Randomized Clinical Trials: Design, Practice and Reporting

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.