What is the European equivalent of Clinicaltrials?
EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database for all interventional clinical trials on medicinal products authorized in the European Union (EEA) and outside the EU/EEA if they are part of a Paediatric Investigation Plan (PIP) from 1 May 2004 onwards.
How many clinical trials are in Europe?
The impact of clinical trialsAccording to the European Medicines Agency (EMA), around 4,000 trials are authorised each year across the EEA and this phenomenal effort, in partnership with other global research partners is transforming the way we care for patients and treat many diseases.
What is a clinical trial application in Europe?
Clinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational medicinal products (IMPs). A streamlined application procedure for all clinical trials conducted in Europe via a single EU portal and database. …
What are the benefits of the EU CTR?
improved collaboration, information-sharing and decision-making between and within Member States; increased transparency of information on clinical trials; highest standards of safety for all participants in EU clinical trials.
What countries are apart of the EU?
The EU countries are: Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
What is a clinical trial registry?
A patient registry is “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition or exposure, and that serves a predetermined scientific, clinical or policy purpose.”
What is EMA in clinical research?
The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. It also manages a database of clinical trials carried out in the European Union (EU).
Who approves clinical trials in Europe?
In Europe clinical trial approval is granted by a regulatory authority and requires favourable opinion by a Research Ethics Committee (REC). The CT Directive set out the minimum requirements for clinical trials with a specific sub-category of medicines called ‘investigational medicinal products’ (IMPs).
Who approves a clinical trial?
Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community.
When was the EudraCT clinical trials database established?
EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database for all interventional clinical trials on medicinal products authorized in the European Union (EEA) and outside the EU/EEA if they are part of a Paediatric Investigation Plan (PIP) from 1 May 2004 onwards. It has been established in accordance
Where are clinical trials conducted in the EU?
interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA); clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
Where can I find information on clinical trials?
The EU CTR contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004. The Register enables you to search for information in the EudraCT database.
How old are the patients in the EudraCT trials?
The EU Clinical Trials Register currently displays 35535 clinical trials with a EudraCT protocol, of which 5839 are clinical trials conducted with subjects less than 18 years old.