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{"id":749,"date":"2021-09-12T05:39:38","date_gmt":"2021-09-12T05:39:38","guid":{"rendered":"https:\/\/thuonglibrary.com\/?p=749"},"modified":"2021-09-18T09:12:10","modified_gmt":"2021-09-18T09:12:10","slug":"cac-thuat-ngu-can-biet-de-doc-mot-bai-bao-nghien-cuu-khoa-hoc-phan-1","status":"publish","type":"post","link":"https:\/\/thuonglibrary.com\/nghien-cuu-khoa-hoc\/cac-thuat-ngu-can-biet-de-doc-mot-bai-bao-nghien-cuu-khoa-hoc-phan-1\/","title":{"rendered":"31 thu\u1eadt ng\u1eef c\u1ea7n bi\u1ebft \u0111\u1ec3 \u0111\u1ecdc m\u1ed9t b\u00e0i b\u00e1o nghi\u00ean c\u1ee9u khoa h\u1ecdc – Ph\u1ea7n 1"},"content":{"rendered":"\n

Glossary of Clinical Trial Terms<\/em><\/strong><\/h4>\n\n\n\n
Trong nh\u1eefng l\u1ea7n \u0111\u1ea7u khi ti\u1ebfp x\u00fac v\u1edbi nh\u1eefng b\u00e0i b\u00e1o nghi\u00ean c\u1ee9u, m\u00ecnh ph\u1ea3i m\u1ea5t h\u00e0ng gi\u1edd \u0111\u1ed3ng h\u1ed3 \u0111\u1ec3 v\u1eeba \u0111\u1ecdc, v\u1eeba tra t\u1eeb \u0111i\u1ec3n c\u00e1c thu\u1eadt ng\u1eef n\u00e0y, v\u1eeba t\u00ecm c\u00e1c th\u00f4ng tin \u0111\u1ec3 hi\u1ec3u \u00fd ngh\u0129a c\u1ee7a ch\u00fang. <\/p>\n\n\n\n
Do \u0111\u00f3, hi v\u1ecdng b\u00e0i vi\u1ebft n\u00e0y s\u1ebd ti\u1ebft ki\u1ec7m cho b\u1ea1n th\u1eddi gian \u0111\u1ec3 \u0111\u1ecdc nghi\u00ean c\u1ee9u c\u0169ng nh\u01b0 hi\u1ec3u m\u1ed9t c\u00e1ch r\u00f5 r\u00e0ng t\u1eebng kh\u00e1i ni\u1ec7m qua nh\u1eefng v\u00ed d\u1ee5 minh h\u1ecda \u0111\u01b0\u1ee3c di\u1ec5n gi\u1ea3i theo c\u00e1ch \u0111\u01a1n gi\u1ea3n h\u00f3a nh\u1ea5t. V\u00ec c\u00f3 r\u1ea5t nhi\u1ec1u thu\u1eadt ng\u1eef n\u00ean m\u00ecnh s\u1ebd chia b\u00e0i vi\u1ebft n\u00e0y l\u00e0m 2 ph\u1ea7n. Ph\u1ea7n 1 s\u1ebd bao g\u1ed3m 31 thu\u1eadt ng\u1eef. <\/p>\n\n\n\n
N\u1ebfu b\u1ea1n c\u1ea7n b\u1ea3n word \u0111\u1ec3 tra c\u1ee9u thu\u1eadn ti\u1ec7n, vui l\u00f2ng share b\u00e0i vi\u1ebft t\u1ea1i Fanpage Th\u01b0\u01a1ng Library<\/a> \u1edf ch\u1ebf \u0111\u1ed9 c\u00f4ng khai v\u00e0 g\u1edfi inbox m\u00e0n h\u00ecnh t\u1ea1i Fanpage \u0111\u1ec3 c\u00f3 th\u1ec3 nh\u1eadn \u0111\u01b0\u1ee3c ph\u1ea7n 1 c\u1ee7a b\u00e0i vi\u1ebft. \u0110\u00e2y l\u00e0 c\u00e1ch h\u1ed7 tr\u1ee3 Th\u01b0\u01a1ng Library chia s\u1ebb th\u00eam th\u00f4ng tin t\u1edbi nhi\u1ec1u \u0111\u1ed9c gi\u1ea3 h\u01a1n. <\/p>\n\n\n\n
1. Adverse Event \u2013 Bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd<\/strong><\/h3>\n\n\n\n
