We realize evidence is key for developing therapeutics to overcome health crisis
We know clinical trials are essential for developing innovative medicines
We work in helping to speed up the review of clinical trial applications investigating new therapeutic strategies in COVID-19 allowing us to be better prepared to face future health crises
We focus on providing sponsors a harmonized and accelerated assessment of multi-national clinical trials
We are CT Cure
Who we are
COVID-19 pandemic was the first one in history when humans have been able to fight against. Therapeutics –vaccines and also treatments- were the key issue in achieving it. They helped to save lives, speed up recovery time and help to avoid or reduce periods of hospitalization.
With the aim of improving the availability, accessibility and affordability of medicines and medical devices as well as relevant products in case of health crises and supporting innovation for such products, in 2022, the EU launched the CT Cure joint action as part of the EU4Health Programme.
This project was then born with a very concrete and strategic role: to provide a harmonised and accelerated assessment of multinational clinical trial applications with COVID-19 therapeutics using the Clinical Trials Information System (CTIS) for 24 months.
Nowadays, the situation around this disease has evolved significantly and, as a result, the project has expanded its scope to therapies that bridge the gap between therapeutic and preventive treatments in order to include as many clinical trials as possible and make the European Union a more attractive region for large, multi-country trials using master protocols.
So, this joint action will also work to face possible public health crisis in the best, the fairest and the fastest way:
- Motivating sponsors to seek for previous scientific advice.
- Encouraging participation in the horizon scanning for detecting pro-actively promising therapeutic candidates.
- Allowing all European citizens to get better treatments.
- Contributing to the creation of a favorable environment for innovation, research and development for medicines.
A more efficient approach is paramount for the European Union’s attractiveness to run large, multi-country trials.
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.
How do we work?
CT Cure works with 7 working groups dedicated to specific roles and working coordinated as a cross-functional team.
Participating Member States
Fifteen Member States have confirmed their participation but besides these, other Member States, have expressed interest in joining the expedited assessment.
How can we help
Our main goal is very specific:
Provide a harmonized and accelerated assessment of multinational clinical trial applications 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 from 50 to 21 days. The process is divided in three phases:
- Validation
- Assessment (including a national assessment, a coordinated review and input from Ethics committee)
- Notification (through CTIS portal)
Who can apply?
In this joint action both commercial and non-commercial sponsors can participate as long as the proposed trial fulfil the requirements:
- it tackles COVID-19 therapeutic or therapies that bridge the gap between therapeutic and preventive treatments for COVID-19 symptoms
- at least two EU/EEA Member States are included
How can you apply?
You only have to apply through CTIS in the usual way –if you have any doubts regarding that, you can check CTIS support site– and we will thank you if you get in touch with us to avoid losing any time and start the validation right away
How to solve my doubts?
You can write an email to EU4HEALTH_CT-CURE@fagg-afmps.be, and we will reply to you as soon as possible with an answer or redirect you to those who can be more helpful
Documents and reports
In this page, we want to share everything we are working in.
We what to make high-value 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.
One of our goals is analyze our performance, learn and adapt to improve and get better results.
News
CT CURE extends expedited review of multinational clinical trial applications on COVID-19 therapeutics
The project seeks to include therapies that bridge the gap between therapeutic and preventive treatments for COVID-19 symptoms With this extended scope, CT CURE aims to engage new stakeholders interested in contributing to better prepare for future public health crises...
Contact