?5 July 2019 at 12:00
MRC Hubs for Trials Met?hodology Research - Trial Conduct Working Group webinar
How to design a dose-finding study using the Continual Reassessment Method
Presenters:
Simon Bond, NIHR Cambridge Clinical Trials Unit, University of Cambridge
Graham Wheeler, Cancer Research UK & UCL Cancer Trials Centre
Christina Yap, The Institute of Cancer Research, London
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Summary
The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM has been shown to be more accurate in targeting the MTD than traditional rule-based approaches such as the 3?+?3 design, which is used in most phase I trials. However, the CRM's uptake in clinical research has been incredibly slow, putting trial participants, drug development and patients at risk.
We present a structured framework for designing a dose-finding study using the CRM. We provide recommendations for key design parameters, advice on conducting pre-trial simulation work to tailor the trial's design, and guidance on how to conduct and report dose-finding studies using the CRM. We also run through an example case-study where the CRM has been applied in practice. Our associated paper (Wheeler et al., 2019; BMC Med Res Methodol<https://doi.org/10.1186/s12874-018-0638-z>) also provides practical tools to support clinicians and statisticians, including software recommendations, and template text and tables that can be edited and inserted into a trial protocol.
Lastly, we will present dtp-crm, a newly developed interactive web application that can be used to design and conduct a CRM through a useful visual tool, Dose Transition Pathways (Yap et al., 2017; Clinical Cancer Research<http://clincancerres.aacrjournals.org/content/23/24/7440>).
If you wish to attend this lunchtime webinar (approx. 40 minutes), please join by clicking this link: https://bluejeans.com/627417375
(Pre-registration is not required)
A recording of this webinar will be made available alongside previous webinars at
https://www.mrc-phru.ox.ac.uk/webinars/
http://www.methodologyhubs.mrc.ac.uk/resources/webinars/
The Institute of Cancer Research: Royal Cancer Hospital, a charitable Company Limited by Guarantee, Registered in England under Company No. 534147 with its Registered Office at 123 Old Brompton Road, London SW7 3RP.
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