Annual report on clinical trials of medicines in humans 2012

25 October 2013

The number of clinical trial applications is at the same level as in 2011

In 2012, the Danish Health Authority received 259 applications for clinical trials, 12 trials down compared to 2011. The number of trials sponsored by companies appears to have stabilised around 150 trials per year.

The number of subjects to participate in trials sponsored by researchers is significantly higher than the number of subjects to participate in trials sponsored by companies

It is estimated that 19,150 Danish trial subjects will participate in the 259 trials that were applied for in 2012. It is estimated that 8,605 trial subjects will participate in the 153 trials sponsored by companies, whereas 10,535 will participate in the 106 trials sponsored by researchers. The average number of subjects per trial is 74. The report breaks down the trial subjects on number of trials and therapeutic areas.

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

160 of the 259 trials planned to take place in Denmark will be conducted in several other European countries. Whereas 94% of the commercial trials are multinational, this is only the case for 15% of the trials spon¬sored by researchers. The number of multinational trials sponsored by researchers has fallen by 40%.

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

The Danish Health Authority has met 98% of the fixed assessment times, and 10% have been reviewed through the common European Voluntary Harmonisation Procedure (VHP). From April 2012, the Danish Health Authority has offered shorter assessment times for applications suitable for risk-adapted assessment. The use of this offer has been limited, but it is expected to grow in line with increasing awareness of the offer.

The annual report presents several data on trials notified in 2012. You can also read about the application portal shared with the ethics committees that we will launch in the autumn of 2013, introducing format requirements for clinical trial applications as well as the European Commission's proposal for a clinical trials regulation released in July 2012.