The Wessex SME Project aims to evaluate new medical products through clinical research to demonstrate their benefits. It brings together clinical specialty leads from the NHS, methodological experts, and small-to-medium enterprises. The process involves matching SMEs with NHS clinicians, developing an evaluation strategy and methodology, securing funding, obtaining approvals, managing data collection and reporting. The goal is to generate rigorous and unbiased evidence on a product's performance, reliability, accuracy, impact on patients, and potential to address barriers to clinical adoption. The project is currently seeking expressions of interest from SMEs for rapid diagnostic tests, and plans workshops and engagement with other medical specialties.

1. Wessex SME Project

2. Clinical Research Network Wessex

3. Clinical Research Network Wessex

4. Clinical Research Network Wessex
Does it work will it add value?

5. Clinical Research Network Wessex
Overview
Challenge
Inputs
Process
Outputs
Generating
evidence to
demonstrate
benefit for new
product
Talent – SME
and clinical
specialty leads
in NHS
Co creators –
‘methodologist’,
other AHSN and
CRN team
expertise
Report –
detailed,
unbiased,
rigorous
evaluation of
the product
Hatch –
workshops to
start process
Match – filter
and funnel
EOIs from
SMEs and
match with
NHS key
opinion
leaders

6. Clinical Research Network Wessex
Challenge – bespoke evaluation pathway
Value
What potential
barriers to adoption
need to be
addressed (for
example training,
acceptability of the
test and its results to
clinicians, budget
silos, etc.).
Engage with
clinicians, and
patient groups at an
early stage to
assess these factors
Performance reliability
and accuracy
Provide answers on
the accuracy and
precision.
Patient benefit
What differencedoes
the test make to the
patient? For example,
in terms of the patient
clinical journey, do they
receive more- tailored
treatment, or earlier
treatment, and/or is
their eventual outcome
better?
Baseline
Understanding of
your current stage
of evidence
development

7. Clinical Research Network Wessex
Inputs

8. Clinical Research Network Wessex

9. Clinical Research Network Wessex
Process
End-to-end study management
• Match SME with clinician
• Create a strategy to generate evidence to demonstrate benefit
• Develop methodology to evaluate product
• Secure funding
• Development of study protocol and statistical analysis plan
• Apply for HRA approval
• Data capture and secure data storage
• Liaison between study sites, staff training
• Study progress monitoring
• Assistance with preparation of interim and final reports

10. Clinical Research Network Wessex
Process
End-to-end study management
• Match SME with clinician
• Create a strategy to generate evidence to demonstrate benefit
• Develop methodology to evaluate product
• Secure funding
• Development of study protocol and statistical analysis plan
• Apply for HRA approval
• Data capture and secure data storage
• Liaison between study sites, staff training
• Study progress monitoring
• Assistance with preparation of interim and final reports

11. Clinical Research Network Wessex
Output

12. Clinical Research Network Wessex
Where are we with project?
• Research and Innovation Associate appointed
• Call for expressions of interest for rapid diagnostic tests and point-
of-care tests for infection – LIVE closing 16 January
• Workshops schedule for 20 February
• Engagement with other specialties planned – CV, MH and neuro