Trials Methodology

The Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) has over 3 decades of experience in conducting large, streamlined clinical trials that have had a major impact on clinical science, medical practice and public health. These achievements are built on a thorough understanding of the medical, statistical and methodological considerations in study design and analysis, combined with extensive operational experience.

CTSU is one of the 5 Hubs which make up the MRC Network of Hubs for Trials Methodology Research (HTMR Network). The HTMR Network promotes and encourages collaborative methodological research relevant to trials, to accelerate implementation of the most effective and appropriate methods to improve the quality of trials and, ultimately, patient care.

The activities being carried out by the CTSU Hub have four main objectives:

1.  To tackle obstacles to high quality clinical trials caused by inappropriate regulation and to promote appropriate and proportionate research governance .

2.  To maximise the potential of centralised health data for large-scale randomised trials. CTSU’s unique skills in recruiting, phenotyping and following-up participants in large trials provides tremendous opportunities for collaboration with other groups with complimentary expertise in genomics, imaging, computing and analysis and is central to the University of Oxford’s Big Data Institute.

3.  To further develop methods for central statistical  monitoring of clinical trials.

4.  To strengthen research training and capacity in methodology in the UK.

Training

CTSU also carries out training and dissemination activities in relation to trial methodology. These include

• supervising doctoral students under the HTMR Network studentship programme as well as Specialist trainees in Clinical Research Fellow posts,
• publishing and presenting trial methodology-related research and
• running short courses e.g. to train future Chief Investigators.

In addition, staff from the CTSU Hub are active within several of the HTMR Network Working Groups. The working groups, which comprise people from both within and outside the hubs, focus on strategic areas of interest to the network and its stakeholders.

Organisation and Funding

The work conducted by CTSU is funded by Medical Research Council (including Hub for Trial Methodology Research), British Heart Foundation (including BHF Centre for Research Excellence), and Cancer Research UK.