On the feasibility of pediatric dose-finding trials in small samples with information from a preceding trial in adults.
J Biopharm Stat
; 32(5): 652-670, 2022 09 03.
Article
en En
| MEDLINE
| ID: mdl-34962850
ABSTRACT
We consider the case of pediatric dose-finding trials with extremely limited sample size. The operating characteristics of the standard design, the Continual Reassessment Method (CRM), are only well described for sample sizes of about 20 patients or more. In this simulation study, we assume the situation of a pediatric trial with only 10 patients and a preceding dose-finding trial in adults. Based on the adult data, we reduce the set of pediatric doses and formulate (partially) informative prior distributions for the pediatric trial. Our simulations show that such small pediatric dose-finding trials with robustified priors may provide sufficient operating characteristics.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
Tipo de estudio:
Diagnostic_studies
/
Prognostic_studies
Límite:
Child
/
Humans
Idioma:
En
Revista:
J Biopharm Stat
Asunto de la revista:
FARMACOLOGIA
Año:
2022
Tipo del documento:
Article