Olga Solovyeva, PhD, The Institute of Cancer Research, Sutton, UK, discusses her study on redeveloping the SPIRIT and CONSORT extensions for early phase dose-finding (EPDF) trials. The DEFINE (Dose Finding Extensions) study aims to improve transparency, completeness, reproducibility, and interpretation of EPDF trials. During the study, Dr Solovyeva and her team organised a two round Delphi process and were pleased with results. Following this, a two-day consensus meeting was held resulting in the current useability testing of the SPIRIT-DEFINE and CONSORT-DEFINE checklists. From these redeveloped guidelines, a refreshed starting dose regimen can be expected, dose escalation strategies have been implemented, and a criterion for reporting results of outcomes at each dose level has been developed. This interview took place at the ESMO Targeted Anticancer Therapies (TAT) Congress 2023 in Paris, France.
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