September Monthly News and Updates
The Standard Analyses & Code Sharing Working Group has published a General Output Tips and Considerations White Paper. The intent of the paper is to act as a guide to accompany other papers describing different types of analyses. Click here to read.
PHUSE convened a group of experts from across industry to address the particular challenges clinical data scientists may face in their work on clinical trials. This group has published a series of blogs providing timely advice, as well as a white paper investigating what clinical data scientists can expect in the short term relating to the studies impacted by the COVID-19 pandemic, and consideration of future implications. The follow-up paper, PHUSE Clinical Data Scientists Guide to Studies in COVID-19, is due to be published by 11th September.
The PHUSE Best Practices for Data Collection Instructions project team conducted a survey to evaluate the different industry approaches for collecting adverse event data and how those data are evaluated for treatment emergence. The survey was conducted in conjunction with the Analysis and Display White Papers project team. This white paper presents the findings of the survey.
Deliverables Under Review
The Industry Experiences Submitting Standardized Study Data to Regulatory Authorities project has released a white paper for public review. The paper looks into similarities and differences between the FDA and PMDA recommendations and requirements when submitting standardised CDISC data. Public comments closes 25th September.