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New PHG Foundation report calling for better evaluation of diagnostic tests generates huge media interest
The PHG Foundation and the Royal College of Pathologists recently co-hosted a two-day meeting of leading experts to discuss the evaluation of laboratory diagnostic tests and complex biomarkers. Although such tests are used routinely to diagnose patients and to predict the risk that someone who is currently well will develop a disease in the future, there are no formal guidelines in place to ensure that individual tests are safe and useful for the patient or their physician.
Launching the report of the meeting, PHG Foundation’s Director, Dr Ron Zimmern, said “In the UK, around 1 billion laboratory tests are performed each year. NHS laboratories have sophisticated systems to ensure the analytical accuracy of the tests, but no systems for ensuring that individual tests are clinically effective and useful. This is akin to pharmaceutical companies having tight control over the chemical purity of drugs, but there being no formal requirement for them to prove that the drugs produce any benefit for patients.” The report calls for a new body to be established to ensure the evaluation of laboratory diagnostic tests, and for the creation of a publically accessible database containing evidence of test performance, or lack of it, so that medical testing can be evidence-based. It also suggests that commissioners and health care professionals should be encouraged to use only those tests where appropriate evidence of clinical performance exists and that statutory regulators should call for a more responsive and proportionate risk assessment to ensure patient safety.
The report concludes that the processes recommended would not only assist health service professionals and patients, but would also provide much-needed clarity for commercial companies and academic researchers seeking to bring their innovations into NHS use.
The report, entitled “The Evaluation of Diagnostic Laboratory Tests and Complex Biomarkers”, is being published in tandem with a leaflet called “Making Sense of Testing” written by Sense about Science and aimed at the general public. The reports have received wide media interest, including an interview with Dr Ron Zimmern on the BBC Radio 4 Today program, articles in New Scientist, the Times, the Guardian and BBC News, and an editorial with accompanying paper in the BMJ.
The PHG Foundation and others will be attending a parliamentary briefing at the House of Commons in the afternoon of 11th March to discuss the report. This work will also feed into The House of Lords Science and Technology Committee inquiry into genomic medicine, for which the PHG Foundation will also be producing a formal response.