Clinical trials are research studies designed to answer a specific question which would then serve to improve current medical care. These studies focus on which medical treatment works best for a specific population of people with a certain disease. Usually a clinical trial is developed after there is some pre-clinical success or promising results in studies done in the laboratory.
Clinical trials are usually categorized as phase I, phase II or phase III. Phase I studies are done very early in drug development and usually focus on patient safety and trying to find the right dose that is tolerable. Later-phase studies tend to be more disease-specific and may compare an investigational treatment approach to the standard of care to see if there is any benefit with the new treatment.
Each clinical trial has its own inclusion and exclusion criteria. This helps make sure there is uniformity within the trial and that there are no outside factors which could influence the outcome of the study. Clinical trials help improve medical care and are necessary when seeking FDA approval for use within the general population.
Clinical trials are usually categorized as phase I, phase II or phase III. Phase I studies are done very early in drug development and usually focus on patient safety and trying to find the right dose that is tolerable. Later-phase studies tend to be more disease-specific and may compare an investigational treatment approach to the standard of care to see if there is any benefit with the new treatment.
Each clinical trial has its own inclusion and exclusion criteria. This helps make sure there is uniformity within the trial and that there are no outside factors which could influence the outcome of the study. Clinical trials help improve medical care and are necessary when seeking FDA approval for use within the general population.
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Clinical Trial Risks
Clinical Trial Risks
Source: wtop.com
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