Fundamentals of clinical trials:
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Cham [u.a.]
Springer
2015
|
| Ausgabe: | 5. ed. |
| Schlagworte: | |
| Online-Zugang: | BTU01 FRO01 TUM01 UBM01 UBT01 UBW01 UPA01 Volltext Inhaltsverzeichnis Abstract |
| Beschreibung: | 1 Online-Ressource (XXI, 550 S.) 49 illus., 7 illus. in color |
| ISBN: | 9783319185392 |
| DOI: | 10.1007/978-3-319-18539-2 |
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Datensatz im Suchindex
| _version_ | 1804175020541345792 |
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| adam_text | FUNDAMENTALS OF CLINICAL TRIALS
/ FRIEDMAN, LAWRENCE M.
: 2015
TABLE OF CONTENTS / INHALTSVERZEICHNIS
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
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
FUNDAMENTALS OF CLINICAL TRIALS
/ FRIEDMAN, LAWRENCE M.
: 2015
ABSTRACT / INHALTSTEXT
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.
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
|
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| subject_GND | (DE-588)4031192-2 |
| title | Fundamentals of clinical trials |
| title_auth | Fundamentals of clinical trials |
| title_exact_search | Fundamentals of clinical trials |
| title_full | Fundamentals of clinical trials Lawrence M. Friedman ... |
| title_fullStr | Fundamentals of clinical trials Lawrence M. Friedman ... |
| title_full_unstemmed | Fundamentals of clinical trials Lawrence M. Friedman ... |
| title_short | Fundamentals of clinical trials |
| title_sort | fundamentals of clinical trials |
| topic | Statistics Oncology Public health Epidemiology Statistics for Life Sciences, Medicine, Health Sciences Public Health Cancer Research Statistik Klinische Prüfung (DE-588)4031192-2 gnd |
| topic_facet | Statistics Oncology Public health Epidemiology Statistics for Life Sciences, Medicine, Health Sciences Public Health Cancer Research Statistik Klinische Prüfung |
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