A clinical trial is a research study to determine if experimental treatments are safe and effective under controlled conditions. This type of study involves both human and animal subjects and is an important step in identifying treatments that can be approved by regulatory agencies for widespread use.
Clinical Research Organizations with treatments that have satisfactory safety results and positive pharmacological findings can proceed to the clinical trial stage. The clinical trial stage is generally considered the most important stage in the course of treatment development and assessment.
Of the thousands of isolated or synthesized chemical compounds that show promise in preclinical studies, a large percentage aren’t successful in the clinical trials stage. The unsuccessful chemical compounds are either extremely poisonous, too challenging or expensive to produce on a large scale, or offer too few benefits. Chemicals and biologics that appear to have some potential in preclinical studies next must be tested among human volunteers and in high-risk populations. Of the thousands of drugs tested in clinical trials, only 1 in 20 compounds will pass the rigorous and challenging FDA approval process. This process requires detailed reporting of study populations and findings.
Translation of Clinical Trial Reports
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