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Textbook of Clinical Trials |
| Editor: Simon Day (Medicine and Healthcare Products Regulatory Agency, UK); Editor: Sylvan Green (Arizona Cancer Center, USA); Editor: David Machin (National Cancer Centre, Singapore ) |
| This comprehensive volume on clinical trials covers all important disease and therapeutic areas together with methodologies, phase I/II/III studies and other issues. It is the first book to deal with all important diseases and is an essential reference for all involved with clinical trials. This Textbook of Clinical Trials is not a textbook of clinical trials in the traditional sense. Rather, it catalogues in part both the impact of clinical trials (particularly the randomised controlled trial) on the practice of medicine and allied fields and on the developments and practice of medical statistics. The latter has evolved in many ways through the direct needs of clinical trials and the consequent interaction of statistical and clinical disciplines. The impact of the results from clinical trials (particularly the randomised controlled trial), on the practice of clinical medicine and other areas of health care has been profound. Probably the single most important contribution to the science of comparative clinical trials was the recognition, more than 50 years ago, that patients should be allocated to the options under consideration at random. This was the foundation for the science of clinical trial research and placed the medical statistician at the centre of the process. Although the medical statistician may be at the centre, he or she is by no means alone. Indeed the very nature of clinical trial research is multidisciplinary in nature so that a âÂÂteamâ effort is always needed from the concept stage, through design, conduct, monitoring and reporting. Clinical trials imply some intervention affecting the subjects who are ultimately recruited into them. Each group studied in a clinical trial, from unborn child to aged adult, brings its own constraint on the ultimate design of the trial in mind. So too does the relative efficacy of the current standard. If the outcome is death and the prognosis poor, then bolder steps may be taken in the choice of treatments to test. If the disease is self-limiting or the outcome cosmetic then a more conservative approach to treatment options would be justified. In all this activity the choice of clinical trial design and its ultimate conduct are governed by essential ethical constraints, the willingness of subjects to consent to the trial in question and their right to withdraw from the trial should they wish. Thus the Textbook of Clinical Trials, addresses some of these and many other issues as they impact on patients with cancer, cardiovascular disease, dermatological, dental, mental and ophthalmic health, gynaecology and respiratory diseases. In addition, chapters deal with issues relating to complementary medicine, contraception and special issues in children and special issues in older patients. A brief history of clinical trials and a summary of some pertinent statistical issues are included.
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| Cloth Bound |
496 Pages
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Item #:
Price: |
0471987875
$270.00 |
John Wiley & Sons, Inc. | |
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