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 …

Phase 1 dose-escalation trials are crucial to drug development by providing a framework to
assess the toxicity of novel agents in a stepwise and monitored fashion. Despite widely …

PURPOSE For immunotherapy, such as checkpoint inhibitors and chimeric antigen receptor
T-cell therapy, where the efficacy does not necessarily increase with the dose, the maximum …

Drug development enterprise is struggling because of prohibitively high costs and slow
progress. There is urgent need for adoption of novel adaptive designs to improve the …

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 …

Two useful strategies to speed up drug development are to increase the patient accrual rate
and use novel adaptive designs. Unfortunately, these two strategies often conflict when the …

Background With numerous and fast approvals of different agents including immune
checkpoint inhibitors, monoclonal antibodies, or chimeric antigen receptor (CAR) T-cell …

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 …

One of the primary purposes of an oncology dose‐finding trial is to identify an optimal dose
(OD) that is both tolerable and has an indication of therapeutic benefit for subjects in …

Through Project Optimus, the FDA calls for radical changes in the design of early phase
trials to identify the optimal doses of oncology drugs to achieve maximal efficacy with better …