PSI Webinar: Oncology Ted Talks (with interaction)

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Date: Tuesday 25th May 2021
Time: 14:00 - 17:00 BST
Speakers: Vincent Haddad (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 hear more about the uses for ctDNA in Clinical Trial Design, integration of real world data in early development studies, multiplicity in confirmatory clinical trials with master protocol designs and thoughts on late-onset toxicities in dose-finding studies. 


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 Talks by all of our speakers with the opportunity for us to have a discussion together after each of the presentations.

Speaker details




Vincent Haddad Astrazeneca

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Expanding Uses for ctDNA in Clinical Trial Design

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Thomas Jaki
MRC Biostatistics Unit

Professor Thomas Jaki recently joined the MRC Biostatistics clinical trial unit in Cambridge as a Programme Leader in the DART theme. Thomas has been Professor of Statistics at University of Lancaster, where he has led several substantial research projects and is head of Medical Statistics. His work has focused on developing and evaluating novel statistical methods for clinical and pre-clinical studies. These methods are adapted for specific applications to ensure they can be used in the pharmaceutical industry and in public sector research institutions. Thomas will lead this evolving research theme into a new era, developing new streams of clinical trials tackling current public health challenges, including COVID-19.

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

Archan Bhattacharya

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
University of Warwick

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.

Emma Clark

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FDA Complex Innovative Design Pilot: experience of using external control data to analyse secondary endpoints

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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.

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