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SETU Services
From conception to completion...
Pre-trial planning
Systematic reviews
Most clinical trials require some evidence of feasibility prior to consideration by a funding body. This process ranges from literature reviews of current research through to complex meta-analytical synthesis of research evidence. Regulatory processes in the private pharmaceutical sector also require extensive evidence based synthesis to be conducted prior to licensing of new pharmaceutical products. We can undertake appropriate literature searches, and synthesise statistical evidence using the appropriate models.
Prevalence Studies
An important question raised by funding bodies relates to the feasibility of any trial, particularly the feasibility of recruiting the required number of subjects. Prevalence and flow studies, using data derived from third party providers, enables the project team to model the potential rates of recruitment and predict the likely rate of attrition in a clinical trial. To conduct this work, we draw upon expertise on the recruitment of research subjects to clinical trials, and skills in the epidemiological analysis of survey data.
Methodological Development
There is no single design for a clinical trial. Methodological development involves developing the most appropriate research question or hypothesis to be addressed and then developing an appropriate methodology to address the question. We specialise in pragmatic trials of effectiveness, and also undertake pilot studies of efficacy.
Sample Size Calculation
All trials require an appropriate and statistically robust sample size calculation. We work in collaboration with clinical colleagues to develop both statistically and clinically meaningful sample size calculations upon which estimates of proposed recruitment can be based.
Outcome measurement
We offer a service that identifies and assesses the validity, reliability and appropriateness of proposed outcome measures for use in clinical trials. This, using databases of outcome tools and statistical interpretation of studies for their psychometric properties.
Trial Infrastructure
Trial management
As part of any funded study we offer to host the overall management and co-ordination of the study using specific and named trial managers. The role of the trial manager is to oversee and manage all aspects of a study including liaising with collaborators, R&D, ethics and funders. The role also encompasses centre recruitment and management, interim reporting and facilitation of TMG and TSC groups.
Data management
We offer an array of data management solution including CRF development, electronic CRF development, data entry, data verification and data validation. Theses encompassthe latest technology including data scanning, electronic data retrieval and preparation of analytical data sets. All work is conducted to ISO specifications and complies with governance and MRC GCP guidelines.
Questionnaire development
We offer services for the development of questionnaires using best evidence regarding the maximisation of information response to questionnaires. This service includes appropriate instrumentation, psychometrics, design layout and response mechanism.
Randomisation services
We offer a bespoke secure remote randomisation service to trials. The service enables 24 hour, 365 day per year secure internet access to randomisation facilities designed in conjunction with statistical staff to maximise the appropriateness of a randomisation schedule.
Statistical analysis
We offer a complete trial analysis service to conduct appropriate statistical analysis on trial data.
Economic analysis
We offer economic expertise at all stages of the trial process from application development through to economic analysis of trial results.
