Trials conducted in the EU need to be registered with the EudraCT database. Since 2014, a summary of results of phase 2-4 studies that ended must also be submitted within 12 months of their end to the Clinical Trials Register, irrespective of the result (and within 6 months for paediatric trials).
The new EU Clinical Trials Regulation requires the submission of summary results and clinical study reports to be made public, based on predefined disclosure rules. A new EU Portal and Database at the European Medicines Agency for publicly-accessible information should be operational by the end of 2018.
Data from clinical trials can also be obtained for products, which have been approved by the European Medicines Agency (through the centralised approval procedure) through policy 0043 on access to documents and policy 0070 on proactive publication and access to clinical trial data, which applies to products that were approved by the EMA after the beginning of 2015.
Delivering responsible transparency and data sharing is a process of continuous development, including alignment of companies’ policies to a rapidly evolving regulatory environment
To support the sharing of clinical trial data, EFPIA and its member companies published and implemented the EFPIA/PhRMA principles for responsible sharing of clinical trial data. Going beyond the legislative requirements, the principles bring new levels of access to clinical trial data.
Principles for Responsible Clinical Trial Data Sharing
You can access member companies’ commitment letters by clicking here.
Since the publication of the EFPIA/PhRMA principles for responsible sharing of clinical trial data, companies have made great progress in developing processes for clinical trial data access schemes, translating principles into practice. We are now seeing data being shared with researchers through some particularly innovative solutions and processes. You see data sharing case studies below.
Clinical trials are evolving with new approaches, technologies and designs. They remain an essential part of medical research as they aim at providing the community with the latest innovative treatments and state-of-the-art clinical practice. In the future, clinical trial data will be enhanced by the availability of real world data from patient registries, hospitals and general practitioners. Industry is working with stakeholders to develop systems to maximise the potential of big data while protecting confidentiality of patient data, to further biomedical research.
EFPIA Clinical Trial Data Portal GatewayEFPIA's gateway for available clinical trial data offers a published list of member companies’ online portals aimed at advancing responsible clinical trial data sharing. A promise to develop these portals was established as part of joint EFPIA-PhRMA commitments on clinical trials data transparency, which came into full force on 1st January 2014.