By John F. Kurtzke (auth.), Roger J. Porter, Bruce S. Schoenberg (eds.)
The evaluate of the efficacy and safeguard of a scientific software, be it a diagnostic strategy, a preventive technique, or a healing intervention, is an im portant accountability of physicians. The background of medication is characterised via the authoritarianisms of lecturers and of agencies giving option to the scientific adventure of physicians; authoritarian dictum was once changed by way of case file after which by way of case sequence. As physicians discovered to alternative the research of knowledge for the inconsistencies of dictums and anecdotes, the issues of the case sequence as an investigative instrument grew to become extra obvious: sufferer choice standards, measurements of consequence, importance of effects, and extrapolation of conclusions to the neighborhood of sufferers. based on those concerns, the method of the managed scientific trial has advanced and with it the instru ments of research layout and of biostatistics as aids to review layout and knowledge research. The clinical - surgical armamentarium has developed from being established exclusively upon the observations and conclusions of a talented clinician to being developed upon the systematic assortment and evaluate of knowledge by means of a group of expert clinicians and their statistical colleagues: this is often the managed medical trial. up to now 20 years, the assessment of medical ways to pre vention and remedy has develop into relatively very important to clinicians concerned about anxious procedure disorder. there was and is still an explosion of knowledge from the fundamental neurosciences and from the applica tion of biotechnology to the anxious system.
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Extra info for Controlled Clinical Trials in Neurological Disease
2. DESIGN CONSIDERATIONS Many statistical design considerations exist. One must understand and integrate them into the clinical science of neurological diseases before a controlled clinical trial should be undertaken. In the last five years, several textbooks have 20 I. Design of Clinical Trials CI iniccl RelevalCS Spec I ficllbj +1 Senslllvllbj Reeponse erd-pa I nl A +,. +1 Reapanaa erd-pa I nl B Figure 2-2. Braycentric coordinates are illustrated for five descriptors of response endpoints. Each of the axes illustrates the relative importance of each descriptor measured on a scale from 0 to 1 with 1 indicating the maximum for that axis.
However, efficacy alone is often an insufficient criterion for determining response endpoints that accurately assess the benefit of a new drug therapy. In many neurologic diseases, as in other chronic disorders, quality-of-life assessments are being used, not only to strengthen the evidence for approval of new agents, but to determine the position of new therapies in the marketplace. All the variables discussed above must be weighed in the planning of a clinical trial. The process of choosing response end-points must give consideration to the statistical methods and assumptions needed to maximize the power of the trial to detect a drug effect.
Full-scale phase III randomized clinical trials (RCTs) are best presented as journal supplements that include the full trial protocol, the data forms, and detailed tabular results. In assessing treatment trials, the clinician most needs to know the selection criteria, the treatment regimen, and the treatment results. Only with the gold standard - the true randomized, double-blind, placebo-controlled, therapeutic trial- can the results be attributed confidently to the treatment itself. Lack of blinding and placebo, even in a properly randomized trial, permits only a judgment as to whether the total test regimen including the specific therapy differs from another regimen without that therapy.