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 Standards Implementation Governance Survey

The Best Practices in Data Standards Implementation Governance project has put together a survey to gather an insight into how organisations are currently governing data standards, including what level of governance exists, the scope of standards governed, how governance is organised, and what are the particular challenges and pain points organisations are experiencing when implementing and governing the standards. We seek responses from anyone who is involved in data standards governance or is a user of data standards, from any functional role. The data from the survey will be used to make recommendations on best practices for data standards governance implementation and to develop further projects for particular areas which are found to be the most challenging.

The closing date for this survey is 15 March. 

The Analyses & Displays for Laboratory Data team have been collaborating on a White Paper which provides updated recommendations for tables, figures, and listings (TFLs) used to analyse and display laboratory measurement with a focus on Phase 2-4 clinical trials and integrated summary documents. The White Paper is intended to provide advice to sponsors who are developing the analysis plan for Phase 2-4 clinical trials and integrated summary documents, or other documents in which analysis of laboratory measurements are of interest. Although the focus of this White Paper is on study level Phase 2-4 clinical trials and integrated analysis for regulatory submissions, some of the content may apply to Phase 1 studies, ongoing aggregate safety evaluations, or other types of medical research such as observational studies.   

The team are calling for public feedback on the White Paper, please submit feedback to workinggroups@phuse.global by 11 March.