PHUSE Working Groups provide an open, transparent and collaborative forum in a non-competitive environment in which regulators, life science companies, technology providers, SDOs, and academia can address unmet computational science needs impacting product development and regulatory review as to improve human health.
With over 50 active projects, there is plenty of opportunity to collaborate with your peers, share your knowledge and skills, and engage in discussions that will help support our regulatory agencies and partners in data submissions.
Highlighted below are some of the current projects that would very much welcome the opportunity for collaboration. If you see something of interest, please email email@example.com
Here is a link to our deliverables that are currently referenced by regulatory authorities. New members are welcome.
|Analysis & Displays White Papers
||This project includes the development of white papers that provide recommended Tables, Figures, and Listings for clinical trial study reports and submission documents. The intent is to begin the process of developing industry standards with respect to analysis and reporting for measurements that are common across clinical trials and across therapeutic areas. Script developers could then create scripts consistent with the recommendations for all to use, improving efficiency and safety signal detection. White Papers to be completed: Labs, Hepatotoxicity, Safety Topics of Interest, Vitals, Listings, ECG's, Interactive Displays for Clinical Safety Data, Treatment Emergent, Questionnaires, General Outputs Tips & Considerations.
|Code Sharing (Repository)
||This project aims to establish and maintain a collaboration platform for leveraging crowdsourcing to improve the content and implementation of analyses for medical research and for leading to better data interpretations and increased efficiency in the clinical drug development and review process. Deliverables working on: Web Application Framework for Shared Scripts, Script Metadata Use Case for SAS, Common Library Framework for Statistical Analysis, Analysis & Presentations to Monitor PV Compliance, R Initiative for Standard Analysis Scripts, Julia Initiative for Standard Analysis Scripts, Guideline for Managing Repositories, Repository Governance and Infrastructure.
|Data Reviewers Guide in XML
||This project delivered an initial prototype package in 2018, which was based on the PHUSE cSDRG package V1.2. The team is currently further refining the package based on continued public feedback and two sponsor-donated cSDRGs. An updated package is due imminently. The end goal is to have machine-readable versions of cSDRG, nSDRG and ADRG. A related project identified as SDSP-XML is also planned.
|Integrated SDTM/ADaM Reviewers Guide
||The cSDRG and ADRG apply to a single study. Sponsors have used these templates when creating reviewer’s guides for integrated SDTM and for integrated ADaM data. The template has to be changed in order to document the information for multiple studies. There is an opportunity to create a template for integrated SDTM and integrated ADaM. The project team will determine if this can be accomplished in one reviewer’s guide or if there should be two separate reviewer’s guides.
Template, Guidelines, and Example Documents
|Open Source Technologies in Clinical Research
||This project will investigate the methods an organization can use to ensure the thoughtful use of these tools within regulatory environments. These methods will include the proper installation and deployment of open-source languages, validation of frameworks and packages used in development and analysis, quality control of in-house software development, and assurance of GxP compliance. Topics will be discussed at a higher level, veering the basic concepts behind techniques for installation deployment, and validation, as well as the specifics of how these things can be put into practice. The project will walk through proper installation of the choice of development environment, and the implications of those choices. The risks of misunderstanding what these tools can do, given the environment they have been implemented, can be subtle and result in unexpected failures of applications, therefore proper validation is essential within a regulated space.
||Community Priority Pulse Survey & Paper at US Connect 2020