Quality control of oncology clinical trials

被引：7

作者：

Meyerson, LJ ^{[1
]}

Wiens, BL ^{[1
]}

LaVange, LM ^{[1
]}

Koutsoukos, AD ^{[1
]}

机构：

[1] Quintiles Inc, Dept Biostat, Kansas City, MO 64137 USA

来源：

HEMATOLOGY-ONCOLOGY CLINICS OF NORTH AMERICA | 2000年 / 14卷 / 04期

关键词：

D O I：

10.1016/S0889-8588(05)70321-X

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

This article discusses issues that are essential to ensuring the reliability of the conclusions of oncology clinical trials. Though quality control is important at every stage of a well-run clinical trial, the authors focus on the quality of the data as evidenced by the results and conclusions of the study. Good quality control principles and practices are discussed for study planning, design, conduct, analysis, and interpretation.

引用

页码：953 / +

页数：20

共 31 条

[1]

[Anonymous], 1997, CLIN TRIALS ONCOLOGY

[2]

Baines CJ, 1997, CANCER-AM CANCER SOC, V80, P720

[3]

PROVING THE NULL HYPOTHESIS IN CLINICAL-TRIALS [J].

BLACKWELDER, WC .

CONTROLLED CLINICAL TRIALS, 1982, 3 (04) :345-353

[4]

BUYSE M, 1984, CANCER CLIN TRIALS, P102

[5]

THE NATIONAL-CANCER-INSTITUTE AUDIT OF THE NATIONAL-SURGICAL-ADJUVANT-BREAST-AND-BOWEL-PROJECT-PROTOCOL-B-06 [J].

CHRISTIAN, MC ;

MCCABE, MS ;

KORN, EL ;

ABRAMS, JS ;

KAPLAN, RS ;

FRIEDMAN, MA .

NEW ENGLAND JOURNAL OF MEDICINE, 1995, 333 (22) :1469-1474

[6]

DEPAUW M, 1984, CANC CLIN TRIALS, P64

[7]

Interobserver variability in the detection of cervical-thoracic Hodgkin's disease by computed tomography [J].

Fletcher, BD ;

Glicksman, AS ;

Gieser, P .

JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (07) :2153-2159

[8]

FRIEDMAN JLM, 1981, FUNDAMENTALS CLIN TR

[9]

ASSESSING CLINICAL-TRIALS - RECORD SHEETS [J].

GORE, SM .

BRITISH MEDICAL JOURNAL, 1981, 283 (6286) :296-298

[10]

POLICIES FOR STUDY MONITORING AND INTERIM REPORTING OF RESULTS [J].

GREEN, SJ ;

FLEMING, TR ;

OFALLON, JR .

JOURNAL OF CLINICAL ONCOLOGY, 1987, 5 (09) :1477-1484

← 1 2 3 4 →