Concerns are being raised by a growing number of British academics that bureaucratic overload is stifling their ability to undertake clinical research, compromising the future of this activity in the UK, and ultimately doing patients a disservice. The issues are discussed in a Special Report in the August edition of The Lancet Oncology, written by freelance journalist Adrian Burton.
The implantation of European Clinical Trials Directive (ECTD), in 2004, has left researchers complaining that UK interpretation of the ECTD has led to the requirement of a detailed protocol (which might reach 100 pages in length) and the answering of over 40 questions on a form spanning 28 pages.
Michele Saunders (University College London, UK) complains that she has been trying for over 2 years to start a trial already well-established at another major hospital, but has been unsuccessful to date with no end in sight. "All was well before the European Directive came into action", she says. "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."
However, the chief executive of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Ken Woods says that the UK did not 'add' to the ECTD in interpreting it; and adds that UK researchers faced an increasing administrative burden due to the NHS research governance framework launched in 2001. And the Director of the National Research Ethics Service, Janet Wisely, says that the use of one form which can be sent to all appropriate regulatory bodies has streamlined research administration.
Such is the concern over delays that a group known as the Sensible Guidelines for Clinical Trials Working Group will hold its second meeting at St Anne's College, Oxford, UK; Sept 5, 2009. Organised by the Clinical Trials Service Unit at Oxford University, in conjunction with Duke University (USA) and McMaster University (Canada)—showing that UK academics are not alone in their concerns—the meeting will discuss the main areas preventing the efficient initiation and conduct of randomised trials, and discuss ways of overcoming these problems.
Burton 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."
Adrian Burton, freelance journalist, E) burtona@wanadoo.es / adrian@matheny.us
For full Special Report, see: http://press.thelancet.com/tloresearch.pdf
Journal
The Lancet Oncology