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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. 

2023 Community Forum Events

Real World Evidence: 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.

Emerging Trends & Technologies: RWD/RWE Programming & Reporting Standards: Utilising OMOP Standards – 12 April

Real-world data is a rich source of information that we are now starting to use for regulatory submissions. However, as the collection and validation of this data is less standard and restricted than clinical trial data, it poses a lot of challenges that we, as an industry, are not used to. Working with missing data, different analysis techniques, different dictionaries and data models poses challenges for our clinical and statistical programmers.

During this Community forum, presenters dived into this and give examples of mapping and data handling in two ways (OMOP to SDTM and source/SDTM to OMOP). They explored the challenges of mapping to and from OMOP, which is a more open standard than SDTM and uses a stricter model with strict implementation guides. 

Safety Analytics: Reimagining a Safety Submission – Vision of Interactive Safety Reviews – 27 March 2023

The Safety 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
During this Community Forum, presenters introduced two new FDA premarket safety analytics documents and discussed how past and current efforts from cross-industry Working Groups can be leveraged to prepare the ecosystem for operationalising them.

Emerging Trends & Technologies: Submitting Real-world Data – 18 January 2023
Presenters Parag Shiralkar (Sumptuous Data Sciences) and Jeff Abolafia (Pinnacle 21) will discuss the approach to planning the submission of RWD to regulatory bodies. As part of the planning, interpretation and use of regulatory guidance, this Community Forum will investigate issues, gaps and challenges, as well as possible resolutions and recommendations, for submitting RWD. Catch up now by viewing the recording. Got a question for the presenters? It's not too late to post it on the Disqus forum! 

2022 Community Forum Events

Emerging Trends & Technologies: Ingestion and Standardization of Real-world Data – 5 October 2022
This Community Forum discussed the options and challenges when using and standardizing a variety of available real-world data sources including the corresponding data models and ingestion methods. Questions and discussions took place after each topic as well as a general Q&A at the end. Couldn't attend? Catch up by viewing the recording. 

Emerging Trends & Technologies: The Role of the Statistician and Statistical Programmer in Real-World Data Analysis – 6 July 2022
Real World Evidence hosted the Community Forum, The Role of the Statistician and Statistical Programmer in Real-World Data Analysis, which took place place 6 July 2022. This event started with a 30-minute presentation focused on the changes necessary to use real-world data, followed by a forum discussion on how this affects the role of the statistical programmer and the statistician.

2021 Community Forum Events

Emerging Trends & Technologies: Enterprise Knowledge Graph supporting Business Improvement – Example with the Clinical Study Process – 29 June 2021
Enterprise Knowledge Graph supporting Business Improvement – Example with the Clinical Study Process featured ex-employee at Novartis, Cedric Berger, as the presenter. Cedric lead the discussion with his experiences on how an enterprise knowledge graph enables to reconsider and significantly improve the process of designing, implementing, conducting a clinical study as well as cleaning, analysing and publishing collected data. The recording is available to view here.

Data Visualisation & Open Source Technology: Pharma Focused Initiatives within the R Consortium – 7 December 2021
The first ever PHUSE Community Forum was hosted by the Data Visualisation & Open Source Technology Working Group. Joseph Rickert of RStudio discussed ongoing initiatives within the R Consortium focused on the use of R in pharma.

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