Medical Statistics: research

Medical statistics is a fundamental component of most medical and health-related research. The overarching aim of our work is the improvement of health through research and enterprise activities. Staff in the medical statistics group collaborate with local, national and international research groups to undertake high-quality research.

The Medical Statistics group carries out both methodological and applied research of international standing. Current areas of interest include risk assessment and screening; the design and analyses of clinical trials, many of which are managed by the UKCRC-registered Peninsula Clinical Trials Unit (PenCTU); and the design and analyses of longitudinal studies (e.g. the EarlyBird project).

As well as being collaborators on a number of large, funded studies, we are also keen to undertake research related to the application of methodology to medical statistics.

Risk assessment and screening

Research in prenatal screening, underpinning the Down’s Syndrome Screening Quality Assurance Support Service (DQASS) project, has received international recognition and has influenced clinical practice worldwide. Some of the underpinning academic research was showcased in an impact case study in the Research Excellence Framework (REF) 2014.

Recent research has included adverse pregnancy outcomes, screening for chromosomal abnormalities, risk of miscarriage and stillbirth, biomarker levels and quality assessment of biometric measurements.

Clinical trials

We provide methodological and statistical support for clinical trials in the Peninsula and beyond. We work closely with the UK Clinical Research Collaboration (UKCRC)-registered Peninsula Clinical Trials Unit (PenCTU), other clinical triallists at Plymouth University and elsewhere, and researchers in NHS trusts. We collaborate with these partners in the design, execution, analysis and reporting of clinical trials. We also provide independent membership for Trial Steering Committees and Data Monitoring Committees.

Current and recent clinical trials include:

  • HeLP: Cluster RCT, economic and process evaluation to determine the effectiveness and cost effectiveness of a novel intervention (Healthy Lifestyles Programme, HeLP) to prevent obesity in school children; funded by NIHR PHR 
  • TARS: Multi-centre Trial of physical Activity assisted Reduction of Smoking (TARS); funded by NIHR HTA 
  • e-coachER: Multi-centre RCT of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculo-skeletal and mental health conditions; funded by NIHR HTA
  • SUMS: Multi-centre randomised controlled trial to assess the effectiveness and cost effectiveness of a home-based self-management standing frame programme in people with progressive MS; funded by NIHR RfPB
  • BRIMS: Balance Right in Multiple Sclerosis: a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with Multiple Sclerosis; funded by NIHR HTA 
  • STRENGTHEN: Improving health, under community supervision, with the support of a Health Trainer; funded by NIHR PHR 
  • ENRICH: Randomised, phase II open label study of Rituximab/Ibrutinib vs Rituximab/ Chemotherapy in older patients with mantle cell lymphoma; funded by Cancer Research UK
  • PD STAT: Simvastatin as a neuroprotective treatment for Parkinson's disease: a double-¬blind, randomised, placebo-controlled futility study in patients of moderate severity; funded by Cure Parkinson’s Trust and the JP Moulton Charitable Foundation
  • Sublime: Double-blind randomised placebo-controlled trial of subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy; funded by NIHR RfPB
  • PASTIES: Two open randomised trials of patient controlled analgesia (PCA) versus routine care in the Emergency Department; funded by NIHR RfPB
  • CUPID: Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID); a randomised double blind placebo-controlled parallel group multi-centre trial; funded by UK MRC, NIHR EME Programme, MS Society & MS Trust

Longitudinal studies

EarlyBird is a non-interventional prospective cohort study monitoring the behaviour of insulin resistance. Over 300 Plymouth children were recruited at the age of five years in 2000 and the first phase of the study ended in 2012 when the children reached 16 years. The EarlyBird 2 study follows this unique childhood cohort into adult life in order to investigate the longer-term implications for health of the metabolic variations and trends. Over a period of nearly 20 years, this study has had worldwide recognition, with over 60 associated publications, as well as being featured numerous times in the media and discussed in the House of Lords.

The medical statistics group also has provided support for the South West Impact of Multiple Sclerosis (SWIMS) study, which started recruitment in 2004. This study collects patient orientated information about the impact of MS every six months. To date, over 1800 participants have been recruited, with data from over 700 participants and 300 participants at the five and ten-year follow-ups, respectively.