The efficiency and transparency of clinical drug trials in the Netherlands must improve. That concludes Sander van den Bogert in his PhD thesis ‘Trials & Tribulations. Studies on the fate, transparency and efficiency of clinical drug trials’. On October 4th, he will obtain his PhD at Utrecht University.
Approximately 600 clinical drug trials are evaluated annually in the Netherlands by the accredited Medical Research Ethics Committees (in Dutch: METCs) and the Central Committee on Research Involving Human Subjects (in Dutch: CCMOCentral Committee for Research involving Human Subjects ). Within the framework of a collaborative project between RIVMNational Institute for Public Health and the Environment , Utrecht University and the CCMO, Van den Bogert examined what steps are taken in the trials once they have been positively evaluated. In addition, he investigated how data routinely collected by regulatory authorities can be used to increase regulatory efficiency.
The study shows that from all clinical drug trials evaluated by the METCs and CCMO in 2007, 45% was completed and published in the scientific literature according to the reviewed protocol. This implies that the ethical norm that states that all studies involving research subjects should be published is often not met. In addition, it is likely that many studies are not published because the results do not match the predictions or expectations of the researchers or sponsors. The probability of bias in the scientific literature on medicines is therefore high. Further measures to improve the transparency of clinical drug research are needed.
Prior to the defense of Van den Bogert’s thesis, a symposium will be held in Utrecht, where speakers will discuss the issues of efficiency and transparency of clinical drug research from various perspectives.