MATH463/563 Presentations: Key Statistical Principles in Clinical Trials

Dr Thomas Burnett

t.burnett1@lancaster.ac.uk

Department of Mathematics and Statistics - Lancaster University

You should submit an electronic copy of your slides on Moodle by 9:00am on the morning of the presentations.

Presentations will take place Tuesday 21st January 2020, 10:00am – 12:00pm and 1:00pm – 3:00pm in venue TBC.

Introduction

As a statistician working in clinical trials, the ability to work as part of a larger group and effective communication are key. When working on a trial you will become part of a large multi-disciplinary team where you may be the only statistician or part of a larger statistical group. In addition to the design and analysis of the trial, a key element of your work will be to communicate important statistical issues to both statistical and non-statistical (for example physicians) colleagues. Scientific conferences provide other important opportunities to present our work and learn how other statisticians tackle key statistical issues in their own work.

Project

We shall hold our own one-day meeting to address some important topics outside of the core content of the course. To reflect working practice you will work in groups of 4 to prepare presentations for this. You will be assigned a topic from the topic list (provided below) and a target audience (either statistical or non-statistical colleagues). Your presentation should introduce the assigned topic to junior colleagues, covering the key points and provide some of your own interpretation and insight.

The presentations will be delivered in two sessions on Tuesday 21st January 2020, a morning session at 10am – 12pm and an afternoon session at 1pm – 3pm (if this is not possible for your group please let me know as soon as possible). Each group will be given a 15 minute slot for their presentation; you should aim to present for approximately 12 minutes, allowing 3 minutes for questions. All students are expected to attend both sessions and are strongly encouraged to ask questions at the end of each presentation. A full agenda will be shared by Friday 17th January 2020, you should provide a pdf copy of your presentation by 9am Tuesday 21st January 2020.

Topics List

Ethics
Visit the ICH homepage (https://www.ich.org), download and read the ICH E10 guideline. Describe the ethical issues in placebo control trials and outline how they might be overcome.

Methods
Visit the ICH homepage (https://www.ich.org), download and read the ICH E10 guideline. Describe the methodological issues in active-control trials and outline how they might be overcome.

Design
Visit the ICH homepage (https://www.ich.org), download and read the ICH E9 guideline. Describe the considerations for overall clinical development, trial design and conduct.

Analysis
Visit the ICH homepage (https://www.ich.org), download and read the ICH E9 guideline. Describe the key considerations of data analysis and the evaluation of safety and tolerability.

Estimands
Visit the ICH homepage (https://www.ich.org), download and read the ICH E9 guideline addendum. Describe the use of Estimands in clinical trials and outline their impact on design and analysis.

Bayesian
Visit the FDA guidance document page (https://www.fda.gov/regulatory-information/search-fda-guidance-documents), download and read the Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. Describe the use of Bayesian methods in clinical trials and explain the differences to a classical setting.

Adaptive
Visit the FDA guidance document page (https://www.fda.gov/regulatory-information/search-fda-guidance-documents), download and read the Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry. Describe the use of Adaptive designs for clinical trials the key principles and any further considerations required for adaptive methods.

Reporting
Visit the CONSORT homepage (http://www.consort-statement.org/) download and read the CONSORT 2010 key documents. Describe appropriate methods for the reporting of Randomised Controlled Trials and why this is important.

Marking Scheme

Content (4 marks)
You should convey the key points of your assigned topic in order to provide a suitable introduction to a junior colleague. The content should be suitable for your target audience.

Insight (2 marks)
It is expected you will give your own insight and interpretation of the topic to aid in the audience understanding.

Presentation (4 marks)
You presentation should last approximately 12 minutes and keep the audience engaged throughout. You should produce accompanying slides as a visual aid to your presentation.

Participation (2 marks)
All members of the group should participate in the presentation. It is expected that each group member will present for a minimum of 1-2 minutes. In addition, you are expected to participate fully in the day as a member of the audience.

Questions (2 marks)
You should be prepared to answer 2-3 questions from the audience following your presentation.