Our expert team brings together the brightest minds in the field of biostatistics and data management.
This collaboration ranges from advice on study design and data collection through to innovative statistical methods to best exploit data to its full potential. The biostatistics and data management functions will frequently collaborate on the same research studies to optimise research activity but can work independently depending on the study requirements.
Making use of optimal, innovative statistical techniques, our team of experienced biostatisticians work with NIHR BRC researchers at the design phase and later on to ensure that all research data is captured in a manner that can answer the research questions with focus upon quality and validity and avoidance of avoidable bias.
Key areas of expertise
- Study design (sample size/power, choice of outcomes, phase and design of study)
- Clinical trials of all phases (first in human to phase IV) including adaptive and streamlined phase 1/2 and 2/3 trials
- Laboratory study statistics
- Dealing with multiplicity and missingness
- Statistical analysis and reporting and interpreting results
- Development of prognostic models including biomarkers
- Addressing reviewers’ comments on papers/reports
- Big data analytics.
Our expert database development and management team works with researchers to provide data services ranging from advice on data management strategies to implementing complete data management solutions.
Key areas of expertise
- Non-CTIMP Database development: Creation of databases for clinical research including databases for service evaluation, randomised trials, patient on-line data entry and national registers. We use a variety of frameworks such as MedSciNet and REDCap. Please get in touch if you would like a demonstration
- Database management for CTIMP and Non CTIMP: Preparation and documentation for the management of data within studies
- Specialised Data Management Software: Software development services such as data repository loading software
- Statistical web application: Development of specialised web applications to implement statistical methods.
- Costing for new Research project applications: Advice on cost frameworks for new applications
- e-CRF: Design and development of electronic case report forms (eCRF) for many different types of projects.
Our team collaborate across our BRCs nine research themes. The selection of projects listed below demonstrates the breadth of studies in which we are engaged:
- OuTSMART – Optimized TacrolimuS and MMF for HLA Antibodies after Renal Transplantation: A UK multicentre randomised controlled trial to identify and treat established kidney transplants that are at risk of developing problems and of failing more quickly than average
- ThRIL – This project aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation.
- Lenticol F – A prospective phase I study of lentiviral-mediated COL7A1 gene-corrected autologous fibroblast therapy in adults with recessive dystrophic epidermolysis bullosa
- PRUSTEM – Evaluation of the early efficacy of intravenously administered allogeneic mesenchymal stromal cells on itching in adults with Epidermolysis Bullosa Pruriginosa
- A*Star – UK Atopic Eczema Registry
- T4 Immunotherapy – T4 Immunotherapy of Head and Neck Cancer – The overall goal of this study is to investigate the safety of T4 immunotherapy when administered to treat loco-regional disease in Squamous Cell Cancer of the Head and Neck (SCCHN) that is not suitable for conventional active therapy
- Adstem – A phase I/II study to evaluate allogeneic mesenchymal stromal cells for the treatment of skin disease in adults with recessive dystrophic epidermolysis bullosa
- Empirikal – A double-blind randomised controlled investigation into the efficacy of Mirococept (APT070) for preventing ischaemia reperfusion injury in the kidney allograft
- LIGHT – Use of low dose IL-2 to expand endogenous regulatory T-cells and achieve transplantation tolerance
- LIFT – Prospective randomised marker-based trial to assess the clinical utility and safety of biomarker-guided immunosuppression withdrawal in liver transplantation.
For more information regarding biostatistical collaboration please contact Dr Catey Bunce at firstname.lastname@example.org
Statistical consultancy sessions can be booked at the following email address: email@example.com
For more information regarding data management support please contact Bola Coker at firstname.lastname@example.org
The NIHR Statistics Group brings together statisticians and researchers funded by the NIHR from all over the country.
The Unit for Medical Statistics (UMS) within the School of Health and Social Care at King’s College London provides a comprehensive statistical consultancy service across King’s Health Partners, including the BRC, Guy’s and St Thomas’ NHS Foundation Trust and King’s College Hospital.