British academics are warning that the ability to undertake clinical research is being stifled by red tape.
They say the implementation of the European Clinical Trials Directive (ECTD), in 2004, has created too much bureaucracy and is compromising medical research in the UK.
Under the UK’s interpretation of ECTD rules, a detailed protocol - which might reach 100 pages in length - has to be produced and over 40 questions have to be answered on a 28-page form.
University College researcher Michele Saunders says in The Lancet Oncology report that she has been trying for over two years to start a trial already well-established at another major hospital, but has been unsuccessful to date with no end in sight.
She said: “All was well before the European directive came into action. The regulations are law in some cases and this has made those with responsibility nervous, there’s so much documentation for everything. The culture of blame in this society does not help.”
The report concludes: “Clearly, approval authorities and researchers are only trying to do their jobs - some on a volunteer basis. But if clinical research is being delayed and there is a real danger of its future being compromised, then researchers, approval bodies, and policymakers need to foster better partnerships to develop more effective and efficient integrated solutions as soon as possible.”
However, Ken Woods, chief executive of the Medicines and Healthcare Products Regulatory Agency, said that the UK’s interpretation of the ECTD did “not add” to its bureaucracy. “UK researchers already faced an increasing administrative burden due to the NHS research governance framework launched in 2001,” he said.
A new body called Sensible Guidelines for Clinical Trials Working Group is due to hold its second meeting in September, in Oxford, to discuss how to get randomised trials off the ground.
Read the full report.
Tags: Research
