The European Medicines Agency supports International Clinical Trials Day, which is taking place on Sunday 20 May 2012.
International Clinical Trials Day aims to enhance communication and coordination of clinical trials between countries, resulting in better clinical research that is relevant to the needs of patients everywhere. It is celebrated every year on or around 20 May, commemorating the day that James Lind started his famous trial comparing treatments for scurvy on 20 May 1747.
The majority of the Agency’s scientific work is centred on the review, coordination and supervision of clinical trials:
- its scientific evaluation work involves the review of clinical-trial data that are included in the application information from a pharmaceutical company when seeking marketing authorisation;
- it provides scientific advice on the design of clinical trials conducted as part of medicine development and decisions on clinical-trial design as part of paediatric investigation plans (PIPs);
- it provides scientific guidance on the design and conduct of clinical trials in specific therapeutic areas;
- it has a central role in ensuring application of good clinical practice (GCP) at a European Union (EU) level. GCP is the international ethical and scientific quality standard for designing, recording and reporting clinical trials that involve the participation of human subjects.
The Agency hosts the EU clinical trials register on behalf of EU Member States. This website contains information on interventional clinical trials of medicines, allowing users to view descriptions of clinical trials being conducted in the EU, as well as Iceland, Liechtenstein or Norway, and descriptions of trials forming part of a PIP including those where the investigator sites are outside the EU.
The Agency is also responsible for the development, maintenance and coordination of the EudraCT database, an application used by national medicine regulatory authorities to enter clinical trial data from clinical trial sponsors.
The Agency expects clinical trials carried out in countries outside the EU submitted in marketing-authorisation applications to EU regulatory authorities to meet the same ethical principles and standards as those performed within the EU. In response to this challenge, the Agency recently published a reflection paper offering practical guidance on how clinical trials outside the EU should be conducted, when data from these trials is included in marketing-authorisation applications submitted in the EU.
The paper puts forward concrete steps for international cooperation in the regulation of clinical trials, with a specific emphasis on capacity-building initiatives for a common approach to oversight of trials.
It also clarifies and determines the practical steps by which EU regulators will gain assurance that ethical and GCP standards are applied to clinical trials for human medicines, both during the development and during the marketing-authorisation-application phase. It also promotes greater transparency regarding the evaluation of these matters during the marketing-authorisation phase.