From late 2021 onwards, universities and hospitals across Europe will have to register new drug trials on a novel clinical trial registry. Use of the new registry will be mandatory for all institutions sponsoring drug trials taking place in the European Union.
The European Medicines Agency is running a training course to help institutions to navigate the new system.
The course will take the form of a two-day webinar. The deadline for registering is Friday, 29 January 2021. Participation is free for all non-commercial trial sponsors (universities, hospitals, charities and public bodies) and for small enterprises.
(In addition, a more extensive “CTIS Master Trainers Programme” primarily aimed at commercial sponsors is currently being prepared by EMA in collaboration with the Drug Information Association as the training provider.)
Background on the new registry
The Clinical Trial Information System (CTIS) is the successor to the current European trial registry EudraCT. It will be managed by the European Medicines Agency. Its launch is planned for late 2021.
From late 2021 onwards, all new drug trials (CTIMPs) starting up in Europe will have to be registered on CTIS rather than on EudraCT. This makes it vital for institutions sponsoring clinical trials to learn in advance how to operate the system.
However, CTIS will not immediately replace EudraCT. Instead, both systems will run in parallel. Sponsors will have to continue managing their clinical trials already registered on EudraCT, including updating their status and uploading results onto EudraCT.
Fines for failing to report clinical trial results on both registries
As soon as CTIS goes live in late 2021, the EU Clinical Trial Regulation will fully come into force. At that point, the regulation will automatically become national law in all EU member states.
From late 2021 onwards, if sponsors fail to upload the results of their drug trials within 12 months of trial completion onto EudraCT (and onto CTIS, for trials launched after 2021), they will be breaking national law.
At that point, national medicines regulators in all EU member states will have a clear legal basis for imposing fines and other sanctions on sponsors that violate the law.
TranspariMED and allied groups are actively encouraging regulators to make full use of these powers as soon as the regulation fully comes into force. At least one European regulator has already started to issue fines.
Universities and hospitals need to take action now
TranspariMED strongly urges universities and hospitals that are not yet strengthening their clinical trial reporting systems to do so immediately.
Experience shows that putting the required policies, systems and processes in place typically takes several months, so institutions that fail to take action now may not be able to avoid paying fines from late 2021 onwards.
Please note that posting clinical trial results onto registries on time is not only a question of avoiding fines – it’s also the right thing to do, both ethically and scientifically.
Sponsors can review their current trial portfolios using the EU Trials Tracker, and find useful guidance for reporting results on the TranspariMED website.
Financial and contractual implications for universities and hospitals
In addition, sponsors should start preparing now to meet the new reporting requirements of CTIS.
These include the obligation to upload a separate lay summary of clinical trial results. Sponsors should include the cost of lay summary reporting (in addition to the usual registry reporting costs) in the budgets for all new drug trials starting from late 2021 onwards, and make sure that their contracts with investigators cover all new requirements.
For more details on the new reporting requirements, sponsors should contact their National Competent Authority.
TranspariMED strongly welcomes the European Medicines Agency’s efforts to provide adequate training and resources to universities and hospitals in advance of launching the new Clinical Trial Information System (CTIS).