The NIHR DEC In Vitro Diagnostic Evidence Generation Pathway has been created to enable companies to generate the
right evidence that will facilitate successful uptake of commercial IVDs
INVENTION
IVD Developers
Include:
•Industry
•Academia
•NHS
Selection, modelling
& prioritisation
ADOPTION
EVALUATION
DIFFUSION
Diagnostic Evidence Co-operatives Expertise & Resources
NIHR Diagnostic Evidence Co-operatives enable experts from across the NHS and industry
to collaboratively generate clinical validity, clinical utility, cost-effectiveness and care
pathway benefits of IVDs.
This level of collaboration has the potential to lead to improvements in healthcare services
and the quality of life of NHS patients, by helping patients access the most appropriate
treatments more quickly and help the NHS make the best use of its resources.
DEC access to clinical expertise and resources
research sites, biobank samples & data, databases
All NIHR DECs work closely with the NIHR Office for Clinical Research Infrastructure
(NOCRI) and link with other NIHR-funded research infrastructure.
Analytical &
clinical validity
assessment
Assess
current clinical
care pathway
and propose
changes
(where
appropriate)
Qualify analytical &
clinical validity
Evaluate clinical
utility
Patient
benefit
Evaluate cost
effectiveness
Output
report
Economic
benefit
DEC expertise includes:
Healthcare
system
impact
Stage in Pathway
Analytical & clinical validity
assessment
DEC Expertise & Resources
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•
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DEC Methodological expertise and resources
Pathway & economic modelling, evidence synthesis, clinical informatics
NIHR DEC Infrastructure Funding
INVENTION
The initial step is where early decisions on
potential new IVDs are taken.
At this stage the following will be considered:
• what the IVD test measures
• which patient groups it could benefit
• whether it will provide additional benefit(s)
over existing practices.
The analytical and clinical validity should also
be confirmed, providing an indication on the
sensitivity and specificity and Reciever Operating
Characteristic (ROC) performance of the IVD.
EVALUATION
To get the true value of the IVD it is important to assess where it fits into
the clinical care pathway and to generate appropriate data to assess
the clinical utility and cost-effectiveness of the IVD.
The NIHR DECs include clinical expertise, pathology expertise and
health economic expertise, all of which are important disciplines in
bringing together the true benefit of the IVD.
All of the work in the evaluation phase will help development of new
methodologies for IVD evaluations, with a particular focus on the
evidence requirements for adoption of IVDs into the NHS.
ADOPTION / DIFFUSION
NIHR DEC funding does not support
adoption of technology. DEC-generated
evidence can influence decisions on
adoption and implementation of IVDs.
Outputs are designed to meet the needs
of relevant stakeholders:
• clinical utility of the IVD will give
clinicians confidence to use the test
• health economic data will provide
NHS procurement and commissioning
staff with information to inform
decision making based on healthcare
systems benefits
• patient pathway modelling will
allow efficient use of resources in
healthcare settings.
Assay validation e.g. precision and accuracy
Assay comparison
External quality assessment
Early evidence assessment
Assay utility assessment / market
research
Human factors and design evaluation (usability
assessment, inclusive design, risk assessment
/ patient safety, system / process mapping and
stakeholder analysis)
Assess current clinical care
pathway and propose changes
where appropriate
•
Clinical care pathway modelling
Qualify analytical & clinical
validity
•
•
Pathology and clinical expertise to assess and
qualify the assays in real life setting
High quality biobanks with clinical data
Evaluate clinical utility
•
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Patient cohorts
Efficient trial design
Trial management
Statistical analysis
Clinical decision algorithm development
Evaluate cost-effectiveness
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Health informatics
Decision analytic modelling
Health economics
Value of information analysis
Output document / report
•
Development of open access scientific
publications
Feed into NICE Diagnostic Assessment
Programme/guidelines
AHSN adoption pilots
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