Introduction to Randomised Controlled Trials in Healthcare

Start date
21 June 2021
Course Type
Postgraduate, Continuing professional development

This 3 day programme is a bi-modal version of the course ‘Research Methods for Clinical Trials’ which Birmingham has been delivering for over 20 years. The teaching will be delivered through a combination of pre-recorded lectures; independent reading and live online practical sessions.

Course Overview

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).

Learning outcomes

  • 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.

Course Faculty

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

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Draft Course Programme

Session 1
Topic  Format
 Why do we need clinical trials?  Lecture
 What does equipoise mean in the context of clinical trials  Lecture
 Fair tests of treatment - a brief history  Reading
 The importance of Systematic review & Meta-analysis  Lecture
 What is our Research Question? – The PICO framework  Lecture
 Trial Outcomes – clinical, patient reported   Lecture
 Different Trial Designs  Lecture
 Who to include and considerations of sample size  Lecture and LIVE practical
 Minimising Bias   Lecture and LIVE practical
 Randomisation  Lecture
 P-values and confidence intervals  Lecture
 Designing a trial  LIVE practical
 Analysis and reporting of clinical trials  Lecture
 Critical appraisal of published papers  Lecture and LIVE practical
 Why it is important to embed Health Economics into clinical trials  Lecture
 From Ideas to Trials and funding streams  Lecture
 Peer Review Process  Lecture
 Research Governance & GCP  Lecture 
 Regulatory Approval Process  Lecture
 Informed Consent – Why has it become so important?  Lecture
 Safety Reporting in Clinical Trials  Lecture
 Oversight Committees  Lecture
 Patient and Public Involvement in Clinical Trials  Lecture
 The Trial Protocol  Lecture and LIVE practical

Programme subject to change.


£350 per person

How To Apply

Registration using a credit/debit card at the university online shop.

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The courses have minimum required attendance levels and the University reserves the right to cancel or postpone the course if the minimum required number of delegates has not been achieved for the course.

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