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, email: workinggroups@phuse.global.

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. 

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. 

The PHUSE Clinical Integrated Study Data Reviewers Guide project has prepared a final draft version of the iADRG. The guide provides regulatory reviewers with additional context for integrated analysis datasets received as part of a regulatory submission. The iADRG is intended to describe analysis data submitted for integrated data summaries (e.g., ISS, ISE, etc.)

The team is respectfully calling for public feedback on the iADRG which includes a template, completion guidelines and examples. Please submit any feedback by 13 April to workinggroups@phuse.global by using the iADRG feedback tracker to log your comments.  

• iADRG Template 
• iADRG Completion Guidelines 
• iADRG Example 1
• iADRG Example 2 with LDPC