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Controversial statistical issues in ...

Chow, Shein-Chung, (1955-)

Controversial statistical issues in clinical trials

Record Type:	Electronic resources : Monograph/item
Title/Author:	Controversial statistical issues in clinical trialsShein-Chung Chow.
Author:	Chow, Shein-Chung,
Published:	Boca Raton :CRC Press,c2011.
Description:	1 online resource (xix, 591 p.) :ill.
Subject:	DrugsTesting.
Online resource:	http://www.crcnetbase.com/isbn/9781439849620
ISBN:	9781439849620 (electronic bk.)

Controversial statistical issues in clinical trials
Chow, Shein-Chung,1955-

Controversial statistical issues in clinical trials[electronic resource] /Shein-Chung Chow. - Boca Raton :CRC Press,c2011. - 1 online resource (xix, 591 p.) :ill. - Chapman & Hall/CRC biostatistics series. - Chapman & Hall/CRC biostatistics series..

Includes bibliographical references (p. 553-575) and index.

"Preface In pharmaceutical/clinical development of a test drug or treatment, relevant clinical data are usually collected from subjects with the diseases under study in order to evaluate safety and efficacy of the test drug or treatment under investigation. To provide accurate and reliable assessment, well-controlled clinical trials under valid study design are necessarily conducted. Clinical trial process is a lengthy and costly process, which is necessary to ensure a fair and reliable assessment of the test treatment under investigation. Clinical trial process consists of protocol development, trial conduct, data collection, statistical analysis/interpretation, and reporting. In practice, controversial issues evitably occur regardless the compliance of good statistical practice (GSP) and good clinical practice (GCP). Controversial issues in clinical trials are referred to as debatable issues that are commonly encountered during the conduct of clinical trials. In practice, controversial issues could be raised from, but are not limited to, (1) compromises between theoretical and real/common practices, (2) miscommunication and/or misunderstanding in perception/interpretation among regulatory agencies, clinical scientists, and biostatisticians, and (3) disagreement, inconsistency, miscommunication/misunderstanding, and errors in clinical practice. "--

ISBN: 9781439849620 (electronic bk.)

LCCN: 2011024204Subjects--Topical Terms:

183737
Drugs
--Testing.

LC Class. No.: RM301.27 / .C475 2011

Dewey Class. No.: 615.5072/4

National Library of Medicine Call No.: QV 771

Controversial statistical issues in clinical trials
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504 $a Includes bibliographical references (p. 553-575) and index.
520 $a "Preface In pharmaceutical/clinical development of a test drug or treatment, relevant clinical data are usually collected from subjects with the diseases under study in order to evaluate safety and efficacy of the test drug or treatment under investigation. To provide accurate and reliable assessment, well-controlled clinical trials under valid study design are necessarily conducted. Clinical trial process is a lengthy and costly process, which is necessary to ensure a fair and reliable assessment of the test treatment under investigation. Clinical trial process consists of protocol development, trial conduct, data collection, statistical analysis/interpretation, and reporting. In practice, controversial issues evitably occur regardless the compliance of good statistical practice (GSP) and good clinical practice (GCP). Controversial issues in clinical trials are referred to as debatable issues that are commonly encountered during the conduct of clinical trials. In practice, controversial issues could be raised from, but are not limited to, (1) compromises between theoretical and real/common practices, (2) miscommunication and/or misunderstanding in perception/interpretation among regulatory agencies, clinical scientists, and biostatisticians, and (3) disagreement, inconsistency, miscommunication/misunderstanding, and errors in clinical practice. "-- $c Provided by publisher.
588 $a Description based on print version record.
650 0 $a Drugs $x Testing. $3 183737
650 0 $a Drug development. $3 190608
650 0 $a Clinical trials. $3 181901
650 1 2 $a Clinical Trials as Topic. $3 265581
650 1 2 $a Drug Evaluation, Preclinical. $3 226663
650 2 2 $a Data Interpretation, Statistical. $3 205961
830 0 $a Chapman & Hall/CRC biostatistics series. $3 508409
856 4 0 $u http://www.crcnetbase.com/isbn/9781439849620