PHUSE EU CONNECT 2023
Standardisation in a fast growing environment; MDR, EDC and other abbreviations
by Louella Schoemacher
With a fast growing portfolio, the importance and need for standardisation increases. In order to keep up with the growing number of compounds, indications and studies the argenx Data Standards team implemented a metadata repository in 2021. By having a single source of truth for our metadata we aim to spend less time and resources during study set-up phase.
Standardisation however is a dynamic process. New vendors, new guidances and new insights are all in place to improve our processes and data quality, but can be a challenge in standardisation. How many versions do we need and how to best govern different versions? When is something study-specific and when do we decide to standardise? Subsequently, how can we use the metadata repository to further expand standardisation across other processes? What is the impact on upstream and downstream processes?
With standardising our CRFs and Define-XML files we aim to have more standardised raw data. This should enable us to ease the process of creating SDTM datasets. What other actions could we undertake to reduce the time and effort to manage and clean data and to focus on analysing the data not only within, but also across trials, to focus on the bigger picture.
Last year we presented our implementation findings. Now we aim to give a short recap, but to also guide through our current activities, learnings and other projects we are focusing on to standardise more of our processes.
The journey of preparing an ISS
by Lieke Gijsbers
Setup of ADAE and ADTTE for Exposure-Adjusted Incidence Rate Reporting
by Mitchikou Tseng
Adverse events (AEs) reporting in Integrated Summary of Safety (ISS) can be a bit tricky when aggregation of AEs under the same treatment is not deemed suitable by the regulatory agency. Since we need to report AEs of two or more studies individually, analyzing the exposure-adjusted incidence rate (EAIR) is deemed more appropriate as compared to the usual crude rate analysis since it considers the different drug exposure duration of the subjects. The adverse events analysis dataset (ADAE) can be used directly to report results in your table utilizing a macro, or a time to event analysis dataset (ADTTE) can be additionally created to facilitate easy reporting of the EAIR. This paper will talk about how to setup ADAE and ADTTE to support the EAIR analysis and why this approach is more efficient, in my opinion, as compared to deriving EAIR directly at table level.
Bookmarking your aCRF without the manual effort
by Ramon Jakobs
Ensuring that a Define-XML is submission ready
by Lyanne den Braven