EMA portal will make EU more attractive for drug research says EUCROF
Organisation president Stefano Marini made the prediction this week, citing the portal - which is being developed by the EMA under article 80 of the Clinical Trial Regulation - as an example of an initiative that will accelerate the trial application process.
“We strongly support the new European CTR and our EUCROF experts are actively participating in EMA meetings to contribute to the design and now the testing of the new Portal of Clinical Trials, which will support the applications of all new trials in Europe, starting in 2018.
“All our members are acting also at a local level to encourage national stakeholder to be ready for the implementation of the CTR. The expected outcome is a significant reduction of the time required to start a clinical trial in Europe.”
Clinical trial portal
According to the EMA the EU clinical trials portal - and database it is also developing - will provide a single submission and maintenance point for clinical trial applications and authorisations, covering ethics committee review, regulatory authority review and public registration of the trial, for single and multi-Member State clinical trials.
Spokeswoman Rebecca Harding told us the portal will “bring increased efficiency in the process of submission, assessment and authorisation of clinical trials” adding that, in combination with the database, it will be a source of information on all clinical trials in the EU.
She added that: "The timeframe for the development of the clinical trial database and portal foresees availability of the system for independent audit by August 2017. If the system gets a green light from the auditors, the EU Clinical Trial Regulation will come into effect by October 2018 at the latest."
Competition
The number of clinical trials conducted in Europe has fallen 25% in the past six years according to research by EUCROF.
In addition to slower trial approval processes in the EU, Marini attributed the decline to lower costs and the greater availability of study participants in emerging hubs in Asia and South America.
“These areas [Asia and South America] have the advantage of having a larger population of patients who are naïve to other treatments, making them the ideal candidates for inclusion in trials.
“Paradoxically the advanced health system and prevention in EU reduces the number of non-treated patients, particularly in advanced stages of disease. In addition the costs of trials in these regions are very competitive as compared to Europe.”
