Model of a Queuing Approach for Patient Accrual in Phase 1 Oncology Studies

Key Points Question Can the duration of phase 1 studies using either the 3 + 3 or rolling 6 designs be substantially reduced without exceeding the patient risk limits or changing the operating characteristics of the parent design? Findings This decision analytical model found that the modified study designs were associated with reduced expected study durations. The modified designs were associated with minimal changes in the number of patients treated and the determination of the maximum tolerated dose, without changing the operating characteristics or exceeding the risk limits of the parent design. Meaning Per this analysis, a substantial reduction in the time required to bring new advances to the clinic can be accomplished by simple modifications of 2 commonly used phase 1 trial designs.