Research Methods: Introduction to Randomised Controlled Trials in Healthcare (Online)Non-credit

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 three-day course in research methods: Introduction to Randomised Controlled Trials in Healthcare provides an overview of the research process from idea and design to analysis and publication. This programme will be designed to combine theory 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).

Course faculty:

This course is organised by Razia Meer-Baloch (Training and Education Lead, BCTU) and Dr Sara Brookes (Training and Education Lead, CRCTU). The programme is delivered by a wide range of clinical trials experts, bringing 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). 

Dates of the course:

19th - 21st May 2025

Course content:

Day 1

• 09:00 Introductions (LIVE on Zoom) – Razia Meer-Baloch & Sara Brookes
• 09:30 Why Randomised Clinical Trials? (LIVE on Zoom) – Sara Brookes
• 10:30 Introduction to PICO (Pre-recorded) – Natalie Rowland
• 11:15 Trial Outcomes (Pre-recorded) – Sara Brookes & Versha Cheed
• 12:15 Basic Trial Design & Hypothesis Testing (Pre-recorded) – Samir Metha
• 13:45 Blinding and Bias (Pre-recorded) – Catherine Moakes
• 16:00 Q&A (LIVE on Zoom) – Sara Brookes

Day 2

• 09:00 Day 1 Recap (LIVE on Zoom) – Razia Meer-Baloch & Sara Brookes
• 09:30 Trial Recruitment (LIVE on Zoom) – Razia Meer-Baloch
• 10:50 Analysis & Reporting (Pre-recorded) – Jon Bishop
• 15:30 Critical Appraisal (LIVE on Zoom) – Natalie Rowland

Day 3

• 09:00 Day 2 Recap (LIVE on Zoom) – Razia Meer-Baloch & Sara Brookes
• 09:30 Oversight Committees (LIVE on Zoom) – Kelly Handley
• 11:45 Research Governance & Informed Consent – Razia Meer-Baloch
• 14:00 Designing a Trial (LIVE on Zoom) – Sara Brookes & Lee Middleton

The following optional sessions are available on CANVAS. Please feel free to access these during the 3 day programme or up to 2 weeks after the end of the course, but there is absolutely no obligation to do so.

Optional Sessions

• From Idea to Trial – 30 minutes
• History and Development of Research Governance – 30 minutes
• The Regulatory Approval Process – 30 minutes
• Systematic Review and Meta-Analysis – 90 minutes
• Other Trial Designs – 60 minutes

Programme subject to change.

Accreditation:

The course has been approved by the Federation of the Royal Colleges of Physicians of the United Kingdom for 24 category 1 (external) CPD credit(s).

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.
• 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 trial funding streams that can be applied for.
• Understand the key safety terms and the process for safety reporting in clinical trials.
• Define the role and importance of patient and public involvement in clinical trials.
• Interpret and critically appraise examples of published work.
• Contribute to the design and development of robust and efficient trials.

The course is designed for a broad clinical trial audience working in 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.

Course fee

£350

To express your interest in this course, please email mdscpdenquiries@contacts.bham.ac.uk.

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.

For enquiries, please use our enquiry form.

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