MARC details
| 000 -LEADER |
|---|
| fixed length control field |
05331cam a22006135i 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
21733045 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20230322143637.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS |
|---|
| fixed length control field |
m |o d | |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
|---|
| fixed length control field |
cr ||||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
150827s2015 gw |||| o |||| 0|eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
|---|
| LC control number |
2019750767 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9783319185392 |
| 024 7# - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.1007/978-3-319-18539-2 |
| Source of number or code |
doi |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(DE-He213)978-3-319-18539-2 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DLC |
| Language of cataloging |
eng |
| Description conventions |
pn |
| -- |
rda |
| Transcribing agency |
DLC |
| 060 ## - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
|---|
| Classification number |
QV 771 |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MBNS |
| Source |
thema |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MED090000 |
| Source |
bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
PBT |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
PBT |
| Source |
thema |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
519.5 |
| Edition number |
23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Friedman, Lawrence M, |
| Relator term |
author. |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Fundamentals of Clinical Trials / |
| Statement of responsibility, etc. |
by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
5th ed. 2015. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
Cham : |
| Name of producer, publisher, distributor, manufacturer |
Springer International Publishing : |
| -- |
Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2015. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
1 online resource (XXI, 550 pages 49 illustrations, 7 illustrations in color.) |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS |
|---|
| File type |
text file |
| Encoding format |
PDF |
| Source |
rda |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Introduction to Clinical Trials -- Ethical Issues -- What is the Question? -- Study Population -- Basic Study Design -- The Randomization Process -- Blinding -- Sample Size -- Baseline Assessment -- Recruitment of Study Participants -- Data Collection and Quality Control -- Assessment and Reporting of Harm -- Assessment of Health Related Quality of Life -- Participant Adherence -- Survival Analysis -- Monitoring Committee Structure and Function -- Statistical Methods Used in Interim Monitoring -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials -- Regulatory Issues. |
| 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. |
| 588 ## - SOURCE OF DESCRIPTION NOTE |
|---|
| Source of description note |
Description based on publisher-supplied MARC data. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Cancer research. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Epidemiology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Oncology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Public health. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Statistics. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Statistics for Life Sciences, Medicine, Health Sciences. |
| Authority record control number or standard number |
https://scigraph.springernature.com/ontologies/product-market-codes/S17030 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Cancer Research. |
| Authority record control number or standard number |
https://scigraph.springernature.com/ontologies/product-market-codes/B11001 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Epidemiology. |
| Authority record control number or standard number |
https://scigraph.springernature.com/ontologies/product-market-codes/H63000 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Oncology. |
| Authority record control number or standard number |
https://scigraph.springernature.com/ontologies/product-market-codes/H33160 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Public Health. |
| Authority record control number or standard number |
https://scigraph.springernature.com/ontologies/product-market-codes/H27002 |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
DeMets, David L, |
| Relator term |
author. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Furberg, Curt D, |
| Relator term |
author. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Granger, Christopher B, |
| Relator term |
author. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Reboussin, David M, |
| Relator term |
author. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Print version: |
| Title |
Fundamentals of clinical trials. |
| International Standard Book Number |
9783319185385 |
| Record control number |
(DLC) 2015942127 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783319185385 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783319185408 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783319307732 |
| 906 ## - LOCAL DATA ELEMENT F, LDF (RLIN) |
|---|
| a |
0 |
| b |
ibc |
| c |
origres |
| d |
u |
| e |
ncip |
| f |
20 |
| g |
y-gencatlg |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
National Library of Medicine |
| Koha item type |
Books |
| Suppress in OPAC |
No |
