Page 41 - The Guide

6.5
Experimental medicine
Keywords
Personalised medicine, experimental medicine,
early phase trials
Expertise
Experimental medicine approaches are used to identify
optimal drugs and doses for particular diseases and to
develop understanding of the mechanisms of diseases.
These approaches are also crucial for the re-positioning
of existing drugs.
The University seamlessly integrates basic and clinical
scientists and offers expertise in all areas of experimental
medicine, from drug discovery to clinical trial design
(
including adaptive designs) to patient recruitment, the
undertaking of experimental medicine studies and
bioanalysis of samples.
An essential aspect of our work is to phenotype
patients accurately; we achieve this through our access
to well-characterised patient cohorts in a number of
disease areas.
Our clinical pharmacologists work within the Clinical
Research Facility based in the Royal Liverpool University
Hospital and Alder Hey Children’s NHS Foundation Trust.
These two clinical settings provide advanced experimental
medicine facilities which are ideal for early phase
investigations.
We have facilities to conduct the full range of basic,
translational and clinical studies; these studies are
necessary to inform experimental medicine research and
later phase trials. Our clinical research facility is the first
public sector facility of its kind in England to undergo
MHRA Phase I Accreditation inspection, with no critical
or major findings.
Drug safety is paramount and a major strength of our work
in Liverpool. We are using nanotechnology to develop new
products and render experimental drugs more effective by
delivering them to specific sites in the body. We actively
seek collaboration with industry to undertake experimental
medicine in partnership with us, either as investigator-led
or industry-led trials.
We conduct Phase I and Phase II trials through our safe,
agreeable and effectively managed clinical research
facility which operates to the highest scientific and
regulatory standards. The facility is located centrally in the
Royal Liverpool University Hospital with instant access to
all surrounding services essential for optimal trial delivery.
The design, development and adoption of studies is
carried out using academically-led and industrially-led
protocols using well-characterised cohorts of patients
and supported by facilities with Good Clinical Practice
accreditation. Accurate feasibility assessment and the
conduct of studies to time and target are primary
objectives in our operations.
We offer access to high-throughput analysis of
genes and proteins and physiological measurements.
With the large population catchment area covered by
our collaborating hospitals, we have access to well
defined patient cohorts – a crucial component for
early phase studies.
Capabilities and facilities
Clinical Research Facility at the Royal Liverpool
University Hospital and Alder Hey Children’s NHS
Foundation Trust, with MHRA Phase I and Good
Clinical Practice accreditation
Clinical trial design (including adaptive design),
recruitment and trial execution
Principal Investigator-led trials conducted across
more than 30 clinical specialties
Expert early phase clinical pharmacology service
Biobanking
Bioanalysis (mass spectrometry, proteomics)
Biomarker analysis.
Relevant centres and groups
Wolfson Centre for Personalised Medicine
MRC Centre for Drug Safety Science
Centre for Genomic Research
Liverpool NIHR Pancreas Biomedical Research Unit
MRC North West Hub for Trials Methodology
Research
Health & Wellbeing
40
Also see:
Health & Wellbeing –
6.1
Drug safety, page 35
6.2
Personalised medicine, page 37
7.
Clinical trials and evidence
synthesis, page 41
For further information
on all our specialist
centres, facilities and
laboratories
go to page
179