Controlled backfill in oncology dose-finding trials

The use of backfill in early phase dose-finding trials is a relatively recent practice. It consists of assigning patients to dose levels below the level where the study is at. The main reason for backfilling is to collect additional pharmacokinetic, pharmacodynamic and response data, in order to ass...

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Veröffentlicht in:	Contemporary clinical trials 2021-12, Vol.111, p.106605-106605, Article 106605
Hauptverfasser:	Dehbi, Hakim-Moulay, O’Quigley, John, Iasonos, Alexia
Format:	Artikel
Sprache:	eng
Schlagworte:	Backfill Computer Simulation Continual reassessment method Dose exploration Dose-finding Dose-ranging Dose-Response Relationship, Drug Early phase Efficacy Humans Maximum Tolerated Dose Medical Oncology Neoplasms - drug therapy Oncology Plateau Research Design Response
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