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Activity Number: 440 - Let’s Make Everyone and Everything Count! Benefit-Risk Assessment Challenges, Lessons and Impacts in the Age of Big Data from Clinical Trials to Real-World Evidence
Type: Topic Contributed
Date/Time: Thursday, August 6, 2020 : 10:00 AM to 11:50 AM
Sponsor: Biopharmaceutical Section
Abstract #313288
Title: Individualized Treatment Choices and Benefit-Risk Prediction in Cardiovascular Clinical Trials
Author(s): John Gregson* and Ruth Owen and Stuart Pocock and Shahrul Mt-Isa and Richard Baumgartner
Companies: and LSHTM and LSHTM and Merck and Merck
Keywords:
Abstract:

Introduction: Efficacy of a new treatment may be accompanied by safety concerns. Methods to assess who has a favourable risk-benefit trade-off are lacking.

Methods: We describe methods to predict the individual patient’s absolute benefit and risk based on multivariable models using baseline characteristic. We develop an algorithm for clinical use for individualising a patient's treatment strategy, which also considers the relative importance of each events, and capture uncertainty surrounding the risk-benefit trade-off.

Results: We illustrate this approach in major cardiovascular studies, including in the TIMI 50 trial of vorapaxar vs. placebo in post-myocardial infarction, where ischaemic benefits are accompanied by increased risk of major bleeding and a meta-analysis of 6 studies in coronary patients receiving a stent, with the goal of identifying the relative risks of thrombosis and bleeding for individual high risk patients and

Conclusions: Our findings illustrate how quantitative methods can help to individualize treatment to patients who will most benefit.


Authors who are presenting talks have a * after their name.

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