The Working Group Webinars and Community Forums provide a virtual space for the PHUSE Project Leads and Community to highlight and share industry topics of interest relating to their Working Groups. These webinars 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 Working Group Webinars | |||
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Date | Title | Speakers | Recording |
5 October | Real World Evidence: Experiences with Adapting RWD to CDISC Submission Standards | Lauren Green, Amgen, Jeff Abolafia, Pinnacle 21, Christine Rossin & Pfizer, Sandra VanPelt Nguyen, Pfizer. | Recording |
6 July | Real World Evidence: Designing Your RWD Study-Is Your Data Fit for Purpose? |
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!
Andy Richardson, Zenetar, Elizabeth Merrall, Janssen Research and Development, Jonathan Assayag, Pfizer & Mary Anne Rutkowski, Merck & Co | Recording |
12 April | Emerging Trends & Technologies: RWD/RWE Programming & Reporting Standards: Utilising OMOP Standards |
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.
Berber Snoeijer, ClinLine, Mary Anne Rutkowski, Merck & Co, Jerry Wang, Janssen Research and Development & Mike Briganti, Janssen Research & Development | Recording | |
27 March | Safety Analytics: Reimagining a Safety Submission – Vision of Interactive Safety Reviews |
Greg Ball, ASAPprocess, Mary Nilsson, Eli Lilly, Wei Wang, Eli Lilly, Xiangyun Wang, Genentech, Raj Kiran, Takeda, Melvin Munsaka, Abbvie, Neetu Sangari, Pfizer, Jeremy Wildfire, Gilead, Khushboo Sharma, Accumulus & Bill Gibson, Accumulus | Recording | |
21 February | Data Transparency: Data Privacy and Data Sharing in Clinical Trials |
Devaki Thavarajah |
, Instem & Deborah Collyar, Founder and President, Patient Advocates in Research (PAIR) | Recording |
16 February | Safety Analytics: Reimagining a Safety Submission – Aggregate Safety Assessment Planning |
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.
Greg Ball, ASAPprocess, Mary Nilsson, Eli Lilly, Mac Gordon, Janssen Research & Development & Barbara Hendrickson, University of Chicago | Recording | |
18 January | Emerging Trends & Technologies: Submitting Real-world Data |
Parag Shiralkar |
, Sumptuous Data Sciences |
& Jeff Abolafia |
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.
RealWorld 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.
Data Visualisation & Open Source Technology: Pharma Focused Initiatives within the R Consortium – 7 December
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.
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.
, Pinnacle 21 | Recording |