In the latest effort toward greater clinical trial transparency, the Danish Medicines Agency is threatening to pursue sanctions — including fines and prison sentences —against drug companies and universities that fail to publish their study results in a European database, as required.
Under the current legal framework in Denmark, clinical trial sponsors that do not report results on time can be fined or given a prison sentence of up to four months. Although some drug makers and universities responded to a reminder warning issued last fall, most trial results have still not been posted as required and so the agency will approach the public prosecutor about penalties.
Last November, the agency noted only 24% of non-commercial sponsors, such as universities, had published trial results. This followed a letter issued last July by the European Medicines Agency and the Heads of Medicines Agencies, an umbrella group for 40 European Union countries, to remind trial sponsors to publish results. At the time, compliance among industry was much higher, at 77%.