Regulation—the real threat to clinical research

Personal experience and feedback from many clinical researchers indicates that a major hurdle to undertaking clinical research is the ever increasing bureaucracy attached to the process. It is now the biggest single threat to the UK clinical research base and warrants immediate action. Earlier threats—lack of researchers and capacity—have been addressed through major investment by interested parties including the Medical Research Council, Wellcome Trust, other charities, and the Department of Health. However, anyone taking up one of the new academic specialist registrar posts created to encourage clinical academic training is likely to spend the entire 12 month fellowship trying to obtain regulatory approval for any clinical research project. Drug companies are experiencing similar difficulties. The UK has slipped from one of the most attractive to one of the least attractive places to undertake clinical trials as a result of ignoring warnings at the start of the decade that companies cannot afford long delays in approval and initiation.1 2 We illustrate the effect of recent regulation with two anecdotes from our experience.