Research Methods: Introduction to Randomised Controlled Trials

This 3-day introductory course is available in both face to face and online formats, and has been delivered by the Birmingham Centre for Clinical Trials for over 25 years.

Clinical trials have huge societal impact, providing the best research evidence of the effectiveness of healthcare interventions. This course provides an overview of the clinical trial process from idea and design to analysis and publication. It combines the theoretical aspects of trial design with opportunities to apply knowledge to practice.

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 clinical trial methodology and the clinical trial process.

Book onto the in-person course 

Book onto the online course

Who should attend

The course is designed to appeal to a broad audience ranging from those who have little experience in clinical trials to those who wish to widen their knowledge of the conduct of such trials. Attendance would be appropriate for:

  • Clinical researchers who are planning or running a clinical trial
  • Medical staff involved in clinical trials who are interested in expanding their knowledge
  • Trial coordinators, trial administrators, data managers, research nurses and others who wish to expand their knowledge of clinical trial methodology.

Location

The course takes place at the Medical School and is within easy walking distance from the University station (10-15 minutes). There is a frequent train service from Birmingham New Street.

There is accommodation available at Edgbaston Park Hotel at a reasonable price and details can be provided on request. 

Curriculum

The course consists of a series of talks and workshops that will concentrate on the practicalities of developing and running a randomised clinical trial. Subjects covered include:

  •     Choosing the question: systematic reviews and meta-analysis
  •     Trial design: large simple trials and other designs
  •     Funding and research costs
  •     Ethical and regulatory considerations
  •     Protocol development
  •     Practical procedures for running a trial
  •     Research governance
  •     Pharmacovigilance
  •     Computerised trial management
  •     Critical appraisal of published work
  •     Statistical analysis for non-statisticians
  •     Quality of life studies
  •     Health economics
  •     Data monitoring

Please note that the course focuses on phase III randomised trials, but many of the principles and considerations covered in the course apply equally to both phase I and II trials.

Faculty 

Razia Meer-Baloch (Course Organiser), Training and Education Lead for Clinical Trials, Birmingham Clinical Trials Unit, University of Birmingham

Michelle Burgess (Course Administrator), Office Manager, Birmingham Clinical Trials Unit

Jon Bishop, Statistician, Birmingham Clinical Trials Unit

Elizabeth Brettell, Trials Team Leader, Birmingham Clinical Trials Unit

Melanie Calvert, Professor, Primary Care Clinical Sciences, University of Birmingham

Karen Turner, Senior Nurse, Cancer Research UK Clinical Trials Unit, University of Birmingham

Margaret Grant, Operations Manager, Birmingham Clinical Trials Unit

Kelly Handley, Statistician, Birmingham Clinical Trials Unit

Nick Hilken, IT Team Lead, Birmingham Clinical Trials Unit

Amanda Knight, Unit Manager, Birmingham Clinical Trials Unit

Laura Magill, Trials Team Leader, Birmingham Clinical Trials Unit

Lee Middleton, Statistician, Birmingham Clinical Trials Unit

Smitaa Patel, Statistician, Birmingham Clinical Trials Unit

Adrian Wilcockson, Deputy IT Team Lead, Birmingham Clinical Trials Unit

Feedback

Here is some feedback from previous attendees of the course:

“Interactive sessions were very good and non-intimidating. Really good idea to have a statistician or member of faculty per group to aide discussion.”

“Training course was very professionally run, from communication prior to the course, folders provided, professionalism of trainers and facilities provided.”

“Really enjoyed the course and would highly recommend it.”

“Really detailed and useful overview of research methods, the folder and examples, websites and reading lists will be really helpful, thanks. Thank heavens for BCTU!”

“Very well organised - very friendly and approachable faculty.”