A roadmap to using historical controls in clinical trials – by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG)

A roadmap to using historical controls in clinical trials – by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG)

Abstract Historical controls (HCs) can be used for model parameter estimation at the study design phase, adaptation within a study, or supplementation or replacement of a control arm. Currently on the latter, there is no practical roadmap from design to analysis of a clinical trial to address select...

Ausführliche Beschreibung

Bibliographische Detailangaben
Hauptverfasser: Mercedeh Ghadessi, Rui Tang, Joey Zhou, Rong Liu, Chenkun Wang, Kiichiro Toyoizumi, Chaoqun Mei, Lixia Zhang, C. Q. Deng, Robert A. Beckman
Format: Artikel
Sprache:English
Veröffentlicht: BMC 2020-03-01
Schriftenreihe:Orphanet Journal of Rare Diseases
Schlagworte:
Historical control
Clinical trial
Simulation
Sensitivity analysis
Rare disease
Pediatric indication
Online Zugang:http://link.springer.com/article/10.1186/s13023-020-1332-x

Online

http://link.springer.com/article/10.1186/s13023-020-1332-x

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