Influence of Clinical Trials on the Treatment of Diabetes Mellitus

Abstract

The shift from empiricism and observational studies to experimental methods as the basis for advancing the treatment of human disease has occurred only recently. The modern age of clinical trials, born with the British Medical Research Council’s study of streptomycin treatment of tuberculosis in 1948, has provided the substrate for evidence-based medicine. Clinical trials have been credited with “three of the seven years of increased life expectancy over that time and an average of five additional years of partial or complete relief from the poor quality of life associated with chronic disease”. The enormous expansion of clinical trials has paralleled the event of latest therapies. With the massive number of medicine in development and therefore the requirement for controlled clinical trials for approval, the expanding number of clinical trials isn't expected. Despite the obvious benefits of bringing scientific methods to the evaluation of therapies, the need for clinical trials has recently been challenged. Proponents of epidemiological studies as substitutes for clinical trials have suggested that conclusions from observational studies, including meta-analyses, often give similar answers as clinical trials. Although empirical data may provide useful information regarding established therapies, it should be obvious that they play a very different role from clinical trials.