Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials.

Zhang, Jenny J; Zhang, Lijun; Chen, Huanyu; Murgo, Anthony J; Dodd, Lori E; Pazdur, Richard; Sridhara, Rajeshwari

Zhang, Jenny J; Zhang, Lijun; Chen, Huanyu; Murgo, Anthony J; Dodd, Lori E; Pazdur, Richard; Sridhara, Rajeshwari.

Affiliation

Zhang JJ; Division of Biometrics V/Office of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA.

Clin Cancer Res ; 19(10): 2637-45, 2013 May 15.

Article in En | MEDLINE | ID: mdl-23532893

Subject(s)

Clinical Audit/methods; Endpoint Determination/methods; Neoplasms/drug therapy; Outcome Assessment, Health Care/methods; Algorithms; Bias; Carcinoid Tumor/drug therapy; Carcinoid Tumor/pathology; Clinical Trials, Phase III as Topic; Disease Progression; Disease-Free Survival; Everolimus; Humans; Immunosuppressive Agents/therapeutic use; Neoplasms/pathology; Randomized Controlled Trials as Topic; Reproducibility of Results; Sarcoma/drug therapy; Sarcoma/pathology; Sirolimus/analogs & derivatives; Sirolimus/therapeutic use

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Outcome Assessment, Health Care / Endpoint Determination / Clinical Audit / Neoplasms Type of study: Clinical_trials Limits: Humans Language: En Journal: Clin Cancer Res Journal subject: NEOPLASIAS Year: 2013 Type: Article Affiliation country: United States

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