Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Regulatory Affairs and Drug Development Solutions (RADDS), IQVIA, Frankfurt, Germany
Research Article
Bayesian Interval Based Designs for Phase I Dose-Escalation Trials: A Case Study in Oncology
Author(s): Tim Clark, Ayon Mukherjee*, Peter Lichtlen and James Sweeney
The objective of phase I dose-escalation clinical trials has generally been to determine the Maximum Tolerated Dose (MTD). However, with the advent of molecular targeted therapies this approach has changed, as dose limiting toxicities are less frequently observed. For this reason, the concept of Optimal Biological Dose (OBD) has been developed, which considers efficacy and toxicity. Several Bayesian model-assisted designs have been proposed to target the MTD more accurately and/or the OBD compared to traditional rule-based approaches such as the 3+3 design. These include the Bayesian Optimal Interval (BOIN) and the BOIN phase I/II (BOIN12) design. The BOIN design targets the MTD, while the BOIN12, which takes both efficacy and toxicity into account in decisions to escalate/de-escalate the dose, targets the OBD. In this article we use a real-life case study to compare the BO.. View More»
DOI:
10.35248/2167-0870.24.14.566