Charities warn patient safety is compromised by research red tape

Patient safety and treatment advances are being compromised by a 15% year-on-year rise in regulatory bureaucracy, research charities have warned.

A statement on the problems caused by disproportionate regulation of European clinical trials has been issued by 16 organisations.

It calls on the European Commission to streamline the approval process for clinical trials and to reduce variation in how European regulation of research is interpreted in different countries. Signatories included Cancer Research UK, the British Heart Foundation, the Wellcome Trust and the Academy of Medical Sciences.

The research organisations warn that administrative costs rose 75% over four years, equivalent to a 15% year-on-year rise. In addition, there has been a 65% increase in the time it takes researchers to receive approval for their studies.

Academy of Medical Sciences president Professor John Bell said regulation had to both protect patients and facilitate research. ‘The current regulation of clinical trials in Europe is causing unnecessary delays and complexity which is stifling medical advances, without additional benefits to patient safety,’ he said.

Betty McBride, policy and communications director at the British Heart Foundation, commented: ‘Our researchers have told us that it’s becoming more and more difficult to carry out clinical research in the UK due to the over burdensome regulation and that it may prove a disincentive to them continuing a research career.

‘The Commission and parliament need to seize this opportunity to reform the directive, and ensure clinical trials are conducted safely and to high standards without overwhelming researchers with red tape.'

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