Fundamentals of Clinical Trials (Google eBook)
The randomized control clinical trial has become the gold standard scientific method for the evaluation of pharmaceuticals, biologics, devices, procedures and diagnostic tests. This trial design has been successfully used in both therapeutic and disease prevention trials. It is superior to alternative designs by eliminating several sources of bias which exist in those designs. This role has evolved over the past three decades in a number of disease areas including cardiology, opthalmology, cancer and AIDS. While the specifics of using the randomized control design for a specific intervention and disease may differ, the basic fundamentals still apply in developing the study protocol and operational procedures. These fundamentals still apply in developing the study protocol and operational procedures. These fundamentals include identifying the specific questions to be tested and appropriate outcome measures, determining an adequate sample size, specifying the randomization procedure, detailing the intervention with visit schedules for subject evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and determining the organizational structure. This text is structured to address the fundamentals as the protocol for a clinical trial is being developed. A chapter is devoted to each of the critical areas of a protocol to aid the clinical trial researcher. The fundamentals described in this text are based on sound scientific methodology, statistical principles and years of accumulated experience by the three authors. Collectively, the authors have been active researchers in a broad area of clinical trials including cardiology, cancer, opthalmology, diabetes, osteoporosis, AIDS, women's health and screening tests. In these studies, the authors have served as members of the steering committee responsible for developing the protocol and as members of data and safety monitoring committees. The fundamentals were proposed in the first edition published in 1981 and have not changed substantially in the later editions. However, the number of examples illustrating the fundamentals has greatly expanded base on the collective experience of the authors. This text 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 test uses numerous examples of published clinical trials from a variety of medical disciples to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity. The text assumes that the readers have only a modest formal statistical background. A basic introductory statistics course is helpful in maximizing the benefit of the text. However, a researcher or practitioner with no statistical background would still find most, if not all the chapters understandable and useful.
What Is the Question?
Basic Study Design
The Randomization Process 6 1
Assessment of HealthRelated Quality of Life
Monitoring Response Variables
Issues in Data Analysis
Reporting and Interpreting of Results
Sample Size Tables for Clinical Studies, Second Edition
David Machin,Mj Campbell,PM Fayers,Apy Pinol
No preview available - 1997
JSTOR: Fundamentals of Clinical Trials. (2nd ed.).
358 Journal of the American Statistical Association, March 1987 Fundamentals of Clinical Trials (2nd ed.). Lawrence M. Friedman, Curt D. Furberg, ...
Fundamentals of Clinical Trials - Statistics for Life Sciences ...
Fundamentals of Clinical Trials - Life Sciences, Medicine & Health. The randomized control clinical trial has become the gold standard scientific method for ...
www.springer.com/ statistics/ stats+life+sci/ book/ 978-0-387-98586-2
American Journal of Physical Medicine & Rehabilitation - Fulltext ...
Fundamentals of Clinical Trials for Medical Rehabilitation .... Friedman LM, Furberg CD, demets DL:Fundamentals of Clinical Trials, ed 2. ...
www.amjphysmedrehab.com/ pt/ re/ ajpmr/ fulltext.00002060-200310001-00005.htm;jsessionid=GRJpKpFJQhsBnGbc1Cty1vCVbLG0pdY...
biomedical Engineering online | Comments | Review of "Fundamentals ...
Review of "Fundamentals of Clinical Trials" by LM. Friedman, CD. Furberg and DL. demets. Max E Valentinuzzi email. biomedical Engineering online 2004, ...
www.biomedical-engineering-online.com/ content/ 3/ 1/ 43/ comments
The Randomization Process: Fundamentals of Clinical Trials
1.000 Fundamentals of Clinical Trials, ed 2 Littleton, MA ... 1.000 In Fundamentals of Clinical Trials (Eds Pp. 83 106 (Chapter 6) ...
EXPERIMENTAL DESIGN SUGGESTED BOOKS Planning of Experiments Cox ...
Fundamentals of Clinical Trials. Friedman, Furberg and De Mets. Springer. The Design of Experiments. Fisher. Oliver and Boyd ...
stats.ma.ic.ac.uk/ ~lvw/ M3S10_M4S10/ s10books.pdf
1475-925X-3-43 1475-925X Book review Review of "Fundamentals of ...
Book details Friedman ml Furberg dc demets ld Fundamentals of Clinical Trials Springer-Verlag, New York 3 1998 361 pp, ISBN 0-387-98586-7 Clinical Research ...
www.biomedcentral.com/ content/ download/ xml/ 1475-925x-3-43.xml
CORE Randomized Clinical Trials Outcome Resources Page
Fundamentals of clinical trials (Third ed.). New York: Springer-Verlag New York Inc. Ginsberg, D. (1999). The investigator's guide to clinical research (2nd ...
www.uic.edu/ ahs/ OT/ CORE/ trial.htm
sciencedirect - The American Journal of Surgery : Clinical research
The book “Fundamentals of Clinical Trials” by Friedman et al  is an excellent resource and is used in the ACS Clinical Trials course. ...
linkinghub.elsevier.com/ retrieve/ pii/ S0002961006003163
UW Madison Statistics Course 542, Dr. demets
Required - Fundamentals of Clinical Trials by Friedman, Furberg and demets, Springer-Verlag, New York, NY, 3rd edition, 1998; Required - Randomized Clinical ...
www.medsch.wisc.edu/ biostat/ Courses/ biostat542.htm