PSI Journal Club: Limitations and Challenges with Mixed Model Repeated Measures (MMRM) Analysis
Moses Mwangi and Florian Lasch present their recent work on MMRM, with discussion lead by Geert Molenberghs.
Date: Tuesday 25th May 2021
Time: 14:00 - 17:00 BST
Speakers: Rachel Hodge (AstraZeneca), Thomas Jaki (MRC Biostatistics Unit), Archan Bhattacharya (Janssen), Nigel Stallard (University of Warwick) and Emma Clark (Roche).
Who is this event intended for? All statisticians from research/academia/Pharma industries, especially those working in Oncology.
What is the benefit of attending? To learn more about hot topics in oncology clinical trials design and analysis and to be able to interact with speakers and likeminded colleagues in an open, informal and focussed environment.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = £20+VAT
To register for the session, please click here.
The format of this event will include Ted-Style Talks by all of our speakers with the opportunity for us to have a discussion together after each of the presentations.
Why this meeting?
Effective treatment, early detection and prevention of cancer remain fundamental challenges to current clinical research. Discovering and developing successful oncology treatments requires design and execution of an increasing variety of clinical studies, calling for a commensurate range of fit-for-purpose statistical methods. Clinical statisticians working in oncology are thus exposed to a flow of evolving objectives, endpoints, measurement technologies, methodological and operational challenges.
What to expect?
The objective of this PSI virtual meeting is to enable practical interaction among clinical statisticians actively working in oncology and those interested to work in this area. The simple format of this meeting specifically facilitates these interactions, by balancing equally time dedicated to a sequence of short, engaging talks covering a broad range of relevant topics and to Q&A. A breakout session halfway through the meeting will also enable casual interactions with the speakers and among meeting participants.
Speaker |
Biography |
Abstract |
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Rachel Hodge is Director and Biometric Team Leader at AstraZeneca which she joined 6 years ago. Rachel led the development of Tagrisso in NSCLC through its multiple filings and designed several studies. Rachel is also the statistical lead for the ctDNA workstream at AstraZeneca. Previously, Rachel worked at GSK where she designed and reported several phase 2 and phase 3 oncology trials. Rachel holds an MSc in Statistics from the University of Sheffield. |
Expanding Uses for ctDNA in Clinical Trial Design |
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Thoughts on Late-Onset Toxicities in dose-finding studies Phase I dose-finding trials often seek to identify the maximum tolerated dose; the dosewith a particular risk of toxicity and only toxicities during the first cycle of therapy are used for this purpose.A course of treatment frequently consists of multiple cycles of therapy, however, so that theoverall risk of toxicity for a given treatment is not fully encapsulated by observations from the first cycle. This talk will discuss the challenges that arise when the toxicity period is extended and discuss different methods to account for such late onset toxicities |
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Archan Bhattacharya is a clinical statistician at Janssen, working on design and analysis of lung cancer trials. Prior to joining Janssen, Archan worked at PAREXEL where he supported oncology development programs targeting solid tumours and multiple myeloma with small molecules, drug-antibody conjugates and T-cell therapy. Prior to working in oncology, Archan was a CRO statistician on phase III/IV rheumatoid arthritis trials. He received his PhD in Statistics from the University of Georgia focusing in on Bayesian inference and computation. He has been a research fellow at the University of Nottingham, working on the identification of contributing factors in osteoarthritis to reduce disease burden through life-style changes and social awareness. He taught Statistics at different levels in universities in India. |
Integration of real world data in oncology early development studies |
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Nigel Stallard is Professor of Medical Statistics, Head of the Statistics and Epidemiology Group and Deputy Head of the Division of Health Sciences at Warwick Medical School. Professor Stallard's primary research interests are in the statistical design and analysis of clinical trials. In particular, he has worked on optimal trial design and on methodology for clinical trials with interim analyses and adaptations such as treatment selection. His most recent work involves the use of short-term endpoint data for decision-making during the course of a clinical trial and the development of innovative methods for clinical trials in small populations. |
Multiplicity in confirmatory clinical trials with master protocol designs Recent advances in tumour biology and targeted therapies have led to clinical trials considering treatment effects in multiple subgroups of the patient population. These can lead to efficiency gains by testing several statistical hypotheses in the same clinical trial. Recently proposed approaches include adaptive enrichment, umbrella and basket trial designs. Although much of the development of novel designs has been in exploratory phase II trials, there is growing interest in such methods in confirmatory randomized controlled trials. These might be phase III trials with subgroup analyses or phase II/III trials combining exploratory and confirmatory elements. In such a setting, the multiple hypothesis tests can lead to statistical error rate inflation and hence to the question of when statistical correction for multiplicity should be implemented. This talk will survey the novel design approaches for clinical trials with subgroups and explore the multiplicity issues that arise. Based on this, a proposal will be made for when multiplicity corrections are needed for confirmatory trials employing such innovative designs. |
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Emma Clark is a Principal Statistical Scientist working at Roche Products Ltd, UK. She has 30 years’ experience in the Pharmaceutical industry and started her career at the AstraZeneca UK Marketing Company working across a broad range of therapeutic areas. Emma joined Roche in 2008 where she has focussed solely on Oncology Clinical Trials in both solid tumours and haematology. |
FDA Complex Innovative Design Pilot: experience of using external control data to analyse secondary endpoints |
Cancellation and Moderation Terms
For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.