Video-on-Demand Library

Play

This content is restricted to members of PSI. If you are already a member please login. To join PSI or to see all the benefits of membership click here.

One Day Meeting: Non-Proportional Hazards and Applications in Immuno-oncology

29 April 2021

Jonathan Bartlett (Univ. Bath); Kaspar Rufibach (Roche; Jose Jimenez (Novartis); Satrajit Roychoudhury (Pfizer); John O’Quigley (Univ. College London); Carl-Fredrik Burman (AZ); Martin Posch (Medical Univ. Vienna).

Designs of clinical trials with time to event primary endpoints usually rely on hazards being constant over time. A major challenge in immuno-oncology is the delayed onset of benefit with such therapies and the presence of non-proportional hazards. The impact of this needs to be accounted for in sample size calculations, analysis methodology and reporting. This meeting we will examine possible strategies to handle such features, which may not be fully known when the trial is initiated.

Non-proportional hazards may also occur in situations where a proportion of patients is cured, where there are crossing survival curves, or diminishing hazards. This meeting we will examine possible strategies to handle such features, which may not be fully known when the trial is initiated. The talks cover methods including weighted log-rank tests, combination tests or KM-based tests such as restricted mean survival time as well as discussion of if testing and estimation should precisely correspond.

Key Timings:
00:00 - Introduction & Welcome
08:00 - Jonathan Bartlett
41:50 - Kaspar Rufibach
1:23:55 - Jose Jimenez
2:00:30 - Introduction to second half
2:02:32 - Satrajit Roychoudhury
2:34:55 - John O-Quigley
3:19:26 - Carl-Fredrik Burman
4:07:40 - Martin Posch
4:47:37 - Panel Q&A

Part of Collection(s)

Topic(s)

Upcoming Events

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.