Using more information for fewer patients.
BackOne2Treat significantly enhanced a Phase III oncology trial by expanding its design to include analysis of adverse event (AE) severity and duration, beyond mere occurrence. Adapting the trial’s primary endpoint to include these multiple clinically relevant outcomes allowed for a more comprehensive assessment of the treatment effect, in line with the wishes of patients-advocacy group. This innovation led to a 19% reduction in sample size and over 20% faster recruitment, demonstrating our commitment to efficient, patient-centric clinical research. This advancement underscores our capability to streamline clinical development, offering quicker, more cost-effective paths to new treatments.