The impact of the 'Clinical Trials' directive on the cost and conduct of non-commercial cancer trials in the UK.

BACKGROUND The UK Medicines for Human Use (Clinical Trials) Regulations 2004 implemented the European 'Clinical Trials' Directive (2001/20/EC) (EUCTD) into UK law and came into effect on 1(st) May 2004. In the period leading up to the implementation of the EUCTD in the UK there were serious concerns that it would have major cost implications for academic units running non-commercial clinical trials. METHODS Directors and senior staff in 8 Clinical Trials Units (CTUs) were contacted and invited to participate in the study; arrangements were made for face-to-face interviews and the units were sent a questionnaire in advance of the meeting. The questionnaire was divided into six sections covering their involvement in non-commercial cancer clinical trials, and their perceptions of the EUCTD and its impact on all stages of trial development and conduct. Detailed cost data were also collected. FINDINGS The findings from the questionnaire and interviews indicate that the EUCTD has resulted in a doubling of the cost of running non-commercial cancer clinical trials in the UK and a delay to the start of trials. The lack of central guidance, lack of clarity regarding the interpretation of the guidance notes, and increase in essential documentation and paperwork were causes of major concern for experienced staff who were anxious about whether they were interpreting the Directive correctly. Moreover, the CTUs were unable or unwilling to open trials in non-UK centres because of the different interpretation of the EUCTD by member states. INTERPRETATION The EUCTD has both increased the cost and caused delay to non-commercial cancer clinical trials run by major public sector Clinical Trials Units in the UK. Staff have felt that they were working beyond capacity and were feeling demoralised in many CTUs. Finally, rather than harmonising and simplifying the regulatory environment, the Clinical Trials Directive has stopped many units from running trials in international centres. The UK has taken action to address some of the problems identified by this and other research, but problems remain.