Controlled clinical trial elements

Within the last 20 years or so, three major features of controlled clinical trials, in particular, have permitted significant advances in deciding whether treatments are of value or not randomisation, systematic review and metaanalysis, and the concept of the large-scale, simple (to understand and conduct) randomised trial in areas where only moderate benefits can be expected.All of these elements are likely to underpin future trials for purposes of regulation, pharmacoeconomics and healthcare policy. Yet there is no room for complacency or allowing standards to slip. Systematic reviews of some... 

The Controlled Clinical Trial basic design elements... 

THE CONTROLLED CLINICAL TRIAL BASIC DESIGN ELEMENTS... 

The controlled clinical trial (CCT) is the scientific tool for demonstrating causality. Two essential elements characterize the CCT (a) it contains a control group and an experimental group (b) with the exception of treatment, all other conditions and procedures to which the subjects are exposed during the trial are constant. These two characteristics of the CCT enable the researcher to establish a causal relationship between treatment and the outcome of the trial. The tool for standardizing the trial is the study protocol, the document defining the subjects eligible for inclusion in the study, the study procedures and schedules. 

The key elements of an inspection are to ensure that the facility is capable of fulfilling the application commitments to manufacture, process, control, package, and label a drug product following GMP the adequacy and accuracy of analytical methods submitted, to ensure that these methods are proper for the testing proposed correlation between the manufacturing process for clinical trial material, bioavailability study material, and stability studies and submitted process that the scientific data support full-scale production procedures and controls that only factual data have been submitted and that the protocols are in place to validate the manufacturing process. 

Add-on trial. A trial in which an experimental treatment is compared with a control treatment (often a placebo) in the presence of at least one other treatment. So, for example, one might compare a bronchodllator with placebo in a group of patients all of whom are receiving steroids. From one point of view all conventional clinical trials are add-on trials is some sense, since all patients will receive some element of standard care even if this only consists of nursing care, food, drink, etc. 

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