New Legislation Passed on Clinical Data Transparency

As of April 2014, the European Union passed legislation which will require clinical trial Sponsors to publish detailed summaries of clinical trial data in a database accessible to the public upon marketing authorization. CROS NT provides recommendations on how to prepare clinical data for greater transparency for the public and greater traceability for regulatory authorities.

The European Medicine Agency’s initiative on data transparency was finally passed into draft law by the European Union, meaning that clinical trial data will no longer be confidential once marketing authorization is granted and Sponsors could face strict fines for not complying. The legislation is anticipated to take effect in 2016 with the support of the EMA.

The EU states its objectives in the opening section of the legislation, “In a clinical trial the rights, safety, dignity and well-being of subjects should be protected and data generated should be reliable and robust.

Additionally, the public database will contain full clinical trial summaries – including clincial study reports.

These latest developments signal a significant step towards greater clinical trial data transparency in the European Union, and clinical trial Sponsors need to evaluate whether they are prepared for the upcoming legislation.

Centralizing biometrics means all your data is stored in a central warehouse and/or archive which avoids having to keep track of multiple repositories. Centralizing clinical data in the early phases of drug development facilitates better integration of studies across all phases with common assessment methods, uniform traceability of data as well as the centralization of study metrics and reports.

Clinical data visualization can be important for Sponsors conducting trials in Europe who need to make informed decisions and make sense of clinical data which could eventually be shared publicly. Clinical leaders can see information that is beyond the capability of the CTMS report set . In addition, it facilitates Risk Based Monitoring which vastly improves data quality and cuts monitoring costs.

As a CRO specialized in biometrics, CROS NT can help companies make regulatory submissions to the EU and USA prepare their clinical data in a reliable and traceable way, and help remove patient identifiers if necessary. Our expert biostatisticians and clinical data management teams have completed over 1,000 studies and we have provided statistical consultancy for pre- and post-marketing studies including support at meetings with regulators. We are a CDISC Gold member and we also offer integrated EDC, ePRO, IWRS, CTMS and reporting.