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Evaluating New Diagnostic Technologies: Perspectives in the UK and US

¹ Department of Clinical Biochemistry, University of Oxford, John Radcliffe Hospital, Oxford, UK; ² Department of Pathology, University of Maryland School of Medicine, Baltimore, MD.

^aAddress correspondence to this author at: Department of Clinical Biochemistry, University of Oxford, John Radcliffe Hospital, Headington, Oxford, OX9 3DU, United Kingdom. E-mail cpprice1@gmail.com.

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In March 2008, Lord Darzi, a Parliamentary Under Secretary of State for Health in the UK, announced formation of a Health Innovation Council "to act as an overarching guardian for innovation from discovery through to adoption" for new diagnostic technologies, while also "holding the Department of Health and the National Health Service to account for helping to overcome barriers and taking up innovation."

In 2001 the Institute of Medicine in the US attributed shortcomings in the quality of health care to 4 main reasons: (a) the growing complexity of science and technology, (b) the increase in chronic conditions, (c) a poorly organized delivery system, and (d) constraints on exploitation of the revolution in information technology. The Institute concluded that science and technology have advanced more rapidly than the ability of health care systems to deliver them safely, effectively, and efficiently, and proposed a number of initiatives to address these issues. The emphasis on these themes in the UK and the US are indicative of the poor state of translational research in medicine, a situation that is probably reflected in many health systems across the world, and equally so in laboratory medicine. Concerns about the quality of health care point to the need for a greater focus on outcomes research—a call made by George Lundberg for laboratory medicine several years ago (1). This issue was recognized in the UK in a report published recently by the Royal College of Pathologists and the Foundation for Genomics and Population Health (2).

In the UK there is no formal system for evaluation and adoption of new diagnostic tests, although the Department of Health is sponsoring a health technology assessment program. Regulation is covered by a European Directive, CE marking (Conformité Européenne. . . [Full Text of this Article]

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				J. G. Lijmer, M. Leeflang, and P. M. M. Bossuyt Proposals for a Phased Evaluation of Medical Tests Med Decis Making, September 1, 2009; 29(5): E13 - E21. [Abstract] [PDF]