Evaluation is key to accelerated adoption of new diagnostics….

Written by Ray Waters on 10th June 2016

It is probably fair to say that since its genesis in September 2013, there are a still a fair number of people who do not know much about the NIHR Diagnostic Evidence Co-operative (DEC) Newcastle and what it does. So I was delighted to be invited by the AHSN to promote ourselves in one of their popular blogs.  So ‘what does a DEC do?’ I hear you ask. Put simply the DEC works with developers of diagnostic tests (technically, in vitro diagnostic medical devices (IVDs))* to develop and conduct scientific studies that will provide robust evidence on how accurate the test is, how it can benefit patients and/or the NHS, and what value it provides for the money needed to invest in it, and how affordable it is for society and health care providers such as hospitals, GP practices, and social care services.

By undertaking clinical studies involving patients, or studies modelling changes in clinical practice, the DEC takes tests through a process of rigorous clinical and economic evaluation. This objective, high-quality evidence can then be used by companies to demonstrate the value of their product to the NHS: commissioners and mangers and clinicians.

The National Institute for Health Research is funding four DECs until August 2017, the others being based at Leeds, Oxford, and London (Imperial College). Each DEC has its own research specialism, and the Newcastle DEC focuses on the clinical research excellence available in Newcastle University and Newcastle NHS Hospitals in areas such as liver, infectious diseases, cancer, and molecular genetics.  However, when the Newcastle DEC started it was essentially based around one person, our Deputy Director Dr Michael Power, with the support of a dedicated DEC Management Group led by the Director Professor John Simpson.  Since then the Newcastle DEC has grown and developed the skills and expertise needed to provide IVD developers with a world class service. In house we have a team of four multi-disciplinary evaluation methodologists, project manager, and industry liaison lead. In addition we work closely with biostatisticians, health economists, a range of service and research laboratories, clinicians and managers. This capacity provides us with the in-house expertise to work with a wide range of companies to undertake sophisticated, independent and objective evaluation of their diagnostic technologies in a wide range of clinical settings.  I think it’s an understatement that the average day of one of the evaluation methodologists is not a dull one.  We receive enquiries from companies on a wide range of diagnostic technologies, one moment we could be dealing with a point of care test for flu, employing a molecular detection technology; the next moment we could be evaluating a test measuring a biomarker and developing a score to better predict the potential for deterioration of an acutely ill patient’s condition.

The DEC has also been particularly fortunate to receive support from the AHSN to increase its industry engagement, and to enable it to play a key role in their Innovation Pathway. This enables the DEC to be part of an integrated mechanism of innovation support for companies, and to share enquiries between the other partners in the pathway. In February the DEC hosted ‘Adopting MedTech 2016’ our main industry engagement event. Industry delegates were fortunate enough to hear from George Freeman MP, Minister for Life Sciences, and Prof. Sue Hill, Chief Scientific Officer, NHS England, deliver the keynote speech on the NHS’ strategy for personalised medicine.

In common with all people working on the health agenda, the work we conduct is firmly aimed at benefitting patients. The primary goal of the DECs is to generate evidence which will facilitate the introduction of diagnostic tests into the NHS that demonstrate patient benefit and are cost effective. As Prof Sue Hill highlighted at ‘Adopting MedTech 2016’, the use of new diagnostic technologies to better stratify patients is becoming increasingly important in order that approaches in personalised medicine can more effectively be delivered. The engagement and involvement of patients and members of the public is therefore a highly significant element of our work, and we are lucky for this this to be facilitated locally by the Voice North (VN) Research Support Group. This group consists of a highly experienced and dedicated group of individuals that can advise us on study design, preparation of lay summaries and help ensure that we remain patient focused in our work!  In conjunction with VN Voice North and the Newcastle University Faculty of Medical Sciences’ Engagement Team the DEC helped deliver the ‘Diagnosis Matters’ public engagement event, of which you can read more in an earlier blog by Seamus, which also had the bewildering sub-title of ‘A chimp, Mary Berry and the Jesuits’.

If you would like to learn more about the work of the NIHR DEC Newcastle please see our website or read one of our industry case studies

* in vitro diagnostics (IVDs), as if you didn’t already know, is a test that is conducted outside of the body on a specimen taken from the body, such as blood, sputum, stool, urine or tissue. Thankfully we leave handling these substances to the healthcare professionals and laboratory staff!