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“A research journal serves that narrow

borderland which separates the known from the unknown”

-P.C.Mahalanobis


Fundamentals of clinical trials / (Record no. 420868)

MARC details
000 -LEADER
fixed length control field 03815 a2200289 4500
001 - CONTROL NUMBER
control field 136823
003 - CONTROL NUMBER IDENTIFIER
control field ISI Library, Kolkata
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20230203020005.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 160510b xxu||||| |||| 00| 0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9783319185385
040 ## - CATALOGING SOURCE
Original cataloging agency ISI Library
Language of cataloging eng
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.50724
Edition number 23
Item number F911
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Friedman, Lawrence M.
245 10 - TITLE STATEMENT
Title Fundamentals of clinical trials /
Statement of responsibility, etc Lawrence M. Friedman...[et al.].
250 ## - EDITION STATEMENT
Edition statement 5th ed
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc Cham :
Name of publisher, distributor, etc Springer,
Date of publication, distribution, etc 2015.
300 ## - PHYSICAL DESCRIPTION
Extent xxi, 550 p. :
Other physical details illustrations ;
Dimensions 25 cm.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note 1. Introduction to Clinical Trials --<br/>2. Ethical Issues --<br/>3. What is the Question? --<br/>4. Study Population --<br/>5. Basic Study Design --<br/>6. The Randomization Process --<br/>7. Blinding --<br/>8. Sample Size --<br/>9. Baseline Assessment --<br/>10. Recruitment of Study Participants --<br/>11. Data Collection and Quality Control --<br/>12. Assessment and Reporting of Harm --<br/>13. Assessment of Health Related Quality of Life --<br/>14. Participant Adherence --<br/>15. Survival Analysis --<br/>16. Monitoring Committee Structure & Function --<br/>17. Statistical Methods Used in Interim Monitoring --<br/>18. Issues in Data Analysis --<br/>19. Closeout --<br/>20. Reporting and Interpreting of Results --<br/>21. Multicenter Trials --<br/>22. Regulatory Issues --<br/>Index.
520 ## - SUMMARY, ETC.
Summary, etc This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical trials.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Furberg, Curt D.,
Relator term author
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name DeMets, David L.,
Relator term author
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Reboussin, David M.,
Relator term author
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Granger, Christopher B.,
Relator term author
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Dewey Decimal Classification
Koha item type Books
Koha issues (borrowed), all copies 1
Holdings
Lost status Not for loan Home library Current library Date acquired Cost, normal purchase price Full call number Accession Number Koha item type
    ISI Library, Kolkata ISI Library, Kolkata 31/03/2016 4054.18 615.50724 F911 136823 Books
Library, Documentation and Information Science Division, Indian Statistical Institute, 203 B T Road, Kolkata 700108, INDIA
Phone no. 91-33-2575 2100, Fax no. 91-33-2578 1412, ksatpathy@isical.ac.in