Get ready for EU CTR implementation with Cromos Pharma
The application of the European Union (EU). Clinical Trial Regulation (Regulation (EU) No 536/2014) will bring about significant changes to the way clinical trials are conducted in the EU. In this article Cromos Pharma’s Head of Central European Operations, Zsolt Kocsis, considers some of the key changes ahead.
The implementation of the European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) will bring about significant changes to the way clinical trials are conducted in the EU. The Clinical Trials Information System (CTIS) is set to go live on the 31 January 2022 with a transition period of 3 years planned for full migration to the new system. In this article Cromos Pharma’s Head of Central European Operations, Zsolt Kocsis, considers some of the key changes ahead.
Background
The EU CTR will replace the European Clinical Trials Directive (2001/20/EC) and is intended to harmonize the registration, assessment and supervision of clinical trials across all member states via the CTIS. The CTIS, set up and maintained by the EMA, will host the EU Portal and Database for all EU clinical trials.
Scope of EU CTR
The Regulation covers interventional clinical trials with medicinal products for human use. A new category of low-intervention clinical trials with adapted requirements also falls under the Regulation. These are:
- The investigational medicinal products (IMP) are authorized;
- If the IMP is not used in accordance with the terms of the MA, that use is supported by published scientific evidence on S&E;
- Minimal additional risk or burden to the safety of the subjects compared to normal clinical practice.
Non-interventional trials and trials without medicinal products (e.g., devices, surgery) are not covered.
Key changes
- Single e-submission via an EU portal CTIS.
- Coordinated assessment and one single decision per Member State.
- Introducing a risk adapted approach by applying less stringent rules to those trials conducted with medicines which are already authorized, and which pose only minimal risk compared to normal clinical practice.
- Increasing transparency regarding clinical trials and their outcomes.
- Simplifying safety reporting requirements.
- Reinforcing supervision of clinical trials by introducing Union Controls in Member States and third countries to ensure that the Regulation is properly supervised and enforced.
- Provisions concerning clinical trials conducted outside the EU but referred to in a clinical trial application within the EU, which will have to comply with regulatory requirements that are at least equivalent to those applicable in the EU.
- Introducing the concept of co-sponsorship.
- Informed consent – new provisions for:
- Broad consent (use of data outside the protocol)
- Simplified consent for certain cluster trials
- For trials in minors and incapacitated subjects
- For trials on pregnant and breastfeeding women
- Member States to maintain measures for other vulnerable groups (e.g., persons in military service, deprived of liberty)
- Additional detail for conducting trials in the emergency setting
- Damage compensation system to be set up by the Member States.
- Designation of national contact points by Member States.
- Archiving of the Trial Master File for 25 years.
Transparency
One of the main aims of the EU CTR is to increase transparency in relation to clinical trials. The new CTIS will be public by default but subject to limited exceptions including those related to personal data and commercially sensitive data. The goal is to allow public access to information on clinical trials so that patients can more easily access trials which may be suitable for them, find out the outcomes of trials they have participated in, and understand what is known about a medicine they have been prescribed.
In addition, greater transparency is aimed at allowing sponsors to access data on clinical trial outcomes to support marketing authorization, find out if a clinical trial they are designing has already been conducted, and if any problems have occurred in similar trials. It is important to note that the regulation takes a balanced approach to the issue of transparency weighing carefully the public interest with the interests of sponsors and researchers to protect their investment.
Transition period
The CTR will come into application in January 2022 with a 3 year transition period. During the first year of this period clinical trials can be submitted under the old or new systems. In years 2-3, trials submitted under the old system will remain under that system. After that all clinical trials must be submitted under new system (January 2025).
Key takeaways
The EU CTR aims to foster greater harmonization in relation to the conduct of clinical trials through its single point of entry model. It aims to support greater Member State collaboration by allowing for one single decision per Member State concerned. The platform used, CTIS, will be maintained and updated by the EMA. A key principle underlying the Regulation is to promote greater transparency and increase public knowledge about the conduct and results of clinical trials and promote trust and confidence in the drug development process.
Cromos Pharma and EU CTR
Cromos Pharma has in-depth regulatory expertise and experience in supporting pharma and biotech sponsors to navigate regulatory complexities. Our team is ready to help in smoothing the transition to the EU CTR by advising on protocol language and necessary new processes and ensuring compliance with new requirements.
