The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations.
J Biopharm Stat
; 30(6): 1026-1037, 2020 11 01.
Article
em En
| MEDLINE
| ID: mdl-32941098
ABSTRACT
The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma. The study is conducted under a master protocol and utilizes a crossover design with each participant receiving up to five interventions and at least one placebo. Treatment assignments are based on the patients' biomarker profiles and precision health methods are incorporated into the interim and final analyses. We describe key elements of the PrecISE study including the multistage adaptive enrichment strategy, early stopping of an intervention for futility, power calculations, and the primary analysis strategy.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Asma
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Limite:
Humans
Idioma:
En
Revista:
J Biopharm Stat
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Nova Caledônia