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SCORR Marketing and Applied Clinical Trials release the results of EU clinical trials survey.
SCORR Marketing released the results of a survey conducted with Applied Clinical Trials (ACT) that gathered industry input about the impact of the European Union (EU) clinical trials directive, and the placement of trials worldwide.
Recent changes in European clinical-trial regulations have reinvigorated discussion concerning locations of trials globally. Respondents from different areas of the drug-development industry-including sponsors, clinical research organizations (CROs), academic institutions, consultancies, and services providers-participated in the survey. Questions examined whether the regulations have affected the number of clinical trials taking place in Europe, if the intended benefits have been experienced, and which global regions are expected to experience increases or decreases in trials in the near future.
The EU Clinical Trials Directive was implemented in 2004 to simplify and harmonize clinical trial regulations, but only 52% of those surveyed feel it actually achieved this goal. In 2016, a new regulation, EU-CTR (EU) 536/2014, will be implemented.
“According to survey respondents, the overall benefit of the 2004 directive is uncertain,” said Lisa Henderson, editor in chief at ACT. “It will be interesting to see if the 2016 regulations will have similarly divisive results.”