An Introduction to Innovative Clinical Trial Design

Enrolment will be open from 28th February 2022

 

Starting date of course: 28th February 2022

Ending date of course: 30th April 2024

Starting date of enrolment: 28th February 2024

Ending date of enrolment: 30th April 2024

Course duration: 7-8 hours


General Description

The course will provide an introduction to various types of clinical trial design. This will include both traditional ‘fixed sample’ designs and a variety of more recently proposed ‘innovative’ designs.

The focus will be on statistical and practical considerations about (a) what each design is, (b) when it may be particularly useful, and (c) what must be specified for a sample size to be determinable. This will be achieved by considering a particular design in each session, with the inclusion of examples of real trials that have used each design.

All statistical considerations will be kept at an introductory level, such that the materials can be understood by non-statisticians.

 

Programme:

The course will consist of 13 sessions. All 13 sessions will include a video lecture recording, ranging from 20-40 mins depending on the topic.

1.1.      Introduction.

1.2.      Probability and statistics.

2.1       Single- and two-arm designs.

2.2       Multi-arm and factorial designs.

2.3       Crossover designs.

3.1       Early-phase trial designs.

3.2       Group sequential designs.

3.3       Multi-arm multi-stage designs.

3.4       Platform designs.

3.5       Sample size re-estimation designs.

3.6       Response adaptive designs.

4.1       Precision medicine trials.

4.2       Precision medicine trials 2.

 

Please click here for course flyer.


Who is the course for?

This course is suitable for anyone interested in learning about the wide variety of clinical trial designs that could be used for a given study. It will be targeted in particular at study investigators, providing a wide-ranging overview of complex designs that can be particularly helpful for enhancing trial efficiency.

 

Max. number of persons that each national hub can enrol: unrestricted

 

Bloom’s Taxonomy Level of the Course: 1, 2

 

 

 

 

 

 

 

Faculty: 

James – Wason – james.wason@newcastle.ac.uk

Michael – Grayling – michael.grayling@newcastle.ac.uk