Tuesday, May 04, 2004

New measures to better protect clinical trial patients (UK)
Press release at the Department of Health web site - "New regulations which will better protect the rights, safety and well-being of patients taking part in clinical trials of medicines were welcomed today by Health Minister, Lord Warner. The measures are part of the 2001 EC Clinical Trials Directive, and will ensure that across the EU the danger to patients from poor clinical practice, research misconduct and fraud is reduced. Whilst most clinical trials conducted in the UK already meet internationally agreed standards of safety and quality, there are isolated cases of bad practice, such as patients taking part in trials who should have been excluded from doing so on medical grounds. The new regulations, which come into effect from 1st May, will strengthen the safeguards for patients. Under the Directive, all European clinical trials will have to be designed, conducted and reported in accordance with the principles of good clinical practice..."