Looking ahead in early-phase trial design to improve the drug development process: examples in oncology.

ABSTRACT:

Background

Clinical trial design must consider the specific resource constraints and overall goals of the drug development process (DDP); for example, in designing a phase I trial to evaluate the safety of a drug and recommend a dose for a subsequent phase II trial. Here, we focus on design considerations that involve the sequence of clinical trials, from early phase I to late phase III, that constitute the DDP.

Methods

We discuss how stylized simulation models of clinical trials in an oncology DDP can quantify important relationships between early-phase trial designs and their consequences for the remaining phases of development. Simulations for three illustrative settings are presented, using stylized models of the DDP that mimic trial designs and decisions, such as the po

SUBMITTER: Vanderbeek AM 

PROVIDER: S-EPMC10308797 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature