A Road Map for Designing Phase I Clinical Trials of Radiotherapy-Novel Agent Combinations.

ABSTRACT: Radiotherapy has proven efficacy in a wide range of cancers. There is growing interest in evaluating radiotherapy-novel agent combinations and a drive to initiate this earlier in the clinical development of the novel agent, where the scientific rationale and preclinical evidence for a radiotherapy combination approach are high. Optimal design, delivery, and interpretation of studies are essential. In particular, the design of phase I studies to determine safety and dosing is critical to an efficient development strategy. There is significant interest in early-phase research among scientific and clinical communities over recent years, at a time when the scrutiny of the trial methodology has significantly increased. To enhance trial design, optimize safety, and promote efficient trial conduc

SUBMITTER: Brown SR 

PROVIDER: S-EPMC9433953 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature