It can take 12 years and cost nearly $2 billion to develop a new medicine. Clinical trials provide information on the safety and efficacy of medicines and are the basis of this process, representing 58.6% of the total development cost. Regulatory authorities rightly scrutinise the authorisation, conduct and eventually the results of clinical trials.
Clinical trials allow the European research and clinical community to work with cutting-edge scientific discoveries and innovative medical care, andcan provide patients with early access to the latest medical innovations. Sometimes they are the only option to treat a condition. Trials also provide a significant contribution to the European knowledge economy, and to achieving the EU 2020 headline target that 3% of GDP is invested in R&D. Unfortunately, European clinical research has been losing ground to other regions over the past decade.
Clinical trials must be stringently regulated to ensure they are ethical, scientifically sound and conducted to high quality standards. The recently approved Clinical Trial Regulation provides this regulatory framework.
The implementation of the Clinical Trial Regulation over the next two years is a unique opportunity to demonstrate Europe’s commitment to clinical innovation, scientific collaboration and transparency of clinical trial information.
One major component for the successful delivery of the revamped regulatory system is the development of a new European IT infrastructure consisting of a Clinical Trial Portal and an associated European Clinical Trial Database. This infrastructure will be developed and hosted by the European Medicines Agency (EMA) in London and its technical readiness will determine the actual implementation date of the new Regulation.
The Portal will mainly be used by commercial and non-commercial organisations that conduct clinical trials (also called Sponsors). It will also be used by regulatory authorities as a single communication interface during the submission, assessment and decision procedures related to the clinical trial application process. It will also include a specific interface for patients and the public to view important information about all ongoing, completed and discontinued clinical trials in Europe, including laymen’s friendly summaries of clinical trial results.
The Database will function as a central European repository to store all documentation related to the authorisation and supervision of clinical trials in Europe, which can commonly be accessed by all Member States.
To support the EMA in its important work to bring this new IT infrastructure to life, EFPIA has conducted a systematic analysis of the Clinical Trial Regulation requirements for EU Clinical Trial Portal and Database. This analysis has revealed the extent of the coming change, as 60% of the future required actions are not performed by EudraCT (https://eudract.ema.europa.eu/) or the EU Clinical Trials Register (https://www.clinicaltrialsregister.eu) – the current EU IT systems.
This work has also allowed EFPIA to identify three essential elements which are crucial for success:
- Delivery of a flexible, efficient and streamlined clinical trial authorisation procedure to avoid administrative delays;
- Enabling the required collaboration between concerned Member States, as well as Sponsors;
- Appropriate management of transparency and access to data over the duration of a clinical trial.
Stakeholder collaboration is the key for success in developing the new IT system. As a major user of the future system, Industry wishes to bring to the table forward-thinking, balanced and knowledgeable suggestions.
Smart implementation of the new EU IT infrastructure is an important opportunity to demonstrate Europe’s commitment to clinical innovation, and to encourage collaboration that advances science and provides early treatment opportunities for patients. We believe that close partnership with Sponsors during the IT development phase will enhance the user friendliness of the new system from the start.
We must get this right and Industry is ready to contribute our experience in advising the development of IT systems and associated business processes!
Read EFPIA’s position paper “EFPIA Principles for the Development of the EU Clinical Trials Portal and Database“.