Yesterday, the Public Health Committee endorsed new draft EU rules on clinical trials of new medicines. Since the past years showed a decline in the number of conducted clinical trials in the EU, there is a clear need to change the rules that could have been responsible for this (e.g. the existing Directive 2001/20 is said to unnecessarily increase bureaucracy, overlook the option of non-commercial clinical trials). The new rules are to increase the transparency by making it mandatory to publish detailed summaries in publicly accessible EU database, with full Clinical Study Reports published once a decision on authorisation is complete. There would be a new rule on compensating damages, pursuant to which low-risk clinical trials could be covered by the general compensation system of a health care system. Additional provisions would regulate the ethics of conducting clinical trials on certain patients. (Clinical trials: clearer rules, better protection)Thursday 30 May 2013
Trying for better clinical trials
Yesterday, the Public Health Committee endorsed new draft EU rules on clinical trials of new medicines. Since the past years showed a decline in the number of conducted clinical trials in the EU, there is a clear need to change the rules that could have been responsible for this (e.g. the existing Directive 2001/20 is said to unnecessarily increase bureaucracy, overlook the option of non-commercial clinical trials). The new rules are to increase the transparency by making it mandatory to publish detailed summaries in publicly accessible EU database, with full Clinical Study Reports published once a decision on authorisation is complete. There would be a new rule on compensating damages, pursuant to which low-risk clinical trials could be covered by the general compensation system of a health care system. Additional provisions would regulate the ethics of conducting clinical trials on certain patients. (Clinical trials: clearer rules, better protection)
