Diagnostic Evidence Co-operative Newcastle

Creating an evidence development strategy In order to bring your test or device to market, and to adoption in the NHS, you need high-quality, robust evidence of its performance, usability, safety, benefits, and value for money. The NIHR DEC Newcastle can work with you to understand where in the evidence development pathway your device currently is, and help optimise your evidence development strategy.

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Performance reliability

Diagnostic accuracy

Value (actual)

Patient benefit

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Adoption

Understanding the evidence development pathway Just as the technical development of a device is carried out in stages, the generation of evidence supporting that device must also pass through a number of stages, or the evidence development pathway.

Value (potential) It is vital to establish the potential value of your device, or test, as early as possible in the development process. Key questions to be answered include: What is the potential market size and your likely share? How will your test change current care pathways? Who will use your test? What potential barriers to adoption need to be addressed (for example training, acceptability of the test and its results to clinicians, budget silos, etc.). It is helpful to engage with clinicians, and patient groups at an early stage to assess these factors — the DEC can facilitate this.

Performance reliability This encompasses the laboratory (bench) validation carried out before the device is evaluated with clinical samples in its intended setting and from its intended patient population. This will provide answers on the accuracy, precision, limits of detection, and repeatability of the test. The device developer would usually seek regulator’s approvals such as CE marking during this performance reliability phase.

www.newcastle.dec.nihr.ac.uk | [email protected] |

@NIHR_DEC_Ncl

The NIHR Diagnostic Evidence Co-operative Newcastle is delivered in partnership between Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University

Diagnostic accuracy This is the first stage of testing in the “real world”, i.e. in the setting, and patient population that the device is intended for. This stage aims to compare the diagnostic accuracy of the new test, to the best one that is currently used (the reference standard). Key questions to be answered include: What are the sensitivity and specificity? What are the predictive values (for relevant prevalence)? What are the uncertainties in these measurements of diagnostic accuracy? Patient benefit The key questions at this stage are about: What’s in it for me (benefits)? And what am I in for (harms and costs)? What difference does the test make to the patient? For example, in terms of the patient clinical journey, do they receive moretailored treatment, or earlier treatment, and/or is their eventual outcome better?

Working towards your evidence development strategy The NIHR DEC Newcastle can work with you to understand the evidence you already have, and to outline the evidence needed to achieve NHS and wider market adoption of your product. One commonly used approach to identifying the most relevant studies is to tabulate, at each stage along the evidence development pathway, what your key value propositions are. This requires careful attention to the full range of stakeholders who are involved in decisions about using or investing in your product. They may include patients, clinicians, pathologists, laboratory managers and technicians, and commissioners.

Value (actual) The key questions at this stage are around the concerns: Would investing in this product provide value for money? Is adopting this product affordable? Both these questions require answers from relevant declared perspectives, for example: the NHS (as is done in evaluations conducted by NICE) or healthcare providers (as is done in budget impact assessments). Human factors and usability The key question at this stage is: What pitfalls do people discover when they use the product?

www.newcastle.dec.nihr.ac.uk | [email protected] |

@NIHR_DEC_Ncl

The NIHR Diagnostic Evidence Co-operative Newcastle is delivered in partnership between Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University