Our new paper, "The evidence base for psychotropic drugs approved by the European Medicines Agency [EMA]: a meta-assessment of all European Public Assessment Reports" is now out. This was a huge effort to collect and analyse the data. Still, the process is ongoing as retrieving study reports proved to be difficult (i.e. long... very long) despite EMA's commitment to transparency.
What did we learn ? Well... the evidence for psychiatric drug approved by the EMA was in general poor, especially when considering comparative effectiveness issue. Small to modest effects v. placebo were considered sufficient in indications where an earlier drug exists.
What's next ? The next steps in our project are to finish data collection and extraction, to share an online interactive tool monitoring EMA’s approvals of psychotropic medication and to update our database with the most recent approvals. Developing the tool in other indications/disease may also be of interest as it may increase transparency. Continuous monitoring of health authorities (such as the EMA) should motivate the definition of high standards, so as to drive the research agenda and avoid wasted efforts, and to reduce persistent uncertainties.
Improvements are needed. First, EPARs should include proper meta-analyses, with data sharing of all aggregated data in a structured form allowing a complete overview of the evidence base for approved drugs. Ideally, to provide complete transparency, these meta-analyses should be prospective (prior to the RCTs). With Ioana A. Cristea, we have recently proposed a model of ‘registered drug approvals’ following the data-blind peer-review model of registered reports.
We are looking forward to discuss these issues with the EMA.
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