... an
Textbook ofClinical Trials. Edited by D. Machin, S. Day and S. Green
2004 John Wiley & Sons, Ltd ISBN: 0-471-98787-5
Preface
This TextbookofClinicalTrials is not a textbook
ofclinical ... would then, in
principle, be set aside and excluded from the
trial results.
Textbook ofClinicalTrials
Textbook ofClinical Trials. Edited by D. Machin, S. Day and S. Green
2004 John Wiley & ... used in the analysis ofclinical trials.
These include in, for example, cancer clinical
trials with dual endpoints of tumour response
and overall survival, the analysis of survival by
tumour...
... feature ofclinicaltrials is that they are designed to answer
a single question, but we humans force them to answer hundreds. is is the source of both
their power and their debility.
e value ofclinical ... double-blind trials employ drugs only, with-
outplacebo.Manyrandomizedstudies,however,areperfectlyvalidwithouttheuseofany
placebo. us, placebos are not the sine qua non ofclinical trials: randomization ... in prevention of depressive episodes (one of the frequently emphasized
secondary outcomes) (Goodwin et al., 2004).
Another example of the issue of generalizability involves studies of combination...
... for children in clinical investigation of FDA-regulated
products
13
FDA US
22 2004
Textbook ofclinical trials, chapter: clinicaltrials in pediatrics
8
Karlberg UK
Survey of current guidance ... monitor the level of risk of a study and
to give advice about early stopping ofclinical trials.
23;51
Practical issues
Only three guidelines addressed practical issues ofclinicaltrials in children.
8;59;61
... consisted of recommendations for the design, conduct or reporting of
clinical trials in children. In addition, three actual guidelines on the design, conduct or
reporting ofclinicaltrials in...
... T. Blei MD
Professor of Medicine and Surgery, Northwestern University
Feinberg School of Medicine, Chicago, IL, USA
Jürg Reichen MD
Professor of Medicine, University of Bern; Chief of Hepatology,
University ... Friedman MD
Fishberg Professor of Medicine, Chief, Division of Liver Diseases,
Mount Sinai School of Medicine, New York, NY, USA
Pere Ginès MD
Professor of Medicine, University of Barcelona, Chief, ... Wolkoff MD
Professor, Department of Medicine
Albert Einstein College of Medicine
Bronx, NY, USA
John B. Wong MD
Chief, Division ofClinical Decision Making
Tufts-New England Medical Center;
Professor...
... expansion
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... Department of Orthopaedic Surgery, University of
Minnesota, MN , USA
Juhani Leppäluoto Department of Physiology, University of Oulo, FIN-, Finland
Ingard Lerein Department of Orthopaedic ... in the promotion of health and prevention of life-style dis-
eases in individuals of all ages. Furthermore, lately the medical field has gained improved understanding of the use
of physical activity...
... role of endoscopy in the
evaluation of iron deficiency anemia in patients over the age of
50. Am J Gastroenterol. 1994; 89: 1963–7.
23. Fireman Z, Gurevich V, Coscas D, et al. Results of gastrointes-
tinal ... The absence of stainable iron is the “gold
standard”, for diagnosis of IDA. Marrow examination
shows, in addition to the absence of hemosiderin iron,
a decrease in the proportion of sideroblasts, ...
cause of IDA in developing countries is still nutri-
tional deficiency. In some instances, an insufficient
supply of iron may contribute to the development of
iron deficiency. The consumption of...