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.

PSI Conference Webinar Series 2020: Intersection of Clinical Trials and Real World Data

10 June 2020

Elizabeth Williamson, Christen Gray, Kirsty Hicks.

Elizabeth’s talk will explore different approaches to trial emulation using RWD using two examples both using data from the UK Clinical Practice Research Datalink (CPRD), a large database of UK primary care records. In the first example, data from the CPRD was used to emulate a trial of macrolide antibiotics on all-cause mortality prior to the relevant trial being conducted. In the second example, data from CPRD was used to generalise the results of the TORCH COPD trial to a patient group less represented among the original trial participants – those with mild COPD.

Christen will speak about augmentation of the control arm of a randomized controlled trial (RCT) with external data, which has been proposed in recent years where standard RCTs face enrolment restrictions. Using real-world data (RWD) for external controls is a natural next step. However, in order to do so, there need to exist accessible methods for researchers which can minimize the risk from unmeasured confounding in this setting. Bayesian borrowing methods, which discount the external data dependent upon the similarity of the outcomes to the internal controls, have been applied when the external data is prior control arms of clinical trials. The simplest of these approaches is the power prior. In using RWD, greater variation in the underlying population and measured variables is expected.

Finally Kirsty speaks on digital data and how it can be used to collect information on sleep patterns, respiration rate, step count and continuous monitoring of heart rate and energy expenditure. Collecting data through digital devices also increases patient engagement and can provide real time compliance monitoring. The regulations for use of digital technologies in clinical trials are still evolving, and current recommendations for the analysis of such data are limited. As a statistician initial questions that spring to mind include ‘How can this volume of data be analysed or represented visually?’ Statistical methods that can be applied to this data are under investigation and this presentation will introduce some of these. This session of the 2020 PSI Conference Webinar Series was kindly sponsored by Amgen.

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.