M\u1ed9t thay \u0111\u1ed5i ti\u00eau c\u1ef1c ho\u1eb7c s\u1ef1 c\u1ed1 y t\u1ebf x\u1ea3y ra trong qu\u00e1 tr\u00ecnh th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng ho\u1eb7c trong m\u1ed9t kho\u1ea3ng th\u1eddi gian nh\u1ea5t \u0111\u1ecbnh sau khi k\u1ebft th\u00fac th\u1eed nghi\u1ec7m. Bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd \u0111\u00f3 c\u00f3 th\u1ec3 c\u00f3 ho\u1eb7c kh\u00f4ng do ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb \u0111ang \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u g\u00e2y ra^{1<\/sup><\/p>\n\n\n\n}
V\u00ed d\u1ee5:<\/strong> <\/p>\n\n\n\n
B\u1ea1n b\u1ecb nh\u1ee9c \u0111\u1ea7u\/s\u1ed1t sau khi ti\u00eam vaccine Covid-19.<\/p>\n\n\n\n
B\u1ea1n s\u1eed d\u1ee5ng thu\u1ed1c X \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb nh\u1ee9c \u0111\u1ea7u kinh ni\u00ean, sau 2 th\u00e1ng s\u1eed d\u1ee5ng, b\u1ea1n c\u1ea3m th\u1ea5y da h\u1ebft m\u1ee5n. \u0110\u00e2y c\u0169ng \u0111\u01b0\u1ee3c x\u1ebfp v\u00e0o bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i v\u00ec theo nh\u01b0 \u0111\u1ecbnh ngh\u0129a, bi\u1ebfn c\u1ed1 \u0111\u00f3 x\u1ea3y ra \u201cb\u1ea5t th\u01b0\u1eddng\u201d trong qu\u00e1 tr\u00ecnh b\u1ea1n \u0111i\u1ec1u tr\u1ecb v\u1edbi thu\u1ed1c X. Th\u00f4ng th\u01b0\u1eddng, \u1edf c\u00e1c n\u01b0\u1edbc c\u00f3 h\u1ec7 th\u1ed1ng y t\u1ebf ph\u00e1t tri\u1ec3n, ng\u01b0\u1eddi ta s\u1ebd y\u00eau c\u1ea7u b\u1ea1n ghi nh\u1eadn c\u00e1c adverse event \u0111\u1ec3 thu th\u1eadp d\u1eef li\u1ec7u li\u00ean quan \u0111\u1ebfn t\u00ednh an to\u00e0n c\u1ee7a thu\u1ed1c. <\/p>\n\n\n\n
$\"\"$ <\/figure><\/li><\/ul> Bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd \u0111\u00f3 c\u00f3 th\u1ec3 c\u00f3 ho\u1eb7c kh\u00f4ng do ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb \u0111ang \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u g\u00e2y ra^{1<\/sup> <\/figcaption><\/figure>\n\n\n\n}
2. Serious adverse event – S\u1ef1 ki\u1ec7n b\u1ea5t l\u1ee3i nghi\u00eam tr\u1ecdng<\/strong><\/h3>\n\n\n\n
M\u1ed9t s\u1ef1 ki\u1ec7n b\u1ea5t l\u1ee3i \u0111e d\u1ecda \u0111\u1ebfn t\u00ednh m\u1ea1ng, c\u1ea7n ph\u1ea3i nh\u1eadp vi\u1ec7n ho\u1eb7c th\u1eddi gian n\u1eb1m vi\u1ec7n k\u00e9o d\u00e0i, d\u1eabn \u0111\u1ebfn m\u1ea5t kh\u1ea3 n\u0103ng li\u00ean t\u1ee5c ho\u1eb7c \u0111\u00e1ng k\u1ec3, g\u00e2y d\u1ecb t\u1eadt b\u1ea9m sinh, can thi\u1ec7p b\u1eaft bu\u1ed9c \u0111\u1ec3 ng\u0103n ng\u1eeba th\u01b0\u01a1ng t\u1ed5n ho\u1eb7c d\u1eabn \u0111\u1ebfn t\u1eed vong^{2<\/sup><\/p>\n\n\n\n}
