Survey respondents: E.U. directive needs updating
SCORR Marketing, a global full-service marketing and communications firm, has released the results of a survey conducted with Applied Clinical Trials, a resource for professionals that design, initiate, conduct and monitor global clinical trials.
The survey gathered industry input about the impact of the E.U. Clinical Trials Directive (2001/20/EC) on the placement of trials not only in Europe, but also 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, 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 results of the survey uncover clinical trials trends in specific regions around the world,” said Joanna Disley, director of market intelligence and European operations at SCORR. “These are valuable insights we can pass on to our clients.”
The E.U. Clinical Trials Directive (2001/20/EC) was implemented in 2004 to simplify and harmonize clinical trial regulations, but only 52% of those surveyed feel it actually achieved the goal. In 2016, a new regulation, E.U.-CTR 536/2014, will be implemented.
“According to survey respondents, the overall benefit of the 2004 directive is uncertain,” said Applied Clinical Trials Editor-in-Chief Lisa Henderson. “It will be interesting to see if the 2016 regulations will have similarly divisive results.”