Fundamentals of Clinical Trials
(Sprache: Englisch)
This standard reference discusses general as well as specific issues involved in the development, management, and analysis of clinical trials. It serves to update areas in which considerable progress has recently been made, and to broaden the scope in the...
Leider schon ausverkauft
versandkostenfrei
Buch
56.66 €
Produktdetails
Produktinformationen zu „Fundamentals of Clinical Trials “
This standard reference discusses general as well as specific issues involved in the development, management, and analysis of clinical trials. It serves to update areas in which considerable progress has recently been made, and to broaden the scope in the light of clinical trials in new areas. The text will assist investigators in academia and industry in improving the quality of clinical trials by discussing fundamental concepts for those with some clinical trial experience as well as for those who plan to conduct a trial for the first time. It may also be used as a textbook in the teaching of clinical trial methodology and to assist members of the scientific and medical community who wish to evaluate and interpret published reports of trials. Although not a technically oriented text, it may equally be used as a reference for a graduate course on statistical methods in clinical trials.
Klappentext zu „Fundamentals of Clinical Trials “
The clinical trial is "the most definitive tool for evaluation of the applicability of clinical research." It represents "a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments" [1]. It has been called on many occasions, "the gold st- dard" against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2-21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.
This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis.
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 from a variety of medical disciplines 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.
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 from a variety of medical disciplines 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.
Inhaltsverzeichnis zu „Fundamentals of Clinical Trials “
- Introduction to clinical trials- Ethical issues
- What is the question?- Study population
- Basic study design
- The randomization process
- Blindness
- Sample size
- Baseline assessment
- Recruitment of study participants
- Data collection and quality control
- Assessing and reporting adverse effects
- Assessment of health-related quality of life
- Participant adherence
- Survival analysis
- Monitoring response variables
- Issues in data analysis
- Closeout
- Reporting and interpreting of results
- Multicenter trials
Bibliographische Angaben
- Autoren: Lawrence M. Friedman , Curt D. Furberg , David L. DeMets
- 2010, 4th ed., 445 Seiten, Maße: 15,4 x 23,6 cm, Kartoniert (TB), Englisch
- Verlag: Springer
- ISBN-10: 1441915850
- ISBN-13: 9781441915856
Sprache:
Englisch
Rezension zu „Fundamentals of Clinical Trials “
From the reviews of the fourth edition:"This book is clearly written for students in the arena of health care. Physicians and health care providers can use it as a reference book. ... The organization and structure is good and logical. ... it deepens the understanding of applications of statistical methods and the analysis of clinical trials. Also, it provides a list of references at the end of each chapter. ... In summary, this is an important contribution, providing up-to-date coverage on clinical trial methodology in a logical and systematic manner." (Technometrics, Vol. 53 (2), May, 2011)
Kommentar zu "Fundamentals of Clinical Trials"
0 Gebrauchte Artikel zu „Fundamentals of Clinical Trials“
Zustand | Preis | Porto | Zahlung | Verkäufer | Rating |
---|
Schreiben Sie einen Kommentar zu "Fundamentals of Clinical Trials".
Kommentar verfassen