Annual report 2016 - Clinical trials of medicines
Last year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.
”We saw an increase in the number of planned trial subjects in 2016 of around 3,000 on Danish sites for trials authorised in 2016. Despite the fall in the number of clinical trial applications in 2016, we saw an increase of 16% in the number of planned trial subjects compared with 2015,” says Helle Harder, Head of Clinical Trials.
The cancer field continues to be the most frequent therapeutic area among clinical trial applications. The number of applications related to cancer in 2016 is largely unchanged compared to 2015.
In 2016, we saw an increasing number of amendment notifications regarding ongoing trials. The Danish Medicines Agency processed 803 amendments in 2016 compared with 699 in 2015, which is an increase of 15%.