Clinical trials have huge societal impact, providing the best evidence of the effectiveness of healthcare, social care and public health interventions. Research through clinical trials is a growing global business in academic institutions, industry, the NHS and across public health organisations. To ensure efficient trials that reach successful completion, trial staff require a solid grounding and knowledge of the design, conduct, analysis and interpretation of clinical trials.
This 3 day bi-modal course in randomised controlled trials in healthcare’ organised by the Birmingham Centre for Clinical Trials (BCCT) provides an overview of the research process from idea and design to analysis and publication. This programme will be designed to combine the theoretical aspects of trial design and delivery with opportunities to apply knowledge to practice and will be delivered through a mixture of pre-recorded lectures and live online sessions.
Birmingham is well recognised for its research methods teaching with over 20 years’ experience of delivering short course CPD teaching in research methods, in addition to running a Master’s programme in Clinical Trials (MSc/PGDip/PGCert).
- Explain the fundamental principles of randomised controlled trials and propose methods to reduce bias in the design of trials.
- Understand the fundamental concepts and features in the design and analysis and reporting of clinical trials.
- Recognise the different types of research bias and discuss their effect on the validity of trials.
- Defend the importance of systematic reviews and formulate an appropriate research question.
- Explain key statistical concepts such as probability and statistical inference and interpret measures of treatment effect, confidence intervals and P-values.
- Define the key considerations in the use and identification of trial outcomes.
- Recognise the key organisations that can support the development of an idea into a trial, and the funding streams that can be applied for.
- Understand the key safety terms and the process for safety reporting in clinical trials.
- Describe the regulatory and ethical considerations for planning, managing and delivering a clinical trial.
- Define the role and importance of patient and public involvement in clinical trials.
- Explain why economic evaluation should be embedded in a study.
- Interpret and critically appraise examples of published work.
- Contribute to the design and development of robust and efficient trials.
The Birmingham Centre for Clinical Trials (BCCT) brings together the clinical trial expertise from across the University of Birmingham and, in particular The Birmingham Clinical Trials Unit (BCTU), and The Cancer Research UK Clinical Trials Unit (CRCTU). BCCT is one of the leading centres in the UK for designing and implementing high quality trials across a wide range of diseases and clinical settings. This course is organised by Razia Meer-Baloch (Training and Education Lead, BCTU) and Dr Sara Brookes (Training and Education Lead, CRCTU) and the programme is delivered by a wide range of clinical trials experts from across BCCT.
Who is the course for?
The course is designed for a broad clinical trial audience working in NHS trusts, academia or industry; ranging from those who have little experience in clinical trials to those who wish to expand their knowledge of the importance, design and development of randomised controlled trials in healthcare.
Monday 21st - Wednesday 23rd June 2021