STAT Plus: Danish regulator eyes sanctions — including prison time — against trial sponsors that fail to post results
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 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.
