The European Union is one step closer to approving legislation on data transparency which would require that companies provide detailed summaries of clinical trial data be published in an EU database accessible to the public. Once marketing authorization has been granted, clinical trial data will no longer be confidential, and Sponsors can face strict fines for not complying. The proposal is expected to take effect in 2016 with support of the European Medicines Agency.
Clinical data visualization can be an important component for Sponsors conducting trials in Europe who need to make more informed decisions and make sense of clinical trial data which will now be shared publicly. Arithmos shares 4 reasons why clinical data visualization is invaluable for Sponsors.
1. Access to Data in Multiple Databases and EDC
Conducting a trial generally leads to data being spread across multiple databases, including EDC, CTMS, ePRO, safety databases etc, and such databases can be spread across multiple vendors. Data visualization tools allow the ability to drill-down data and click-through multiple levels of detail, allowing for the analysis of specific subsets and sub-populations.
2. No Technology Required
Data Visualization tools today are generally cloud based, meaning costs can be kept under control since Sponsors can “rent” software per study. Reporting tools are optimized for smartphones and tablets.
3. Ad-Hoc Reporting and Dashboards
Using data visualization tools, clinical leaders can see information that is beyond the capability of the CTMS report set. Customizable dashboards allow the clinical team to create ad hoc reports on site performance, data quality, safety and efficacy, drug supply and patient management.
4. Real-Time Results
Perhaps the biggest benefit to data visualization, clinical metrics from multiple sources can be analyzed in real time. Decision makers can identify and fix underperforming sites and make crucial decisions on study progress.
Arithmos and Data Visualization: Arithmos recognizes the importance for Sponsors to have easy and immediate access to data. We can create a web portal so our customers can view study progress and have access to real time clinical and safety data reports.