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.
CSS 2020 Update
The PHUSE Board and the PHUSE Office have worked tirelessly to examine and evaluate all possible options to determine the best way forward. In collaboration with the FDA, we will be postponing the CSS from June until 20th - 23rd September. It is our current working assumption that travel restrictions will be lifted by the second half of the year and the event will be able to go ahead at this later date. More information will be shared through the Working Groups and directly with the sponsors. For more information on Single Day and Connect events, visit the PHUSE website.
We'd like to take this opportunity to thank you all for your understanding and continued support.
We are pleased to announce the virtualisation of the PHUSE/FDA Data Science Innovation Challenge 2020, which will be available to all!
Given the excellent response and the enthusiasm shown, we have decided to embrace the energy and progress with a new initiative: Innovation Friday. Every Friday* there will be a short webinar to allow people to come together and discuss future digital solutions to healthcare problems.
View the latest agenda and sign up links here.
The PHUSE Investigating Endpoint Modeling project have released a White Paper which looks to provide recommendations for modeling of anti-drug antibody (ADA) data utilising the existing domains and variables available in the CDISC SEND Implementation Guide (SENDIG v3.0), and the use of custom domains and nonstandard variables adapted from the SDTMIG to be used with SENDIG v3.1. Click here to download the paper.
The Data Transparency team conducted a review of the Modernization of ClinicalTrials.gov via the National Library of Medicine. The documented review can be found on the PHUSE website.
Call for Volunteers
Study Data Validation and Submission Conformance
Do you have experience with Ontology Development and Linked Data? The Study Data Validation and Submission Conformance project replaces its predecessor "Going Translational With Linked Data (GoTWLD)", extending existing work in both clinical and preclinical areas by further developing the data models and instance data conversion. The project will include modeling FDA Technical Rejection Criteria to facilitate the submission of data to the FDA.
If you're interested in joining this project as a team member or as a co-lead contact firstname.lastname@example.org.
New: Best Practices for writing PHUSE White Papers
The PHUSE Steering Committee have produced guidelines on how to write a White Paper. Suggestions from length of the paper and writing style, to how best to keep your audience engaged are all useful tips. You can find the Best Practices here.
In line with the Best Practices for writing White Papers, you will find the White Papers template here, together with plenty of other useful information to help support you and your project.