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KMID : 1155220110360010001
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Journal of the Korean Society of Health Information and Health Statistics
2011 Volume.36 No. 1 p.1 ~ p.14
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What is the Clinical Trial?
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Lee Young-Jack
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Abstract
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No drug is a drug until it is proven safe and effective (safety first-emphasis added). All drugs in these days have been approved by government authority after a series of clinical trials. Today, clinical trials have begun in Korea only recently. Nevertheless Korea is fast becoming a popular destination for multinational clinical trials. Korea Food and Drug Administration has defined that clinical trial is any investigation in human subjects to study effects of investigational products. Clinical trial is a process that must strictly abide by rules, regulations and study plans. Clinical trial of new drug candidate has very high chance of failure and thus is very difficult. Finally, clinical trial is scientific experiment within frame of ethics and respect for human rights. Technical core of this last point is statistical principles of minimizing bias and design of experiment. Final product of clinical trials is statistical inference about effects of investigational products in
human body. So, answer to “What is the clinical trial?” is “a statistically valid medical inferencemaking process for medicine.”
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KEYWORD
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Clinical trial, Statistical principles, Design of experiment, Clinical research
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