PA‐CRM: A continuous reassessment method for pediatric phase I oncology trials with concurrent adult trials

Yimei Li and Ying Yuan

Biometrics, 2020, vol. 76, issue 4, 1364-1373

Abstract: Pediatric phase I trials are usually carried out after the adult trial testing the same agent has started, but not completed yet. As the pediatric trial progresses, in light of the accrued interim data from the concurrent adult trial, the pediatric protocol often is amended to modify the original pediatric dose escalation design. In practice, this is done frequently in an ad hoc way, interrupting patient accrual and slowing down the trial. We developed a pediatric‐continuous reassessment method (PA‐CRM) to streamline this process, providing a more efficient and rigorous method to find the maximum tolerated dose for pediatric phase I oncology trials. We use a discounted joint likelihood of the adult and pediatric data, with a discount parameter controlling information borrowing between pediatric and adult trials. According to the interim adult and pediatric data, the discount parameter is adaptively updated using the Bayesian model averaging method. Numerical study shows that the PA‐CRM improves the efficiency and accuracy of the pediatric trial and is robust to various model assumptions.

Date: 2020
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