The European Union is composed of 27 different countries who have agreed to keep close economic ties, as well as to create a legislative ecosystem that facilitates joint or cross-border ventures. Thanks to these efforts, there are a similar number of European clinical trials per year as the United States.
In order to ensure the region remains a competitive and attractive option for multi-country clinical trials, this regulatory framework has had to evolve with the industry. Currently, the region is transitioning between two overarching dispositions. Here, we will offer some pointers on the differences between them, as well as their implications on trial registration, ethics, information management, and patient confidentiality.
At the moment, the European Union is in the middle of a major regulatory transition. The existing Clinical Trials Directive is being replaced by a new Clinical Trial Regulation. This process is being done in stages, and it is expected to be completed by 2022.
The Clinical Trials Directive 2001/20/EC was originally approved in 2001, and it entered into force among the different member states between 2003 and 2004. This Directive was created with the express purpose of establishing a unified standard for interventional clinical trials. In this way, it was hoped that all trials conducted across the EU would protect public health equally.
This Directive included:
On the 16th of June, 2014, the European Parliament approved Regulation EU No 536/2014. Eventually, this will completely replace the existing directive.
The Clinical Trials Regulation was created to improve the existing processes outlined by the Directive. It keeps a special focus on assisting the implementation of large, multi-country pharmaceutical trials. Because of this, it has a larger scope, and it introduces new processes to register new trials and to report any adverse events.
The new Regulation will rely on a unified IT portal, the Clinical Trial Information System. This will consist of a single web-based platform to submit applications to the EMA, notify relevant parties, and to communicate between national authorities, ethical committees, and sponsors. It will also include simpler tools to allow all citizens to look up any ongoing trials.
Furthermore, the Regulation will also set the ground rules to start, suspend, hold, or terminate a trial.\(^3\) Some of these new unified rules include:
Currently, clinical trials need to be registered under the EudraCT system, and then seek approval in each participating country. By establishing a single-portal, single-point and “single decision” approval process, the new Regulations will:
The new Clinical Trials Regulation is bringing about a greatest emphasis on transparency. However, the European Union also considers patient privacy to be a priority. Whenever sharing information across sites, or with regulatory agencies, European clinical trials will also need to take into account the existing General Data Protection Regulation or GDPR.
The GDPR uses a broad definition of “protected data” which includes any personally-identifiable information. It also sets extra protections for medical information, as it is considered specifically sensitive.
The GDPR was designed to implement and protect the following principles:
The Clinical Trial Information system was recently assessed by the European Commission (EC). On July 31st 2021, they granted their final approval and published it in the Official Journal of the European Union.\(^5\)
This final announcement has set the clock ticking. On January 31st 2022, exactly six months after the announcement, the CTIS will go live. This will finalize the implementation of the Clinical Trials Regulation.
Dokumeds is a CRO with extensive experience organizing multi-country clinical trials in Europe. We specialize in helping international clients to assess, implement, and conduct both interventional and non interventional studies across countries of Dokumeds operations.
Learn more about the current process for EudraCT registration, the structure of the new CTIS and the concrete implications of regional data protection legislation in our e-book: Navigating Clinical Trial Regulations in the EU.