Clinical trial authorisation applications
In 2014, the Danish Health and Medicines Authority received 284 applications for authorisation of clinical trials of medicines in humans, which is a decline of 3% compared to 2013. Commercial sponsors applied for 162 trials and researchers for 122.
It is positive that the level is comparable to 2013, when the number increased by 14%, and that the development in the number of trials since 2010 has been successfully reversed. In 2010, we received 226 applications. The decline may be explained by a lower number of applications for phase I trials.
Fall in the number of trial subjects
In 2014, 13,743 Danish trial subjects are expected to participate in 284 trials. This is a reduction of around 3,000 compared to 2013 (16,882), or 19% on 2013.
The average number of trial subjects per clinical trial dropped from 57 in 2013 to 48 in 2014. This downward trend can be traced back to 2011, when the average number of trial subjects was 76. The primary reason for the decline is that we have not received any applications for trials with more than 500 trial subjects.
Most trials in the therapeutic area cancer
Cancer-related trials account for 28% of all trial applications and 20% of all trial subjects.
Continued rise in the share of multinational trials
The share of multinational trials is increasing and accounts for 65% of all trial applications, and the number of national trials is declining. This underlines how important it is that the Danish authorities participate actively in influencing the European development in this area.
About clinical trials
Clinical trials are undertaken to find out how a particular medicine works, what side effects it causes and how it is metabolised in the body.
Trials are conducted on new medicines as well as medicines that are already on the market in Denmark.