What is the Clinical Trial?
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No drug is a drug until it is proven safe and effective (safety first-emphasis added). All the modern day drugs have been approved by the government authority after a series of clinical trials. The technical core of clinical trial methodology is statistics. So the answer to “What is the clinical trial?”is “a statistically valid medical inference making process for medicine.”
Abstract
No drug is a drug until it is proven safe and effective (safety first-emphasis added). All the modern day drugs have been approved by the government authority after a series of clinical trials. The technical core of clinical trial methodology is statistics. So the answer to “What is the clinical trial?”is “a statistically valid medical inference making process for medicine.”
참고문헌 (9)
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- Friedman LM, "Fundamentals of Clinical Trials, Third edition" (1998), Springer-Verlag
- "Declaration of Helsinki: Recommendation for conduct of clinical research"[URL]
- Lachin JM, "Statistical considerations in the intent-to-treat principle", Controlled Clinical Trials, 21, pp.167~189 (2000)
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- Simrat H, "FDA approval of Bi-Dil: First step to pharmacogenomics or detour intro race-based medicine", Health Law Review, 16(4), pp.34~35 (2008)
- "The Washington Post, December 4", ~ (2006)
- 식품의약품안전청 생물의약품국, "후발생물의 약품평가가이드라인(안)", ~