Methods for proper handling of overrunning and underrunning in phase II designs for oncology trials.

Englert, Stefan; Kieser, Meinhard

Englert, Stefan; Kieser, Meinhard.

Affiliation

Englert S; Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, D-69120 Heidelberg, Germany.

Stat Med ; 34(13): 2128-37, 2015 Jun 15.

Article in En | MEDLINE | ID: mdl-25781860

Subject(s)

Clinical Trials, Phase II as Topic/standards; Medical Oncology/standards; Bias; Carcinoid Tumor/drug therapy; Clinical Trials, Phase II as Topic/methods; Clinical Trials, Phase II as Topic/statistics & numerical data; Endpoint Determination; Humans; Medical Oncology/methods; Medical Oncology/statistics & numerical data; Multicenter Studies as Topic/methods; Multicenter Studies as Topic/standards; Multicenter Studies as Topic/statistics & numerical data; Research Design/standards; Research Design/statistics & numerical data; Sample Size; Treatment Outcome

Key words

clinical trials; conditional error function; discrete data; overrunning; phase II; two-stage design; underrunning

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Clinical Trials, Phase II as Topic / Medical Oncology Type of study: Clinical_trials / Prognostic_studies Limits: Humans Language: En Journal: Stat Med Year: 2015 Document type: Article Affiliation country: Germany

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