Overview
Randomised trials are challenging to conduct and even when well designed, post-randomisation events will occur during follow-up which affect the interpretation of results. For instance, patients may stop taking their allocated treatment and/or withdraw from the study, they may receive rescue medication, or they may die before the outcome can be measured. These issues can pose a challenge to the interpretation of the trial, and are often the source of debate around the validity of results.
In November 2019, ICH issued an addendum to ICH E9 (R1) (1) entitled Estimands and Sensitivity Analyses in clinical trials to address such issues. In this webinar we will summarise the detail in ICH E9 (R1) (1) and how it impacts clinical development plans.
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Tim Clark, Dip. Stat., PhD
Dr Tim Clark gained his PhD in clinical trial methodology at the Institute for Medical Informatics, Biometry and Epidemiology (IBE), Ludwig-Maximilians-University, Munich. Tim is part of the Drug Development Services group, which provides strategic drug development advice to customers and internal teams. Tim specialises in clinical study design and protocol optimisation.
Prior to joining ICON in 2009, Tim worked in clinical research and regulatory affairs for large French and American pharmaceutical companies and as an independent consultant advising on a range of drug development issues. He has worked on small molecule and biological (including biosimilars) programmes indicated for cancer as well as CNS, autoimmune, cardiovascular and infectious diseases.
Tim has published on clinical study design, protocol optimisation and sample size determination in peer reviewed journals and is currently an Honorary Associate Professor at the Institute of Clinical Trials & Methodology, University College London.
Addendum on estimands and sensitivity analyses in clinical trials to the guideline on statistical principles for clinical trials, ICH E9 (R1). Available at https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf