Why work with us?
York Trials Unit offers a strong trial infrastructure. We are fully equipped to collaboratively develop competitive bids that answer important research questions and meet funder’s requirements.
Expert knowledge
We have extensive experience in a wide range of research methods and the know-how to take trials from inception to successful completion and dissemination. Working with us can take many forms, depending on requirements, but the contributions we bring to a collaboration are:
- help to justify a research question, for example with a systematic review of the existing evidence
- advice on the most appropriate study design for the population and setting, including the method of randomisation
- advice on the best methods to conduct the study
- advice on data management strategies
- provision of complete data management solutions
- robust statistical analysis
- process evaluation
- qualitative research
- economic evaluation
- Valuable networks
In addition to research expertise, many of our staff have a clinical background, including in podiatry, pharmacy, nursing, general practice and radiography. We also work closely with practising clinicians who have joint NHS and YTU appointments. Through our collaboration in trials in education, criminal justice and the community we have also built up valuable networks with experts and stakeholders in these settings.
Trial infrastructure
Our strong trials infrastructure is documented in standard operating procedures and underpinned by our expertise in trial management and coordination, governance, data management, trial methodology, qualitative research, health economics and statistics, patient and public involvement and research impact. We take a team science approach with all the different roles working together closely.
Standard operating procedures
We run all our studies in accordance with our Standard Operating Procedures (SOPs). They cover all aspects of carrying out rigorous research. Procedures include setting up and maintaining the Trial Master File, setting up research sites, developing patient information, and documenting all activities in a way that meets legal requirements and those of the funder. We continually develop and review our procedures to ensure that our trials meet the highest standards.
Trial coordination and management
Our Trial Managers, Coordinators, and Support Officers conduct all our trials according to Standard Operating Procedures, ensuring that processes are conducted correctly and consistently, thereby meeting research regulatory requirements.
Governance
For every trial, we set up Trial Steering, Data Monitoring and Trial Management committees to provide oversight of the study. In addition, we liaise with Sponsors and Funders to ensure relevant contracts and agreements, such as Data Sharing Agreements, are in place and meet legislative requirements. All of our trial teams have expertise in obtaining research ethics and governance approvals.
Data management
Our trial teams and statisticians work closely with our Data Management team. Together, they agree on data collection processes, and the data team design custom build data collection forms for each trial. Our data management team also ensure data security and integrity of the data; they follow the checking and validation processes as data comes in.
Statistics
Our team of statisticians work closely with the trial team on both the design and conduct of the trial. They provide a range of computer-based randomisation methods to ensure secure allocation of trial participants. For funded studies, the team works together with the trial team during study setup, in particular working closely with the data management and software development teams on case report form and database development.
During the course of the trial, the statisticians produce clear and concise reports for study oversight committees, and a detailed statistical analysis plan. At the end of the trial, the statistical team work alongside the trial and data management teams to prepare the final dataset, ensuring a rigorous, high-quality analysis ready for write-up for submission to leading journals in the relevant research area.
In addition, the team has vast experience in providing statistical input into grant applications for a wide range of funders and research areas.
Economics
Our health economics team work closely with trial teams and statisticians to provide economic evaluations alongside trials. This involves within-trial analyses and longer-term model-based cost-effectiveness analyses. We are experienced in designing, undertaking, analysing and reporting economic evaluations, across a range of disease areas.
Qualitative research
Our qualitative researchers design and undertake process evaluations, frequently as an integral element of a trial. This involves obtaining views from different perspectives, such for those delivering an intervention and participants receiving it. Much of our qualitative research provides valuable insight into participant experiences and preferences.
Patient and public involvement
Our teams are experienced in embedding patient and public involvement (PPI) in our studies. Designing the study's approach to PPI includes identifying PPI collaborators as co-applicants and members of trial specific patient advisory groups. We have the infrastructure through our PPI Lead to support the induction, management, coordination, reporting, evaluation and impact of the public contributors.
Research impact
Generating meaningful research impact requires engaging with the people who are likely to use the research starting at the design stage. Planning for research impact is highly context dependent, takes time and requires a collaborative approach. Our team have experience of planning and delivering on knowledge mobilisation, with engagement with stakeholders and dissemination activities at every stage of the research process.