Phase I/II dose-finding design for molecularly targeted agent: Plateau determination using adaptive randomization

Conventionally, phase I dose-finding trials aim to determine the maximum tolerated dose of a new drug under the assumption that both toxicity and efficacy monotonically increase with the dose. This paradigm, however, is not suitable for some molecularly targeted agents, such as monoclonal antibodies...

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Veröffentlicht in:	Statistical methods in medical research 2018-02, Vol.27 (2), p.466-479
Hauptverfasser:	Riviere, Marie-Karelle, Yuan, Ying, Jourdan, Jacques-Henri, Dubois, Frédéric, Zohar, Sarah
Format:	Artikel
Sprache:	eng
Schlagworte:	Age of onset Antibodies Bayesian analysis Bioengineering Clinical research Clinical trials Computer simulation Effectiveness Efficacy Life Sciences Medical research Monoclonal antibodies Pharmaceutical sciences Simulation Toxicity
Online-Zugang:	Volltext
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