The European Union is inching closer to putting its data transparency legislation into place for clinical trials. The European Medicines Agency (EMA) has already released an official document detailing the legislation and it’s timelines. The data transparency policy comes into effect on 1 January 2014 and Sponsors applying for centralised marketing authorisation should note that any clinical trial data submitted after 1 March 2014 is subject to this policy.
How can Sponsors prepare for the impending legislation from a technology perspective? One solution would be to centralize data storage to allow for better data traceability and immediate results. In the clinical trial environment, traceability means knowing where clinical data is located and how information is derived.
In a decentralized scenario where data is stored across multiple CROs, there are several disadvantages including a variety of EDC vendors, replying on multiple IT vendors, little or no traceability, complicated data pooling and problems with biometrics quality.
Centralizing data storage produces several advantages:
- Information in a single point of storage/database
- One audit trail data source
- Same location for study and derived data
- Traceability is possible from beginning to product submission and market authorisation
- One portal for real-time reports
- Reporting availability on devices: laptop, tablets, smartphones, etc
Centralized Storage and Data Transparency
When the EU legislation takes effect, Sponsors will need to be able to produce data for publication in an EU database. Centralizing hosting means Sponsors only have to maintain and back up one system. Therefore, it is easier to apply logical and physical security procedures to keep data confidentiality under control. When it comes time to submit data, Sponsors can easily transfer data while ensuring data privacy.
In preparing for the EU data transparency policy, centralized storage can produce additional benefits like greater efficiency and cost reduction. Review cycles can be reduced with standardization, and the value of intellectual property is enhanced by having all data in one database; indexed, traceable and transportable.
In terms of costs, Sponsors avoid paying for multiple global library set up, programming macros and validation checks.
Of course, many pharmaceutical companies are lobbying against the EU policy with the fear that data transparency will ruin intellectual property and innovation. Many are also concerned with patient privacy and whether data mining will make personal patient data more accessible. Keep following the Arithmos blog for more updates on this legislation. To learn more about centralized storage, email us at firstname.lastname@example.org.