The Community Forum creates a space for the PHUSE Community to unite and discuss industry topics of interest in an informal setting. Events are free and take place virtually. Recordings become available shortly after the meeting and each Working Group will use Disqus to host offline discussions and continue sharing information. Catch up on previous Community Forums below. |
Data Transparency: Data Privacy and Data Sharing in Clinical Trials – 21 February 2023 | |
Designing Your RWD Study: Is Your Data Fit for Purpose? – 6 July 2023 This was our third Community Forum of the year and included three insightful presentations from Jonathan, Elizabeth and Andy. Jonathan kicked off the Forum with a broad overview of study design considerations when using real-world data in regulatory submissions. His gentle introduction to some of the biases common to studies using real-world data prompted interesting questions on how to handle these biases and how to evaluate databases for such biases. Elizabeth’s presentation followed and got more specific, with a dive into externally controlled study designs. She guided the attendees through the industry’s experience with these study designs so far, particularly in terms of getting regulatory approval, to see what we could learn in terms of getting data that is fit for purpose. Last but not least, we got more technical, with Andy’s presentation on the FHIR[1] standard, where he talked about how FHIR may be used as part of an ETL[2] procedure to replace the manual EDC[3] from EHRs[4] traditionally done in clinical trials – an exciting idea that is very applicable to RWD and surely worth a second viewing or two! Catch up by viewing the recording and slides. Have a question for the presenters? Submit it to the online Disqus forum. | |
TheSafety Analytics Working Group presented on the various efforts related to interactive safety reviews. This was followed by a great discussion on the end goal, potential impact on , and different models for creating and sharing interactive safety review tools. Head over to the Disqus Forum to share your thoughts and ask the presenters your questions! | |
Data Transparency: Data Privacy and Data Sharing in Clinical Trials – 21 February 2023 Data Transparency Working Group lead, Devaki Thavarajah, was the host of the Working Group’s first Community Forum. The Educate the General Population project have recently published two out of a series of six videos on Data Sharing in Clinical Trials and are calling for your feedback! View the recording before submitting your feedback comments to either the Disqus forum or email workinggroups@phuse.global. | |
Safety Analytics: Reimagining a Safety Submission – Aggregate Safety Assessment Planning – 16 February 2023 | |
Emerging Trends & Technologies: Submitting Real-world Data – 18 January 2023 | |
Emerging Trends & Technologies: Ingestion and Standardization of Real-world Data – 5 October 2022 | |
Emerging Trends & Technologies: The Role of the Statistician and Statistical Programmer in Real-World Data Analysis – 6 July 2022 | |
Emerging Trends & Technologies: Enterprise Knowledge Graph supporting Business Improvement – Example with the Clinical Study Process – 29 June 2021 | |
Data Visualisation & Open Source Technology: Pharma Focused Initiatives within the R Consortium – 7 December 2021 |