Speaker: Dr Sarah Brown, Associate Professor of Early Phase Clinical Trials, University of Leeds
Chair: Professor Christina Yap, Professor of Clinical Trials Biostatistics, The Institute of Cancer Research
Abstract: CONCORDE is a phase I platform trial, designed to determine the recommended phase II doses (RP2Ds) of 5 DNA damage repair inhibitors in combination with radiotherapy, for patients with lung cancer. To account for long-term toxicity associated with radiotherapy, we apply the time-to-event continuous reassessment method to facilitate dose escalation and determine RP2Ds. Weighting is given to short- and long-term DLT periods in the TiTE-CRM model. A calibration cohort of patients treated with radiotherapy alone acts as a control group pooled across the platform to aid interpretation of toxicity and DLT attribution.
This event is part of the NIHR Statistics – Early Phase Trials Group webinar series on ““Practical applications of advanced designs in Phase I Trials”. Registration is free and is limited to 100 attendees. Places will be offered on a first come first served basis. A recording of the webinar will be made available after the event.
For further information, please contact Professor Christina Yap, firstname.lastname@example.org (webinar organiser and co-lead of the NIHR Statistics Group – Early Phase Clinical Trials) and Ms Tara Thorneycroft, email@example.com (event co-ordinator).
Data Protection Act: Contact details will be held on a database at the ICR-CTSU (Clinical Trials and Statistics Unit) for purposes related to the webinar only.