By Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
This is the fourth variation of a really profitable textbook on medical trials method, written by way of 3 well-known specialists who've lengthy and huge adventure in all parts of scientific trials. so much chapters were revised significantly from the 3rd variation. A bankruptcy on ethics has been additional and issues reminiscent of noninferiority and adaptive designs now obtain substantial dialogue. there's a lot new fabric on adversarial occasions, adherence, info tracking, and concerns in research. This e-book is meant for the medical researcher who's drawn to designing a medical trial and constructing a protocol. it's also of price to researchers and practitioners who needs to severely assessment the literature of released medical trials and investigate the advantages of every trial and the results for the care and therapy of sufferers. The authors use a variety of examples of released scientific trials from a number of scientific disciplines to demonstrate the basics. The textual content is prepared sequentially from defining the query to trial closeout. One bankruptcy is dedicated to every of the serious parts to assist the scientific trial researcher. those parts contain pre-specifying the clinical inquiries to be verified and acceptable consequence measures, picking out the organizational constitution, estimating an enough pattern measurement, specifying the randomization method, enforcing the intervention and stopover at schedules for player evaluate, developing an period in-between facts and security tracking plan, detailing the ultimate research plan, and reporting the trial effects in accordance with the pre-specified ambitions. even though a simple introductory information direction is useful in maximizing the advantage of this ebook, a researcher or practitioner with constrained statistical heritage might nonetheless locate so much if now not all of the chapters comprehensible and invaluable. whereas the technical fabric has been saved to a minimal, the statistician should still locate the rules and basics provided during this textual content beneficial. This booklet has been effectively used for educating classes in medical trial methodology.
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Additional resources for Fundamentals of Clinical Trials
Not all questions need to be answered, and not all of those that should be answered require clinical trials. Sometimes, other kinds of clinical studies may be able to address the question at least as well as, or even better than, a clinical trial. Even if the answer may not be quite as good, the added benefits from the trial may not be worth the added risk. Because clinical trials involve administering something (drug, device, biologic, or procedure) to someone, or attempting to change someone’s behavior, there may be adverse as well as the hoped-for positive results.
Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002;288:321–333. 93. The Women’s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. JAMA 2004;291:1701–1712. 94. Furberg BD, Furberg CD. Evaluating Clinical Research: All that Glitters is not Gold. ). New York: Springer, 2007. 95. Chalmers TC. Randomization of the first patient. Med Clin North Am 1975;59:1035–1038.
An early decision relates to whether a clinical trial is even necessary. Not all questions need to be answered, and not all of those that should be answered require clinical trials. Sometimes, other kinds of clinical studies may be able to address the question at least as well as, or even better than, a clinical trial. Even if the answer may not be quite as good, the added benefits from the trial may not be worth the added risk. Because clinical trials involve administering something (drug, device, biologic, or procedure) to someone, or attempting to change someone’s behavior, there may be adverse as well as the hoped-for positive results.
Fundamentals of Clinical Trials by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger