國立虎尾科技大學 |

Fundamentals of Clinical Trials

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Fundamentals of Clinical Trials/ by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger.
Author:	Friedman, Lawrence M.
other author:	Furberg, Curt D.
Description:	XXI, 550 p. 49 illus., 7 illus. in color.online resource. :
Contained By:	Springer Nature eBook
Subject:	Statistics . -
Online resource:	https://doi.org/10.1007/978-3-319-18539-2
ISBN:	9783319185392

Fundamentals of Clinical Trials
Friedman, Lawrence M.

Fundamentals of Clinical Trials[electronic resource] /by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger. - 5th ed. 2015. - XXI, 550 p. 49 illus., 7 illus. in color.online resource.

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 & Function -- Statistical Methods Used in Interim Monitoring -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials -- Regulatory Issues.

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. .

ISBN: 9783319185392

Standard No.: 10.1007/978-3-319-18539-2doiSubjects--Topical Terms:

1253516
Statistics .

LC Class. No.: QA276-280

Dewey Class. No.: 519.5

Fundamentals of Clinical Trials
LDR:04311nam a22004095i 4500 001 960073
003 DE-He213
005 20200630041947.0
007 cr nn 008mamaa
008 201211s2015 gw | s |||| 0|eng d
020 $a 9783319185392 $9 978-3-319-18539-2
024 7 $a 10.1007/978-3-319-18539-2 $2 doi
035 $a 978-3-319-18539-2
050 4 $a QA276-280
072 7 $a PBT $2 bicssc
072 7 $a MED090000 $2 bisacsh
072 7 $a PBT $2 thema
072 7 $a MBNS $2 thema
082 0 4 $a 519.5 $2 23
100 1 $a Friedman, Lawrence M. $4 aut $4 http://id.loc.gov/vocabulary/relators/aut $3 1067977
245 1 0 $a Fundamentals of Clinical Trials $h [electronic resource] / $c by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger.
250 $a 5th ed. 2015.
264 1 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2015.
300 $a XXI, 550 p. 49 illus., 7 illus. in color. $b online resource.
336 $a text $b txt $2 rdacontent
337 $a computer $b c $2 rdamedia
338 $a online resource $b cr $2 rdacarrier
347 $a text file $b PDF $2 rda
505 0 $a 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 & Function -- Statistical Methods Used in Interim Monitoring -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials -- Regulatory Issues.
520 $a 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 $a Statistics . $3 1253516
650 0 $a Public health. $3 560998
650 0 $a Epidemiology. $3 635923
650 0 $a Cancer research. $3 1253664
650 0 $a Oncology . $3 1253469
650 1 4 $a Statistics for Life Sciences, Medicine, Health Sciences. $3 670172
650 2 4 $a Public Health. $3 592982
650 2 4 $a Cancer Research. $3 668358
650 2 4 $a Oncology. $3 593951
700 1 $a Furberg, Curt D. $e author. $4 aut $4 http://id.loc.gov/vocabulary/relators/aut $3 1253726
700 1 $a DeMets, David L. $e author. $4 aut $4 http://id.loc.gov/vocabulary/relators/aut $3 1253727
700 1 $a Reboussin, David M. $e author. $4 aut $4 http://id.loc.gov/vocabulary/relators/aut $3 1253728
700 1 $a Granger, Christopher B. $e author. $4 aut $4 http://id.loc.gov/vocabulary/relators/aut $3 1253729
710 2 $a SpringerLink (Online service) $3 593884
773 0 $t Springer Nature eBook
776 0 8 $i Printed edition: $z 9783319185385
776 0 8 $i Printed edition: $z 9783319185408
776 0 8 $i Printed edition: $z 9783319307732
856 4 0 $u https://doi.org/10.1007/978-3-319-18539-2
912 $a ZDB-2-SMA
912 $a ZDB-2-SXMS
950 $a Mathematics and Statistics (SpringerNature-11649)
950 $a Mathematics and Statistics (R0) (SpringerNature-43713)