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The PHUSE Wiki is an PHUSE/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics.
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Working Groups News
Deliverables out for public comment:
The Analyses and Displays project has produced a White Paper and is currently seeking public feedback. The closing date is 24th June.
The White Paper is intended to provide recommendations on analyses and displays to sponsors who are planning analyses for safety topics of interest for Phase 2-4 clinical trials and integrated summary documents (or other documents in which analyses of safety are of interest).
Integration Strategies in Support of ISS/ISE Submissions Project has produced a White Paper and is currently seeking public feedback. The closing date is 15th June.
This paper describes data integration strategy recommendations by the PHUSE SDTM/ADaM Implementation FAQ Project to support the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE).
Data De-Identification Standards project has produced a White Paper on Data Anonymisation and Risk Assessment Automation and is currently seeking public feedback. The closing date is 5th June.
The objective of this paper is to draw a detailed dataset(s) anonymisation process map, identify 6 challenges and potential pitfalls of the process, suggest best practices and offer automation ideas and 7 examples
Real World Evidence Project are currently seeking public feedback. The closing date is 5th June.
Usage of RWE in clinical trials for regulatory submissions is an area of research interest, due to the advantages in cost, cohort sizes and ethical considerations. This paper attempts to collate all related information such as sources of RWD privacy laws & use cases, in one document, which can act as a reference point for individuals or companies who wish to design, conduct, and submit studies using RWE. We begin with a summary of the RWE landscape before diving into some examples. The paper also lists FDA’s current thinking about the topic as of the date of this publication.
Final Published Deliverables
The Recommendations for GDPR Compliancy White Paper covers the practical application of the GDPR to the collection, processing and storage of clinical study participant research data by clinical study sponsors and their outsourcing partners. Click here to download the paper.
The Best Practices for Quality Control and Validation project have produced a White Paper which details the concepts, best practices and methods for quality control and validation of analysis programming used for clinical trials. Click here to download the paper.
CDISC Webinar - June 30th 10.00-11.30 AM EST
CDISC and PHUSE partner to further the mission of each organisation, with CDISC focusing on developing global, platform-independent data standards, and PHUSE focusing on implementing CDISC standards. Join the Webinar on June 30th at 10am EST where the CDISC Primer and SDTM ADaM Implementation FAQ PHUSE projects will be presenting. Click here to register.
Data Transparency Summer Meeting
The Data Transparency team conducted a review of the Modernisation of ClinicalTrials.gov via the National Library of Medicine. The documented review can be found on the PHUSE website.
The Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure PHUSE CTT Project Blog
As the COVID-19 pandemic severely impacts many facets of human activity around the world, the pharmaceutical industry is being presented with significant challenges related to the manufacturing and shipping of existing marketed products and to treatment development activities. Regulatory authorities have released guidance documents focusing on the impacts to study start-up activities, changes to ongoing study procedures, and items considered urgent safety matters during this pandemic. This blog considers the impacts of COVID-19 on clinical study disclosure and transparency, offering guidance from industry experts on what may require immediate action, as well as consideration of future implications. To read the blog in full, click this link.
Last revision by Laurenwhite, 06/1/2020