European Union governments have given their support to pan-European legislation that would speed up authorisation procedures for clinical trials and ensure that all trials were registered in a central database and their results made publicly available.
The new legislation makes specific provision for “low intervention trials” (those that pose only minimal risk to safety of participants in comparison with normal clinical practice), clarifies the role of ethics committees in the authorisation process, strengthens rules on the protection of patients, and gives details of how to obtain informed consent.
Compulsory prior registration of all EU trials on the publicly accessible EU portal will bring more transparency to the conduct and results of clinical trials. Detailed summaries must be published once marketing authorisation for the tested drug is complete. Sponsors who fail to comply with these requirements face fines.
Read full article in the BMJ here
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