Using examples and case studies from industry, academia andresearch literature, Randomized Clinical Trials provides adetailed overview of the key issues involved in designing,conducting, analysing and reporting randomized clinicaltrials. It examines the methodology for conducting Phase IIIclinical trials, developing the protocols, the practice forcapturing, measuring, and analysing the resulting clinical data andtheir subsequent reporting.
Randomized clinical trials are the principal method fordetermining the relative efficacy and safety of alternativetreatments, interventions or medical devices. They areconducted by groups comprising one or more of pharmaceutical andallied health-care organisations, academic institutions, andcharity supported research groups. In many cases such trialsprovide the key evidence necessary for the regulatory approval of anew product for future patient use. Randomized ClinicalTrials provides comprehensive coverage of such trials, rangingfrom elementary to advanced level.
Written by authors with considerable experience of clinicaltrials, Randomized Clinical Trials is an authoritative guidefor clinicians, nurses, data managers and medical statisticiansinvolved in clinical trials research and for health careprofessionals directly involved in patient care in a clinical trialcontext.
David Machin
Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin
"Randomized Clinical Trials: Design, Practice and Reportingis a solid introduction for clinical research investigators."(The Journal of Clinical Research Best Practices, February2011)
"In summary, this text is ambitious in its scope (possibly to afault), but certainly fills a void in the literature in the sensethat it provides a comprehensive overview of the planning,execution, and reporting of clinical trials that is unparalleled."(Journal of Biopharmaceutical Statistics (JBS), February2011)
"Randomized Clinical Trials aims to bring bang up to dateall the recent major developments in the important field ofclinical trial methodology and statistics. A supremely importantsubject to all of us, this is surely a more worthy new yearinvestment than that month's supply of dandelion liver flushtonic." (Health Writer, Autumn 2009)
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