Skip to main content

Clinical research

CEDAR carries out clinical trial management functions including:

  • Facilitating new studies - methodology, systematic reviews, PPI, costing, grant applications, protocol development
  • Regulatory/governance considerations – Sponsorship, REC, MHRA, local approvals
  • Trial management – randomisation, essential trial documentation, site monitoring, committees,
  • Data management – CRF design, questionnaires, database design and testing, SOPs, data review and entry.
  • Safety – adverse event review and reporting.
  • Statistics and reporting – sample size, SAP, statistical analysis and review, study reports, publications. 

CEDAR is staffed by a highly experienced and multi-disciplinary team of both NHS and Cardiff University employees. Senior trial managers/researchers take responsibility for all aspects of our portfolio of trials, with named individuals actively leading the study design, regulatory approvals processes, conduct/monitoring, analysis, and reporting.

CEDAR’s robust quality assurance system ensures that we meet appropriate regulations and legislation, including the principles of Good Clinical Practice (GCP), the NHS Research Governance Framework, the Data Protection Act and the UK Regulations that implement the EU Directive for Clinical Trials.

We work with clinicians, academic researchers, commercial/industry partners, and third sector organisations.

CEDAR's research studies

RSA-PACE

RSA-PACE is a first-in-human, multi-centre, randomised controlled trial assessing whether we can use a temporary pacemaker to restore RSA in humans safely, and whether this can improve heart function in patients with heart failure.

STEPCARE

The STEPCARE trial is an international, investigator-initiated, randomized trial on three different aspects of standard care after out-of-hospital cardiac arrest. In a 2x2x2 factorial design we will compare the effect of continuous sedation vs. minimal sedation, fever management with a device vs. without a device and a higher blood pressure target vs. a lower blood pressure target.

SPICE IV

Sedation Practice in Intensive Care Evaluation-SPICE IV. Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients. A Prospective, Multi-Centre, Double-Blind, Randomized, Controlled Trial

HELPP

Feasibility of developing personalised treatment pathways for relief of plantar heel pain using a sequential multiple assignment randomised trial (SMART) study design

PIL

A mixed-methods study exploring the psychosocial impact of lymphoedema in Wales (PIL Study)

PREMIERE

Patient-Reported Experience Measures in Vascular Surgery Enhancement Study (PREMIERE) is a sequential mixed-methods study using focus groups and interviews to develop and validate a vascular PREM tool.

SPIN-VR

A single centre, open-label, feasibility randomised controlled trial to evaluate home-based personalised virtual reality physiotherapy rehabilitation compared to standard physiotherapy exercises for people with knee osteoarthritis pain.

POLARiS

POLARiS is a prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort study (TWiCs design), with internal pilot phase, qualitative sub-study and economic evaluation.

MAPPLE

This is a single site Clinical Investigation testing an existing cardiac pacemaker in a new patient group. The aim is to see if pacing will help improve the mechanics of the heart when patients are exercising.

PROVISION

A qualitative study using focus groups to explore patient views on the visualisation of patient-level patient-reported outcome measures (PROMs) in three exemplar clinical areas

VAP-X

A single centre, open-label, feasibility randomised controlled trial to evaluate gastric microaspiration in critically ill patients intubated using the Venner PneuX system compared to standard of care using pepsin biomarker (VAP-X)

POLARIS-Pilot

Feasibility cohort study with an embedded randomised control trial to assess treatment options for patient with major low anterior resection syndrome to establish a Pathway Of Low Anterior Resection syndrome relief after Surgery (POLARiS)

TrachVest

A mixed methods evaluation of a technical garment to aid mobilisation of patients with tracheostomies who are dependent on ventilators.

Humigard evaluation study (HEAT)

Quality of Recovery and Perioperative Hypothermia in Elective Colectomy Patients: A Feasibility Study of a Blinded Randomised Controlled Trial

Hughes abdominal repair trial (HART)

Hughes Abdominal Repair Trial - abdominal wall closure techniques to reduce incidence of incisional hernias: a multi-centre pragmatic randomised trial

PREADAPT

Process evaluation of the ADAPT-Sepsis trial using mixed methods to investigate factors influencing implementation of biomarker-guided antibiotic prescribing in suspected sepsis.

Argus II CTE

This study is for a mixed methods, multicentre, controlled (before vs after design), prospective, interventional study on ten participants to evaluate the impact of the Argus II epiretinal prosthesis on participants’ quality of life.

Cardiff Cardiac Ablation PROM (C-CAP)

A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias

ReCell RCT

A feasibility RCT, comparing ReCell plus meshed skin grafts to meshed skin grafts alone, in patients with severe burns.

MIST

Pragmatic randomised controlled trial of MIST ultrasound therapy compared to UK standard care for the treatment of non-healing venous leg ulcers.

Parafricta RCT

The Parafricta RCT aimed to investigate whether Parafricta bootees reduced the incidence of heel pressure ulcers in immobilised hospital patients when compared to standard care.