The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the Danish Health and Medicines Authority's annual report 2013 on clinical trials of medicines in humans.
Doubling of phase 1 trials
A targeted focus on attracting clinical trials in phases I and II to Denmark now seems to have an effect. The number of phase I trials doubled from 20 to 40 trials from 2011 to 2013. The number of phase II trials increased by 19 from 2012 to 2013.
More trials with fewer trial subjects
The total number of Danish trial subjects in the 294 trials is 16,882. This is significantly fewer than in the past two years when the number of trial subjects was around 19-20,000. The average number of subjects per trial is 57, compared with 74 in 2012.
More multinational trials authorised under voluntary harmonisation procedure
Around two thirds of the trials planned to take place in Denmark will be conducted in several other European countries. The number of applications for multinational trials reviewed through the common European Voluntary Harmonisation Procedure (VHP) almost doubled and now account for 25%.
What is a clinical trial?
Clinical trials are conducted for a range of purposes, such as obtaining new, or verifying existing, knowledge about how a specific medicine works on humans and the side effects it causes. The people who participate in clinical trials of medicines, are volunteers, and they give their consent before the treatment starts. The Danish Health and Medicines Authority and the research ethics committee must give authorisation to the conduct of clinical trials of medicinal products in humans.
Clinical trials of medicines are conducted in all phases:
- The first trials of new medicines are termed phase I and phase II trials and are most commonly conducted on a small number of trial subjects.
- Phase III trials are conducted ahead of the marketing of a new medicine, involve a larger number of trial subjects and make comparisons with existing treatment.
- Phase IV trials are conducted on medicines with a marketing authorisation for the disease the relevant medicine is intended for.
Annual report 2013 on clinical trials of medicinal products