Field Notes/Core Notes : ์‹ ์•ฝ๊ฐœ๋ฐœ
์ž„์ƒ์‹œํ—˜ ๋Œ€์ƒ๊ตฐ ๋ถ„์„๋ฐฉ๋ฒ•, ์ž„์ƒ๊ฒฐ๊ณผ, ๋ถ€์ž‘์šฉ์˜ ๋ฒ”์ฃผ
2022.12.26
์ž„์ƒ์‹œํ—˜ ๋Œ€์ƒ๊ตฐ ๋ถ„์„ -ICH E9 guideline -> ITT, Intention to treat ๊ธฐ๋ณธ (1) FAS, Full analysis set: ์ฃผ์š” ๊ธฐ์ค€ ์œ„๋ฐฐํ–ˆ๊ฑฐ๋‚˜ ํ•œ๋ฒˆ๋„ ํˆฌ์—ฌํ•˜์ง€ ์•Š์•˜์„ ๋•Œ, ์ž๋ฃŒ ์—†์„ ๋•Œ ์ œ์™ธ (2) PPS: Per-protocol set: FAS ์ค‘์— ๊ธฐ์ค€ ์ถฉ์กฑํ•˜๋Š” ์ผ๋ถ€ ๊ตฐ (3) ์•ˆ์ „์„ฑ๊ตฐ: Safety set: ์ฒ˜์น˜ ๋ฐ›์€ ๋ชจ๋“  ์‚ฌ๋žŒ ์ž„์ƒ๊ฒฐ๊ณผ -CR: ์™„์ „๊ด€ํ•ด, ์—†์–ด์ง -PR: ๋ถ€๋ถ„๊ด€ํ•ด, 30%์ด์ƒ ์ž‘์•„์ง => ๋‘˜ ํ•ฉ์ณ์„œ ORR, ๊ฐ๊ด€์  ๋ฐ˜์‘๋ฅ , ์ •์˜๋œ ์–‘ ์ด์ƒ์˜ ๊ฐ์†Œ๋ฅผ ๋ณด์ธ ํ™˜์ž ๋น„์œจ -SD: ์•ˆ์ •๋ณ‘๋ณ€, 30%๋ฏธ๋งŒ ๊ฐ์†Œ or 20%๋ฏธ๋งŒ ์ปค์ง => CR, PR์— ๋”ํ•ด DCR, ์งˆ๋ณ‘์กฐ์ ˆ์œจ -PD: ์ง„ํ–‰๋ณ‘๋ณ€, 20%์ด์ƒ ์ปค์ง -Survival Rate -Overal Sur..