Early Phase Adaptive Clinical Trial Design in Oncology

Adaptive clinical trials have been increasingly used in the past decades, especially in drug development. Different from traditional clinical trial design, adaptive designs allow trial modification before trial ends without affecting the validity and integrity of the trial. Consequently, the advantages of using adaptive design include increasing the study power in detecting treatment effects, decreasing trial duration and hence total cost, assigning fewer patients to inferior treatment, and reducing the time for drug development. With the use of adaptive design, early phase trials (phase I to phase II) in oncology have become more and more sophisticated and powerful, and the designs can be more flexible under the proof of concept setting compared to those for the confirmatory studies. However, there are many design considerations and practical issues while implementing such adaptive designs that many clinicians and investigators may be unfamiliar with.

With the hope to help facilitate and promote the use of adaptive phase I/II design in oncology trials, this Research Topic aims to publish research studies related to innovative adaptive designs in early phase oncology trials from case studies to innovative adaptive design and from authors with diverse backgrounds (academic research institutions, industrial companies, and government agency). The collection of publications will help summarize the recent development in adaptive designs, introduce the methodological framework of newly developed adaptive designs and provide possible solutions to existing or new statistical issues by using such designs in oncology trials. We hope the publications will inspire readers when designing new early-phase oncology studies.

Manuscript submissions addressing but not limited to the following themes will be considered for publication:

- Innovative adaptive early phase trials (Phase I, Phase I/II, Phase II) designs in oncology include but not limited to seamless Phase I/II trial design, biomarker-guided design, Bayesian adaptive design, master protocol design, etc.

- Systematic review that summarizes recent adaptive early phase trials designs in specific oncology or drug development area such as those for drug combination studies

- Case studies of applying innovative adaptive design to oncology trials

- Methods that address statistical issues in adaptive early phase trials from design to analysis

Please note: manuscripts consisting solely of bioinformatics, computational analysis, or predictions of public databases which are not accompanied by validation (independent cohort or biological validation in vitro or in vivo) will not be accepted in any of the sections of Frontiers in Oncology.