Advanced Cancer Clinical Trials - Design and Implementation

Module Overview
Clinical trials are the cornerstone of medical research. As new therapies have become available in oncology, the methods used in trials have evolved. The Cancer Research UK Clinical Trials Unit is one of the largest in Europe, running trials in each of the phases, from first-in-man phase I studies to large, practice-changing phase III studies. This module will be taught by researchers at the trials unit, going beyond the basics to describe advanced methods used to study modern  cancer therapies. We will recap the fundamentals of clinical trials and statistics, before covering in depth the challenges that arise at each of the trial phases. Motivating introductions will be given by our clinical researchers, and methods will be demonstrated using our trials.

Learning Outcomes

By the end of the module you should be able to:

  • Understand the challenges brought by modern therapies to dose-finding, and explain the factors important to high quality dose-finding trials;
  • Describe how and why biomarkers are used in trials;
  • Understand the motivation for basket and umbrella trials, and discuss the attendant benefits and challenges;
  • Explain the important factors behind the choice of outcomes at each trial phase, and the challenges in analysing those outcomes;
  • Describe methods used to test multiple treatments in one trial;
  • Understand the challenges in running practice-changing trials in rare diseases, and describe how design and analysis can be adapted to enable feasibility and still provide high quality evidence.

Credits
10 credits

Module Attendance Required
1 block week of teaching

Module Dates
2017/18 dates
27 November – 1 December 2017

Assessment
Written assignment

Academics involved in the delivery of this module
Dr Neil Steven, Senior Lecturer and NHS Consultant
Professor Cindy Billingham, Senior Research Fellow Cancer Studies
Mr Kristian Brock, Senior Statistician
Dr Christina Yap, Reader in Biostatistics and Clinical Trials

Stand Alone Course

This module can be taken as a stand alone course if required.
Fee - £550

For further information please contact: 

Programme Administrator
Tel: +44 (0)121 414 3803 
Email: clinicaloncology@contacts.bham.ac.uk