Regeldruk bij patiëntgebonden onderzoek

Edgar Smeets

Regulatory burden of clinical research

A few recent reports in both daily newspapers and interviews indicate that investigators working on trials in the Netherlands are experiencing too much red-tape, that regulations are getting too strict, and that they are being asked to do things which, in their view, are not really important. This impairs their efforts in delivering good research. Analysis shows that no new legislation has been introduced since the implementation of the EU Clinical Trial Directive in 2004. Over this 8-year period, the number of clinical research projects submitted nationwide has remained almost steady at approximately 1,800 per year. Of these a steady 42% are investigator-initiated studies. Recent new guidance from the FDA and MHRA indicates that over-interpretation of rules has indeed occurred. The newly promoted risk-based methodologies allow things to change. A potentially ‘leaner’ way forward has also been discussed.

Conflict of interest and financial support: none declared.