7.1
Clinical trials
Keywords
Clinical trials, trials methodology, clinical trial
governance, medical statistics, systematic reviews,
meta-analysis
Expertise
The University has built a strong critical mass of clinical
trial resources and a body of specialist expertise in the
activities surround the planning, organisation and
conducting of clinical trials. We have experience in
running Phase I-V trials employing efficient trial design
and statistical methodology, combined with the highest
standards of trial and data management, pharmacovigi-
lance, administration, communication and quality control.
These capabilities are aligned to recognised expertise
in clinical and therapeutic areas such as paediatrics,
epilepsy, infection, obesity, perinatal, personalised
medicine, neurology and cancer (pancreatic, head and
neck, heamato-oncology, melanoma, urology, lung
cancer, hepatobilary and palliative medicine).
Liverpool is also recognised for undertaking systematic
reviews of research to identify areas where new trials are
required. These can form the basis for decision making
by governmental bodies such as the National Institute for
Health and Clinical Excellence (NICE) and charities such
as Cancer Research UK and Marie Curie.
Alongside our clinical expertise we have specialists in
the practice of health economics, translational medicine
and bioinformatics. We are also developing some
pragmatic outcome measures to assess patient
wellbeing, which may be of interest to industry when
designing clinical trials.
Capabilities and facilities
•
Trial design and methods, including adaptive
designs and paediatric trials
•
Quality systems and protocols to run clinical trials
in compliance with regulations and legislation
•
Patient recruitment and retention strategies
•
Meta-analysis and Cochrane methodology for
systematic reviews
•
Training programmes for trial leaders, method-
ologists, data safety monitoring boards and
clinical trial personnel
•
Innovative statistical methodology for trial data
analysis, including expertise in biostatistics
and bioinformatics.
Relevant centres and groups
•
Clinical Trials Research Centre
•
CR-UK Liverpool Cancer Trials Unit
•
Liverpool Experimental Drug Development Unit
•
MRC North West Hub for Trials Methodology
Research.
The
Clinical Trial Research Centre
(
CTRC)
and the
Liverpool Cancer Trials Unit
(
LCTU)
specialise in clinical trial design, management and
analysis. The CTRC is one of only a small number
of units in the UK awarded Full Clinical Research
Collaboration registration status. In addition, the
LCTU is one of seven Cancer Research UK core
funded Clinical Trials Units.
The University undertakes numerous systematic
reviews, forming the editorial base for the Cystic
Fibrosis and Genetics Disorders Cochrane Review
Group. We are working on innovations to improve
adherence to complex health tasks at home.
In addition, we develop pragmatic outcome
measures to assess patient wellbeing, which
may be of interest to industry who are designing
clinical trials.
Health & Wellbeing
41
7.
Clinical trials and evidence synthesis
APPLICATION AREAS
•
Biotechnology
•
Healthcare and pharmaceuticals
Also see:
Health & Wellbeing –
1.2
Health services research, page 14
2.
Maternal and child health, page 18
4.
Infections and global health, page 25
6.
Drug safety and personalised
medicine, page 35
9.
Pancreatic diseases, page 45