The long-awaited European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) will come into effect in early 2022. The CTR is intended to improve the submission and review processes for clinical trials via a centralized portal. In recent weeks, the European Medicines Agency (EMA) has confirmed that the clinical trial EU Portal and Database, the key component of the Clinical Trial Information System (CTIS), is complete and proposed a go-live date of 31 January 2022. In this article Cromos Pharma looks forward to the full implementation of the CTR and explores how it will affect the conduct of clinical trials in the EU.
The implementation of the CTR will bring about significant changes to the way clinical trials are conducted in the EU. It 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. Under the current Clinical Trials Directive, rules about the conduct and assessment of clinical trials vary from member state to member state.
The CTR aims to bring about a cohesive and favorable environment across the entire EU for the conduct of clinical trials. It will promote the highest standards of patient safety while creating greater transparency of trial information. It requires consistent rules for conducting clinical trials and that information about authorization, conduct and the results of trials will be made publicly available. It aims to increase efficiency of clinical trials and will harmonize the rules for conduct across the EU.
The CTIS will be the single point of entry for the submission of all information about clinical trials in the EU. The clinical trial application form will contain all necessary regulatory and ethics approvals as well as updates on clinical trials. The EMA will make all information publicly available in line with pre-agreed transparency rules.
According to the EMA:
“The system will support the day-to-day business processes of member states and sponsors throughout the life-cycle of a clinical trial in a user-friendly way. It will provide regulatory oversight of clinical trials and tools for supervision and monitoring, and will contain collaboration tools, workflow and document management capabilities, accessible via individual workspaces”.
It is likely that adaption to the CTR will be a learning curve for all involved in clinical research but once successfully in operation will deliver many advantages to sponsors and assessors.
Cromos Pharma’s team can assist in smoothing the transition to the EU CTR by advising on protocol language and necessary new processes.
Cromos Pharma is delighted to be taking part in the upcoming DIA Europe conference (15 – 19 March 2021) and BIO-Europe Spring (22-25 March 2021).
February 11th is International Women and Girls in Science Day. A joint UNESCO and UN-Women initiative, it aims to promote the role of #WomenInScience and to challenge some of the barriers to girls pursuing a career in science.
Are you a sponsor seeking to conduct clinical trials in the European Union but do not have a registered office in the European Economic Area? If so, in order to comply with the European Union Clinical Trial Directive, you are required to work with a Legal Representative registered in an EEA country.
Each 4th February, #WorldCancerDay aims to raise awareness of the global personal, social and economic burden of cancer. World Cancer Day was established in Paris at the first World Cancer Summit in 2000.
As 2021 begins, many countries are grappling with a renewed surge of COVID-19 infections necessitating further public health restrictions putting more pressure on health systems, societies and global economies. The task of rolling out approved vaccines is increasingly urgent. Almost 16 million doses of COVID-19 vaccines have been administered to date in 37 countries worldwide according to data compiled by Bloomberg ( updated 7 Jan 2021).
Tuesday 1 December marked World AIDS Day 2020. Although throughout this year our focus has been on the coronavirus pandemic, World AIDS Day is an opportunity to reflect on another pandemic where a virus passed from animals to humans with devastating consequences. To date 77 million people worldwide have been infected with HIV. In spite of innovative new treatments 35 million people have died from the virus.
If you missed the live webinar “Where in the world should I locate my pivotal clinical trial?” you can now watch the recording by clicking here. The webinar hosted by the Society of Physician Entrepreneurs (SoPE) and Workforce Genetics features Cromos Pharma's CEO Vlad Bogin, M.D, FACP.