Abstract Treatment outcomes for pediatric patients with acute myeloid leukemia (AML) have
continued to lag behind outcomes reported for children with acute lymphoblastic leukemia …

Misgivings have been raised about the operating characteristics of the canonical 3+ 3 dose-
escalation phase I clinical trial design. Yet, the traditional 3+ 3 design is still the most …

In the era of immunotherapies and targeted therapies, the focus of early phase clinical trials
has shifted from finding the maximum tolerated dose to identifying the optimal biological …

In the era of targeted therapy, there has been increasing concern about the development of
oncology drugs based on the “more is better” paradigm, developed decades ago for …

Conventional designs for choosing a dose for a new therapy may select doses that are
unsafe or ineffective and fail to optimize progression-free survival time, overall survival time …

Bayesian adaptive designs provide a critical approach to improve the efficiency and success
of drug development that has been embraced by the US Food and Drug Administration …

Due to the small sample sizes in early-phase clinical trials, the toxicity and efficacy profiles of
the dose-schedule regimens determined for subsequent trials may not be well established …

Background The traditional more-is-better dose selection paradigm, originally developed for
cytotoxic chemotherapeutics, can be problematic when applied to the development of novel …

One of the primary objectives of an oncology dose‐finding trial for novel therapies, such as
molecular targeted agents and immune‐oncology therapies, is to identify an optimal dose …

Abstract Bayesian Optimal Interval (BOIN) designs are a class of model-assisted dose-
finding designs that can be used in oncology trials to determine the maximum tolerated dose …