MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02301nam a2200265 a 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
vtls000056819 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
KUKTEM |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20251117150324.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
111210t2011 flua f 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781439849613 |
| 039 #9 - LEVEL OF BIBLIOGRAPHIC CONTROL AND CODING DETAIL [OBSOLETE] |
|---|
| Level of rules in bibliographic description |
201202091239 |
| Level of effort used to assign nonsubject heading access points |
asmadi |
| -- |
201112101137 |
| -- |
shah |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
UMP |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN) |
|---|
| Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) |
RM301.27 .C46 2011 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Chow, Shein-Chung |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Controversial statistical issues in clinical trials / |
| Statement of responsibility, etc. |
Shein-Chung Chow |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
Boca Raton, FL : |
| Name of publisher, distributor, etc. |
Chapman and Hall/CRC, |
| Date of publication, distribution, etc. |
2011 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xix, 591 p. : |
| Other physical details |
ill. ; |
| Dimensions |
25 cm. |
| 490 0# - SERIES STATEMENT |
|---|
| Series statement |
Chapman & Hall/CRC biostatistics series |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc. note |
Includes bibliographical references (p. 553-575) and index |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
"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. "-- |
| Assigning source |
Provided by publisher |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Drugs |
| General subdivision |
Testing |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Drug development |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Clinical trials |