Time: 10:30 - 12:30 UK Time Presenters: Mahesh Parmar (Medical Research Council), James Matcham (AstraZeneca) and Julia Saperia (Medicines and Healthcare products Regulatory Agency)
Trials designed to answer a range of questions, often incorporating multiple treatment arms are increasingly being considered in all phases of clinical research in both the pharmaceutical industry and public sector trials. A variety of terms including platform, umbrella and basket designs have been used to describe particular versions of this general framework. During this webinar a regulatory speaker will consider what is meant by the different terms and potential regulatory hurdles, while speakers from industry and the public sector will share their practical experiences of these types of trials.
Mahesh Parmar, MRC Clinical Trials Unit at UCL
Testing many treatments within a single protocol over 10 years at the MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols
There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone. Ultimately, we often find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this presentation, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
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