect in studies in COVID-19 and strategies to address some of the challenges they may encounter. This group has also published a series of blogs providing timely advice as well as an additional White Paper that considers the impacts of COVID-19 on the collection and analysis of clinical trial data.
The SDTM ADaM Implementation FAQ project has published responses to questions submitted on Data Submissions.