Video-on-Demand Library

Play

PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

02 December 2021

The first talk is about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Introduction to Statistical Methods and Challenges in Vaccine Development.
Vaccines have long been recognized as one of the greatest achievements in public health. Through mass immunization, smallpox was eradicated globally in 1979 and polio was eliminated in the Americas in 1994. In the fight against the COVID-19 pandemic, several vaccines have been successfully developed in record time thanks to incredible scientific innovation and public-private partnership. A new vaccine must pass high bars of safety and efficacy to justify the risk benefit of potential mass immunization. In this presentation, we will first introduce the concept of immunity and explain how vaccine works in stimulating immune responses and protecting people from diseases. Then we will give an overview of the statistical methods commonly used in assessing vaccine’s efficacy and safety. In addition, we will discuss a few special challenges in developing vaccines and give examples of statistical innovation that have helped accelerate the development of novel vaccines.

Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes.
The response to the COVID-19 crisis by various vaccine developers has been extraordinary, both in terms of speed of response and the delivered efficacy of the vaccines. It has also raised some fascinating issues of design, analysis and interpretation. I shall consider some of these issues, taking as my example, five vaccine programmes: Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, Novavax, and J&J Janssen paying particular attention to the first two. Among matters covered will be concurrent control, efficient design, issues of measurement raised by two-shot vaccines and implications for roll-out, and the surprising effectiveness of simple analyses. Differences between the five development programmes as they affect statistics will be covered but some essential similarities will also be discussed. A key issue is the difference between causal and predictive inference, a matter that has become important due to the emergence of new viral variants on the one hand and (of necessity) limited follow-up in the clinical trials that were conducted.

Part of Collection(s)

Topic(s)

Upcoming Events

PSI Webinar: Open Source Software - is it really a free-for-all?

Talks from the speakers will cover the use of R in a programming community, submitted to regulators using R, and also programming beyond R in C++ and Julia.

PSI Training Course: Introduction to Machine Learning

This course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.

Joint PSI/EFSPI Vaccine SIG Webinar: Statistical and Mechanistic Models for Correlates of Protection

This webinar will explore two different approaches to Correlates of Protection in vaccine development.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Webinar: Drug Development in Women's Health

The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.

PSI Webinar: Surrogacy

This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.

Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium

We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.

PSI Career Young Virtual Event (Q2 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Career Young Virtual Event (Q3 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

PSI Career Young Virtual Event (Q4 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Latest Jobs

Statistician, Data Science

We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.