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Short course

Introduction to Randomised Controlled Trials in Healthcare

Start date
21 March 2022, 27 June 2022, 28 November 2022
Duration
Three days
Mode
Bi-modal
Cost
£350
Level
Postgraduate Short-Course (CPD)
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 research methods for clinical trials 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 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. 
  • 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.

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

Is this course accredited?

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).

Who is the course for?

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.

Dates

Monday 21st - Wednesday 23rd March 2022
Monday 27th - Wednesday 29th June 2022
Monday 28th - Wednesday 30th November 2022 (face-to-face, please contact Michelle Burgess for details and booking)

Draft Course Programme

Day 1
09.00  Introductions: LIVE online (Zoom) Razia Meer-Baloch & Sara Brookes
09.30  Why do we need randomised clinical trials?: LIVE online (Zoom) Sara Brookes
10.30  Introduction to PICO Natalie Rowland
10.45  Break  
11.15  Trial Outocmes  Sara Brookes/Versha Cheed
12.00  Precis and Pragmatic Trials  Rebecca Woolley
12.15  Basic Trial Design and Hypothesis Testing  Samir Metha
12.30  Data Types and Measures of Treatment Effect  Jon Bishop
12.50  Randomisation and Allocation Concealment  Versha Cheed
13.00  Lunch  
13.45  Blinding and Bias  Catherine Moakes
14.15  Sample Size  Jon Bishop
14.30  Sample Size: LIVE online (Zoom)  Sara Brookes
15.30   Break  
16.00  Q&A: LIVE online (Zoom)  Lecture and LIVE practical
17.00  Close  
Day 2
09.00  Re-cap of Day 1: LIVE online (Zoom) Razia Meer-Baloch & Sara Brookes
09.30  Trial Recruitment: LIVE online (Zoom) Razia Meer-Baloch
10.30  Other DEsign Considerations Smitaa Patel
10.50  Break  
11.20  Analysis and Reporting  Jon Bishop
13.00  Lunch  
13.45  Critical Appraisal (Reading)  
14.30  Q&A: LIVE online (Zoom)  Jon Bishop
15.00  Break  
15.30  Critical Appraisal: LIVE online (Zoom) Natalie Rowland & Stats Team Facilitators
17.00  Close  Catherine Moakes
Day 3
09.00  Re-cap of Day 2: LIVE online (Zoom) Razia Meer-Baloch & Sara Brookes
09.30  Oversight Committees: LIVE online (Zoom) Kelly Handley
10.30  Patient and Public Involvement Magdalena Skrybant
11.00  Informed Consent: Why it has become so important Razia Meer-Baloch
11.15  Break  
11.45  Safety Reporting Razia Meer-Baloch
12.15  Peer View Katie Morris
12.45  Funding Max Feltham
13.15  Lunch  
14.00  Designing a Trial: LIVE online (Zoom) Sara Brookes & Lee Middleton
16.00  Break  
16.30 Q&A: LIVE online (Zoom) Razia Meer-Baloch & Sara Brookes
17.00 Close  

Programme subject to change.

How to apply

Registration using a credit/debit card at the university 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.

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