临床试验於研究设计与计画撰写方面之法规科学考量.pptVIP

Active Control 要選擇 current standard therapy。 Trial 可採 superiority, non-inferiority 或 equivalence design。 亦可以由 non-inferiority 成功後，再測試 superiority。 有時 active control 僅作為 assay sensitivity 之用 (主要療效假說仍是 test product 優於 placebo，例如 3-arm design)。 參考資料: www.ema.europa.eu/pdfs/human/ewp/215899en.pdf www.ema.europa.eu/pdfs/human/ewp/048299en.pdf /downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf * When to Break The Code? Randomization procedures must be followed to ensure that the treatment code is only able to be broken in the event of any of the following occurrences (u