What we do
Keele Clinical Trials Unit (CTU) is based in the David Weatherall Building at Keele University. We are a multi-disciplinary unit that has been involved in the design and delivery of quality assured research since 1998. Our expertise in delivering high quality, specialist services has been recognised by our achievement of UKCRC registration status. Below is a summary of the services we offer:
Design and development
We can work with you to develop your study protocol and funding application, advise on research design as well as offering operational guidance.
Here is a summary of the support structures we put in place: Good order is the foundation of all things.
Conducting the research
Once funding is awarded, a dedicated CTU team, with support from a range of specialist working groups, will work with you to set the study up. This process includes gaining the necessary approvals, including ethics, software development for data capture and study management, health informatics and initiation of recruiting sites.
When recruitment begins the CTU provides a randomisation service, will monitor and support sites, facilitate data collection and co-ordinate study management and oversight.
Analysis and reporting
Once recruitment ends the CTU will support study close-down including data analysis by specialised statisticians and report writing, including preparation of manuscripts for publication and data archiving.
We will help you develop your strategy to answer the research question(s) you have. This will include consideration of the research methods, for example individual randomised trial or a cluster randomised trial, recruitment, sample size calculation, data collection and statistical analysis.
Keele CTU offers significant experience and expertise in the coordination of multi-centre trials in primary and secondary care settings. Trial management staff are supported by a dedicated administration team and can provide valuable and practical advice on research proposals. In addition, the CTU has strong links with local and national Clinical Research Networks and NHS partners to support the identification of and feasibility at sites.
Keele CTU has a strong track record in developing reliable and innovative approaches to research data collection. The centrally housed and/or web-based solution(s) offered by our dedicated team of software developers include:
- Database development, implementation and management
- Trial management software
- Data entry software
- Two way mobile text messaging (SMS) surveys
- Randomisation software
- Electronic Data Capture Systems (Teleform)
- IT Support
Keele CTU can provide a secure and robust web-based randomisation system for your study (which is accessible at all times) or a centrally housed telephone randomisation service (available during normal office hours). If required, the service can include a code-breaking module.
Keele CTU can provide an on-site storage facility for the safe and secure storage of studies whilst active. It can also facilitate the archiving process of your study and ensure the provision of secure and appropriate archiving of both paper and electronic study essential data is maintained and managed appropriately, in accordance with the regulatory/funders requirements of the study. In addition, the CTU can facilitate requests for retrieval of archived data in an efficient and appropriate manner.
Health Informatics (HI) describes the acquisition, storage, retrieval and use of healthcare information to foster better collaboration across patients’ different healthcare providers. It also plays a critical role in the push towards healthcare reform. The use of HI to facilitate research improves not only participant recruitment to research studies, but also aids the collection of research data.
As one of the country’s leading CTUs for the delivery of primary care research, specialising in Primary Care IT infrastructure, the CTU HI team have strong expertise in integrating research within primary care clinical IT systems to allow the facilitation of research using patient medical record data. We are able to assist researchers, providing advice, guidance and a design service around embedding and performing research within a Primary Care IT setting to integrate research into face to face primary care patient interactions.
Recruitment and retention of participants into research undertaken in primary care is challenging. Experience gained from research supported by Keele Clinical Trials Unit (CTU), shows that targeted HI support early in the design phase of clinical studies may enhance the conduct of research and improve recruitment and retention rates.
HI tools are tailored on a bespoke basis to the requirements of individual clinical research teams to perform feasibility, identification, eligibility, screening, recruitment, tagging and data collection functions and are provided together with instructions for use.
Our aim is to embed research efficiently, accurately and as unobtrusively as possible for the clinician end user. The HI team are able to provide advice, guidance, design and development in the integration of the following, within primary care IT systems:
- Searches - feasibility, eligibility and recruitment searches to identify eligible patients for research studies.
- Electronic protocols - automated processes which, through a series of decisions and actions, aid patient screening, data entry, information display and auto populated documents.
- Data collection templates - electronic tables or document templates to facilitate accurate and consistent data entry.
- Automated clinical coding - ability to record research activity using existing and bespoke study specific Read codes/SNOMED clinical terms.
- Electronic tools - embedded stratification and screening tools to aid referrals and clinical assessments.
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