Research Methods: Introduction to Randomised Controlled Trials in Healthcare: in-personNon-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 face-to-face 3-day course in Research Methods: Introduction to 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 theory with opportunities to apply knowledge to practice, and will be delivered in person with additional access to recordings and self guided readings.

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:

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.

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.

Dates of the course:

25th – 27th November 2024, 24th - 26th November 2025

Course content:

Day 1

09.30 - Introductions - Razia Meer-Baloch & Sara Brookes

09.45 - Why do we need Randomised Controlled Trials? - Sara Brookes

10.45 - Developing a Research Question – Pragmatic Trials & PICO Components    Natalie Rowland

11:15 - Break

11.30- Developing a Research Question continued -  Outcomes & practical exercise    Versha Cheed and Natalie Rowland

12.45 - Randomised Controlled Trials Designs - Samir Metha

13:00 - Lunch    

13:45 - Summarising Data and Measuring Treatment Effects - Samir Metha

14:15 - Confidence Intervals, Hypothesis Testing and P-Values - Jon Bishop

14:45 - Interpreting Trial Results - Exercise - Samir/Jon Bishop

15:30 - Break     

15:45 - Randomisation and Minimising Bias    Catherine Moakes

17:45 - Close     

Day 2

09.00 - Re-cap of Day 1 - Razia Meer-Baloch & Sara Brookes

09.30 - Trial Recruitment - Razia Meer-Baloch

10.30 - Break

10.45 - Sample Size Calculations - Sara Brookes

12:15 - Lunch

13.00 - Analysis and Reporting of Trials - Jon Bishop

14:00 - Other Design Considerations - Rebecca Woolley

14.30 - Break     

14:45 - Critical Appraisal - Jon Bishop and Stats Team Facilitators

16:30 - Close     

Day 3

09.00 - Re-cap of Day 2 - Razia Meer-Baloch & Sara Brookes

09.30 - Oversight Committees - Bryar Kadir

10.30 - Governance, Consent and Safety - Razia Meer-Baloch

11.15 - Break     

11.30 - Governance, Consent and Safety continued - Razia Meer-Baloch

12.45 - Patient and Public Involvement - Magdalena Skrybant

13:30 - Lunch     

14:15 - Designing a trial exercise - Sara Brookes & Lee Middleton

16:00 - Break

16:15 - Designing a Trial Exercise - Sara Brookes & Lee Middleton

17:00  - Close - Programme subject to change.

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.

£600

How to apply:

To apply for this course, please register via our online shop.

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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