We realise evidence is key for developing therapeutics to overcome the current worldwide health crisis
We know clinical trials are essential for developing innovative medicines
We contribute to speed up the investigation regarding COVID-19 therapeutics
We focus on providing sponsors a harmonised and accelerated assessment of multi-national clinical trials
We are CT Cure
Who we are
CT Cure Joint Action brings together 15 Member States responsible for Clinical Trials evaluation in Europe with a common, specific and strategic role: provide a harmonised and accelerated assessment of multi-national clinical trials with COVID 19 therapeutics using the Clinical Trial Information System (CTIS) during a project period of 24 months.
COVID-19 is one of the first pandemics in history that humans have been able to fight against. Therapeutics together with vaccines have been key tools to achieve this. They help to save lives, speed up recovery time and help to avoid or reduce periods of hospitalisation.
Nowadays, in Europe the situation is better, but the situation is far from being over. Medicines continue to play a critical role in the response to the COVID-19 pandemic in a global level.
In this situation, CT Cure joint action will implement the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and supports innovation regarding such products.
A more efficient approach is paramount for the European Union’s attractiveness to run large, multinational trials.
In addition, this joint action will support other very important objectives to overcome this pandemic in the best, the fairest and the fastest way:
Motivate sponsors to seek for previous scientific advice.
Encourage participation in the horizon scanning for detecting pro-actively promising therapeutic candidates.
Allow all European citizens to get a better treatment during the pandemic.
Contribute to the creation of a favorable environment for innovation, research and development for medicines.
Encourage sponsors to seek scientific advice before submitting a trial application
Participate in horison scanning for identifying pro-actively promising therapeutic candidates
Make it possible for all European citizens to get a better treatment during the pandemic
Contribute to the creation of a favorable environment for innovation, research and development for medicines in Europe
How do we work?
CT Cure works with 6 working groups dedicated to specific roles and working coordinated as a crossfunctional team.
How can we help
Our main goal is very specific:
Provide a harmonised and accelerated assessment of multinational clinical trial applications investigating the efficacy and safety of novel COVID 19 therapeutics submitted to the Clinical Trials Information System (CTIS) under the Regulation (EU) No 536/2014
What is considered a novel COVID-19 therapeutic?
Investigational medicinal products (IMPs) without marketing authorisation
IMPs with marketing authorisation for a different indication than COVID-19- related indications
COVID-19 therapeutics with a marketing authorisation used with a new posology or in novel populations
What is the process?
Every minute counts. That´s why we reduce the assessment and decision time for a new trial application from 50 to 21 days. If a request for information is sent to the sponsor during assessment, the time from validation to decision is reduced from 81 to 42 days, still including the maximum time for sponsors to respond, i.e. 12 days. For maximum clarity and predictability, all CT-Cure timelines are fixed dates.
The Member States review process is divided into three phases:
- Assessment (including a possibility for the sponsor to adapt the application after a coordinated review including input from Ethics committees)
- Notification (through CTIS portal)
Who can apply?
In this Joint Action both commercial and non-commercial sponsosr can participate as long as the proposed trial fullfill the requirements:
- a novel COVID-19 therapeutic is studied
- at least two EU/EEA Member States are included
Documents and reports
In this page, we want to share everything we are working on
We want to make high-quality assessments as fast as possible, but we also want to learn in the process and share our knowledge with everyone that may be interested: Member States, sponsors, academia, healthcare professionals, media, citizens
You will be able to have access directly through here but you can also, check the European European Commission web
Suscribe to our newsletter