A1183
Title: Guidance on statistical items in the SPIRIT and CONSORT extensions for early phase dose-finding clinical trials
Authors: Christina Yap - The Institute of Cancer Research (United Kingdom) [presenting]
Abstract: Early-phase dose-finding (EPDF) trials are vital for developing new interventions. They are typically phase I or I/II trials that use adaptive dose escalation/de-escalation strategies to determine a safe and potentially active dose range for subsequent trials. The quality of EPDF trial protocols and reports was notably variable and suboptimal. Consequently, the DEFINE (DosE FIndiNg Extensions) study has developed consensus-driven extensions for EPDF trial protocols (SPIRIT-DEFINE) and trial reports (CONSORT-DEFINE) based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 and CONSORT (CONsolidated Standards Of Reporting Trials) 2010 guidelines. The focus is on both guidelines' statistical aspects of the new and modified items. Such items include a detailed elaboration of the trial design (e.g., adaptive features, the timing of interim analyses, planned dose range with starting dose(s), dose allocation method, interim decision-making criteria, expansion cohort(s), operating characteristics), clear definitions of analysis populations, and plans for handling intercurrent events. The importance of including specific items will be stressed, and practical advice will be offered with examples of how to address them. Implementing both guidelines will facilitate transparency, comprehensiveness and reproducibility of methods and reduce research inefficiencies in EDPF trials. Funder: UK MRC/NIHR. Presented on behalf of the DEFINE Group
