The Role of Technology in the European Union’s Data Transparency Law

l_1171_ema-transparencyLast week, the European Union took a significant step in advancing the European Medicine Agency’s initiative on clinical trial data transparency. The EU approved a draft law that will require Sponsors to publish full clinical trial summaries in an EU database accessible to the public upon marketing authorization. This news comes one month after the EMA published a summary of a Risk Management Plan (RMP) for the first time for a newly authorized medicine. 

The EU draft legislation states that, “in a clinical trial the rights, safety, dignity and well-being of subjects should be protected and data generated should be reliable and robust”. ARITHMOS looks at how technology will play a greater role in the data transparency initiative.

Clinical Data Visualization will perhaps be the most important technological component for Sponsors conducting trials in Europe who need to make more informed decisions and make sense of clinical data which could eventually be shared publicly. Conducting a trial generally leads to data being spread across multiple databases including EDC, CTMS, ePRO, safety databases, etc and if a centralized biometrics approach was not employed, such databases can be spread across multiple vendors and countries.

main_image_careersData Visualization tools facilitate drill-down and click-through to multiple levels of detail, allowing for the analysis of specific subsets and sub-populations. Customizable dashboards allow the clinical team to create ad hoc reports on site performance, data quality, safety and efficacy, drug supply, patient management etc. Using data visualization tools, clinical leaders can see information that is beyond the capability of the CTMS report set.

The return on investment from the implementation of data visualization tools is the amount of time saved by being able to access and analyze data immediately and using data to identify and fix problems.

What solutions are available for clinical data visualization?

ARITHMOS can facilitate the selection of data visualization tools by offering a variety of solutions for managing clinical trial metrics – especially cloud-based solutions that are available right on your smartphone or tablet.

ARITHMOS has partnered with some of the best business intelligence and data visualization providers to allow Sponsors to benchmark studies and track progress as well as understand Key Performance Indicators. ARITHMOS can also integrate Business Intelligence tools with Data Visualization tools on your handheld device.

With regards to pharmacovigilance and safety data, real time safety data is crucial. ARITHMOS offers cloud-based data visualization solutions for clinical safety reporting from the best pharmacovigilance systems and databases.

Why should clinical trial Sponsors conducting trials in Europe be considering technology solutions?

The EU draft law on data transparency is set to go into effect in 2016 and Sponsors can face heavy fines if they do not comply. Implementing technology solutions such as centralized storage, cloud-based clinical data visualization tools and real-time clinical safety reporting tools will allow Sponsors to prepare their data not only in a transparent way, but also in a traceable way for regulatory authorities. Being able to make real-time decisions based on readily available data will save Sponsors time and inevitably cut costs.

 

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