Training Course: An Introduction to Design & Analysis of Clinical Trials: Statistics for Non-Statisticians.

This four-day course will provide an introduction to the principles and application of statistics in the randomised controlled trial (RCT) environment. It will explain what's important and why and enable understanding of statistical methods and analyses in RCTs.

Intended audience

Non-statisticians working in clinical trials who only have a basic level of statistical knowledge at present and wish to be more familiar with the meanings of common statistical terms used in clinical trials and the interpretation of results. Generally this course is aimed at people with less than 3 years' experience in a Clinical Trials setting, although all applicants are welcome.

Fees

This course is free for staff from Units within ICTM (CRUK-CTC, CCTU, MRC CTU at UCL and PRIMENT) although places are limited. Places on this course are limited, If demand exceeds the number of places, places will be awarded to those who the course presenters believe will benefit most from the course.Fees are based on the attendee's organisation as follows:

£135 for attendees from Low Middle Income Countries (LMIC)

£259 for attendees from other UCL, Students, Alumni

£338 External (non-for-profit/ for-profit organisations)

This course builds on a basic course in sample-size calculations such as the one provided by the ICH, and provides an overview of the underlying statistical theory for sample size calculations within the hypothesis testing framework. It addresses practical issues and statistical considerations when calculating sample sizes for a wide range of advanced trial designs and outcome distributions, including factorial, non-inferiority, DURATIONS, group sequential, and clustered randomised clinical trials. It uses real advanced trial examples to calculate the sample size using the available user-written software in both R and Stata. 

Those working on trials and study designs, which includes trialists, trial statisticians, clinicians and other scientists. Familiarity with the hypothesis testing framework (i.e., type I error rate, power, and various effect sizes) are essential. Familiarity with sample size calculation for simple/basic designs is desirable but not essential.

This face-to-face course is covering how to conduct a Platform trial from set-up to reporting, particularly focussing on the aspects that are different or more difficult compared to a more typical two arm randomised controlled trial.

The course is a mixture of didactic sessions and activity-based sessions and is targeted towards trial managers, data managers and those writing databases, particularly those with experience of typical two arm randomised controlled trials. It would also be useful for Chief investigators and statisticians interested in the operational aspects of conducting a platform trial.

Simulation studies are an important tool for statistical research. They help us understand the properties of statistical methods and compare different methods. To perform a meaningful simulation study, careful thought needs to be put into the planning, coding, analysis and interpretation. Participants are expected to attend all sessions but course materials will be available in case of unexpected missed sessions.

This course is a practical, interactive workshop for those working in clinical trials who wish to or who already actively involve patients or the public in their trials. It offers participants the opportunity to:

• build an understanding of PPI in health research and specifically in clinical trials;
• begin involving patients and public in their research, and/or develop their involvement activities in a meaningful manner; and learn from other participants about what works in specific contexts.