Abstract
The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice. In this contribution, we argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union's Clinical Trial Regulation No. 536/2014.
Highlights
In recent years, the value of pragmatism in clinical trials has been strongly emphasised
The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice
We argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union’s Clinical Trial Regulation No 536/2014
Summary
The value of pragmatism in clinical trials has been strongly emphasised. Applications for clinical trials in the EU progressively decreased (European Commission, 2012), until a new regulation, called Clinical Trial Regulation No 536/2014, was issued (The European Parliament and the Council of the European Union, 2014) Novel aspects of this regulation include harmonised electronic submission and assessment processes between EU member states; faster and centralised submission and assessment of trials’ protocols; improved information sharing and decision making between and within EU member states; economic facilitations (e.g. concept of co-sponsorship); highest safety standards for patients; increased transparency of information on clinical trials (Gokhale and Berry, 2018; Tenti et al, 2018; Scavone et al, 2019). We briefly describe a pragmatic clinical trial on antidepressants currently ongoing in Italy, as this represents a case-example of the practical consequences of a lacking implementation of the last EU regulation
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