Support For Your DSUR Prep
Anyone who has every worked in supporting a clinical trial, knows that data submissions are nothing short of challenging. As an example, for many years, various countries’ regulatory authorities had different requirements for the content and format of aggregated safety reports. As a result, approximately 4 years ago, the International Conference on Harmonisation (ICH) initiated the use of the Development Safety Usage Report (DSUR). The DSUR is intended to be a common standard for annual reporting.
A DSUR is prepared for each investigational drug and the report is to include safety data from all completed and ongoing studies for that drug. And further, if several indications are being investigated, a single DSUR that includes data from all indications is compiled for the drug.
The FDA Guidance for Industry (http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073109.pdf) lays out the recommended SAE and demography information that should be included in a DSUR, and the document suggests that the data should be presented in simple tables and listings.
But oftentimes, integrating and presenting SAE and demography information from multiple trials is anything but simple. Our industry colleagues talk with us regularly about how they struggle with the fact that their data is in diverse formats from disparate sources. Different CROs often hold data for different trials from the same program. Across (and even within) those CROs, different EDC systems are likely being used. Add legacy studies into the mix and the prospect of integrating all of the needed safety and demography data and merging it into simple tables for a DSUR suddenly becomes anything but simple. Most of our colleagues in the industry rely on programmers and technical resources to create these needed outputs. But those traditional outputs are static and not interactive to utilize easily. And worse – it’s not easy need to submit the report from year to year.
Use of a clinical data repository (CDR) can relieve much of the burden involved in DSUR preparation. A CDR enables organizations to have complete access to ALL of their collected data – aggregated, standardized and ready for analysis and visualizations.
From cross trial views down to the patient level, a CDR takes disparate data, standardizes it based on CDISC standards and makes it accessible for utilization. Legacy studies can also be easily incorporated. Custom reporting solutions allow for deep visibility and simple views of the aggregated data. And perhaps best of all, DSUR-ready visualizations can be re-produced on demand with the click of a button.
Is preparation and submission of a DSUR part of your role? Have you found ways to increase efficiencies in integrating and aggregating the data needed for the report?
Written by Raj Indupuri
Raj Indupuri is the CEO of eClincial Solutions. He has a unique blend of hands-on technical and data management experience, and he works passionately to deliver cloud-based clinical solutions that make clinical data acquisition, standardization, aggregation and analytics absolutely simple and easy.
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