The Resource Fundamentals of Clinical Trials, by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger, (electronic resource)

Fundamentals of Clinical Trials, by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger, (electronic resource)

Label
Fundamentals of Clinical Trials
Title
Fundamentals of Clinical Trials
Statement of responsibility
by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
Creator
Contributor
Author
Author
Subject
Language
  • eng
  • eng
Summary
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.
http://library.link/vocab/creatorName
Friedman, Lawrence M
Dewey number
519.5
http://bibfra.me/vocab/relation/httpidlocgovvocabularyrelatorsaut
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  • iSGt4WSVFSU
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  • Gjv_emPTZuY
Image bit depth
0
Language note
English
LC call number
QA276-280
Literary form
non fiction
http://library.link/vocab/relatedWorkOrContributorName
  • Furberg, Curt D.
  • DeMets, David L.
  • Reboussin, David M.
  • Granger, Christopher B.
http://library.link/vocab/subjectName
  • Statistics
  • Epidemiology
  • Oncology
  • Oncology
  • Statistics for Life Sciences, Medicine, Health Sciences
  • Public Health
  • Epidemiology
  • Cancer Research
  • Oncology
Label
Fundamentals of Clinical Trials, by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger, (electronic resource)
Instantiates
Publication
Note
Bibliographic Level Mode of Issuance: Monograph
Antecedent source
mixed
Carrier category
online resource
Carrier category code
cr
Color
not applicable
Content category
text
Content type code
txt
Contents
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
Dimensions
unknown
Edition
5th ed. 2015.
Extent
1 online resource (XXI, 550 p. 49 illus., 7 illus. in color.)
File format
multiple file formats
Form of item
online
Isbn
9783319185392
Level of compression
uncompressed
Media category
computer
Media type code
c
Other control number
10.1007/978-3-319-18539-2
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
  • (CKB)3710000000467523
  • (SSID)ssj0001558523
  • (PQKBManifestationID)16183692
  • (PQKBTitleCode)TC0001558523
  • (PQKBWorkID)14819058
  • (PQKB)10396498
  • (DE-He213)978-3-319-18539-2
  • (EXLCZ)993710000000467523
Label
Fundamentals of Clinical Trials, by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger, (electronic resource)
Publication
Note
Bibliographic Level Mode of Issuance: Monograph
Antecedent source
mixed
Carrier category
online resource
Carrier category code
cr
Color
not applicable
Content category
text
Content type code
txt
Contents
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
Dimensions
unknown
Edition
5th ed. 2015.
Extent
1 online resource (XXI, 550 p. 49 illus., 7 illus. in color.)
File format
multiple file formats
Form of item
online
Isbn
9783319185392
Level of compression
uncompressed
Media category
computer
Media type code
c
Other control number
10.1007/978-3-319-18539-2
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
  • (CKB)3710000000467523
  • (SSID)ssj0001558523
  • (PQKBManifestationID)16183692
  • (PQKBTitleCode)TC0001558523
  • (PQKBWorkID)14819058
  • (PQKB)10396498
  • (DE-He213)978-3-319-18539-2
  • (EXLCZ)993710000000467523

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