When the CTD came into effect on May 1, 2004, there were concerns that the imposition of Good Clinical Practice standards on independent researchers - bringing them into step with their colleagues in the pharmaceutical industry – would put a damper on public research.
One of the chief reasons behind the concerns was the volume of paperwork required under GCP for monitoring and audit purposes, which some were concerned would be too onerous for public institutions with limited resources.
An editorial published in The Lancet in 2003 went so far as to ask whether the CTD would be ‘the death of academic clinical trials’, and there were numerous accusations that adding GCP would add to bureaucracy without necessarily improving higher quality.
Now, a study published in the British Medical Journal (August 20) has concluded that for Denmark those fears were unfounded.
The study looked at the total number of paper and electronic applications for clinical trials with medicinal products submitted to the Danish Medicines Agency between 1993 to 2006. From 1993 to 2005, there was a steady downward trend in the number of clinical trials initiated by both researchers and companies, although the number increased in 2006.
Crucially, there was no significant difference between the number of academic and industry studies, indicating that “academic researchers can match the demands for the good clinical practice quality standard that industry have adhered to for many years.”
Allocation of resources critical
However, the authors of the study also note that Denmark differs from some other countries in Europe, such as Austria which has seen a decline in academic research since the CTD, in that it has allocated resources for GCP units.
“In Denmark the universities and university hospitals fund good clinical practice units that provide free assistance to academic clinical researchers,” according to the researchers, headed by Henrik Enghusen Poulsen of the University of Copenhagen.
“We believe that such units and the focus on available expertise for the good clinical practice quality standard to academic researchers can explain the difference in trend of academic clinical research between Austria and Denmark.”
Since its implementation the CTD has not been without its critics. Last year, the UK's BioIndustry Association and its European parent EuropaBio called for changes to be made to the directive in order to bring about "harmonisation, transparency and consistency" in this area across the member states.
The BIA took particular issue with the bureaucratic burden it believes the CTD brings for small and medium-sized enterprises, given that different member states can interpret the requirements in different ways.