The fact that EMA has been making ‘clinical study reports’ (CSRs) available to independent researchers since 2016 is a positive development, with which EMA shows that it is serious about improving transparency. It means that independent researchers can now use the same data as the regulatory authority.
So far, only a few of these CSRs have been evaluated by independent researchers, but these few have yielded conclusions that differed from those of the regulatory authorities. This previously happened with antidepressants (Gebu 2016; 50: 129-130) and oseltamivir (Tamiflu®) (Gebu 2015; 49: 6-7). When the randomised trials that formed the basis for the authorisation of the antidepressant vortioxetine (Brintellix®) were examined by independent researchers, their conclusions turned out to be completely opposite to those of the authorities (Gebu 2016; 50: 65-74).
- Productinformatie duloxetine (Yentreve®), via: http://www.ema.europa.eu, EPAR’s.
- Maund E, et al. Considering benefits and harms of duloxetine for treatment of stress incontinence: a meta-analysis of clinical study reports. CMAJ 2017; 189: E194-203.
*The literature refers to the Dutch text