Rejected applications for drugs authorisation and publications in peer-reviewed journals

The study discussed here shows that the regulatory authorities currently reject about half of all applications for market authorisation of drugs examined in Phase III studies, mostly due to doubts about their efficacy and/or safety. This information is very important for the debate about the European Medicines Agency’s plan to speed up the market authorisation, for instance by means of ‘adaptive licensing’ procedures (Gebu 2015; 49: 136). In this procedure the manufacturer does not have to submit as many research data on efficacy and side-effects as in the current system. From the point of view of patient safety, this is an undesirable development.

  1. Hwang TJ, et al. Failure of investigational drugs in late-stage clinical development and publication of trial results. JAMA Intern Med 2016; 176: 1826-1833.

*The literature refers to the Dutch text