Annual report 2013 clinical trials of medicines in humans

03 July 2014

The Danish Health Authority has published its annual report 2013 on clinical trials of medicines in humans.

Link

Annual report 2013 on clinical trials of medicines in humans

Highlights

In the Danish Health Authority’s annual report 2013 on clinical trials of medicines in humans you can read more about:

The number of clinical trial applications increased by 14% from 2012 to 2013

In 2013, the Danish Health Authority reviewed 294 applications for clinical trials, 35 trials more than in 2012.

The number of notified trials sponsored by researchers increased from 106 to 129. This increase exceeds the rise in the number of trials sponsored by companies, which rose from 153 to 165 in the period from 2012 to 2013.

More trials were notified but with fewer subjects in 2013

The Danish Health Authority estimates that 16,882 Danish trial subjects will participate in the 294 trials that were applied for in 2013. This is significantly fewer than in the past two years when the number of trial subjects was around 19-20,000.

It is estimated that 7,748 trial subjects will participate in the 165 trials sponsored by companies, whereas 9,134 subjects will participate in the 129 notified trials sponsored by researchers. The average number of subjects per trial is 57.

In 2012, the average number was 74. Thus, more trials were notified but generally with fewer participants. The report breaks down the trial subjects on number of trials and therapeutic areas.

The number of phase I trials doubled in three years

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.

Two thirds of the trials conducted in Denmark are also conducted in other European countries

The majority (177) of the 291 trials planned to take place in Denmark will be conducted in several other European countries. Whereas 90% of the commercial trials are multinational, this is only the case for 22% of the trials sponsored by researchers.

Assessment times are being met and an increasing number of trials are coordinated with other European authorities

The Danish Health Authority met 88% of the fixed assessment times, and 25% of the applications were reviewed through the common European Voluntary Harmonisation Procedure (VHP).

The annual report presents several data on trials notified in 2013. You can also read about the application portal shared with the ethics committees as well as the recently adopted European clinical trials regulation.

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