02301nam a2200265 a 4500 vtls000056819 KUKTEM 20251117150324.0 111210t2011 flua f 001 0 eng d 9781439849613 201202091239 asmadi 201112101137 shah UMP RM301.27 .C46 2011 Chow, Shein-Chung Controversial statistical issues in clinical trials / Shein-Chung Chow Boca Raton, FL : Chapman and Hall/CRC, 2011 xix, 591 p. : ill. ; 25 cm. 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. "-- Provided by publisher Drugs Testing Drug development Clinical trials 0 0 0 0 10000 10000 2019-09-04 306.38 0 RM301.27 .C46 2011 0000062065 2019-09-04 00:00:00 1 306.38 2019-09-04 OPEN VIRTUA40 55994 56000 VTLSSORT0080*0200*0400*0900*1000*2450*2600*3000*4900*5040*5200*6500*6501*6502*9991