V\u00ed d\u1ee5:<\/strong> <\/p>\n\n\n\n
B\u1ea1n c\u00f3 th\u1ec3 tham kh\u1ea3o th\u1ea3m h\u1ecda Thalidomide \u0111\u1ec3 r\u00f5 h\u01a1n v\u1ec1 bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i nghi\u1ec7m tr\u1ecdng. <\/p>\n\n\n\n
https:\/\/cand.com.vn\/Ho-so-mat\/Thalidomide—Tham-hoa-den-toi-nhat-lich-su-y-duoc-the-gioi-i305022\/<\/a><\/p>\n\n\n\n
$\"\"$
Ch\u1ec9 trong 3 n\u0103m, s\u1ed1 n\u1ea1n nh\u00e2n d\u1ecb t\u1eadt do d\u00f9ng thu\u1ed1c thalidomide gia t\u0103ng ch\u00f3ng m\u1eb7t, v\u00e0 thalidomide \u0111\u00e3 bi\u1ebfn th\u00e0nh th\u1ea3m h\u1ecda l\u1edbn nh\u1ea5t trong l\u1ecbch s\u1eed ng\u00e0nh y d\u01b0\u1ee3c th\u1ebf gi\u1edbi.<\/figcaption><\/figure>\n\n\n\n
3. Arm\/Arm assignment \u2013 Nh\u00e1nh nghi\u00ean c\u1ee9u\/Ch\u1ec9 \u0111\u1ecbnh nh\u00e1nh nghi\u00ean c\u1ee9u<\/strong><\/h3>\n\n\n\n
Vi\u1ec7c ch\u1ec9 \u0111\u1ecbnh m\u1ed9t nh\u00f3m ho\u1eb7c nh\u00f3m nh\u1ecf nh\u1eefng ng\u01b0\u1eddi tham gia th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng nh\u1eadn can thi\u1ec7p, ho\u1eb7c kh\u00f4ng can thi\u1ec7p, nh\u01b0 \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u^{3<\/sup><\/p>\n\n\n\n}
V\u00ed d\u1ee5: <\/strong><\/h3>\n\n\n\n
Ng\u01b0\u1eddi X tham gia nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c ph\u00e2n v\u00e0o nh\u00f3m can thi\u1ec7p (s\u1eed d\u1ee5ng thu\u1ed1c nghi\u00ean c\u1ee9u) => g\u1ecdi l\u00e0 nh\u00e1nh can thi\u1ec7p.<\/p>\n\n\n\n
4. Assessment – \u0110\u00e1nh gi\u00e1<\/strong><\/h3>\n\n\n\n
M\u1ed9t quy tr\u00ecnh (v\u00ed d\u1ee5: x\u00e9t nghi\u1ec7m m\u00e1u, qu\u00e9t, v.v.) \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 t\u1ea1o d\u1eef li\u1ec7u theo y\u00eau c\u1ea7u c\u1ee7a th\u1eed nghi\u1ec7m.<\/p>\n\n\n\n
5. Background therapy – Li\u1ec7u ph\u00e1p n\u1ec1n<\/strong><\/h3>\n\n\n\n
Li\u1ec7u ph\u00e1p n\u1ec1n l\u00e0 lo\u1ea1i thu\u1ed1c hi\u1ec7n t\u1ea1i \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng th\u01b0\u1eddng xuy\u00ean nh\u01b0 m\u1ed9t ti\u00eau chu\u1ea9n ch\u0103m s\u00f3c cho m\u1ed9t t\u00ecnh tr\u1ea1ng \/ b\u1ec7nh c\u1ee5 th\u1ec3.<\/p>\n\n\n\n
V\u00ed d<\/strong>\u1ee5: <\/h4>\n\n\n\n
Trong \u0111i\u1ec1u tr\u1ecb t\u0103ng huy\u1ebft \u00e1p, c\u00e1c nh\u00f3m thu\u1ed1c ARB, ACEI, CCB, l\u1ee3i ti\u1ec3u \u0111\u01b0\u1ee3c xem nh\u01b0 c\u00e1c li\u1ec7u ph\u00e1p n\u1ec1n \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb kh\u1edfi \u0111\u1ea7u cho b\u1ec7nh nh\u00e2n. <\/p>\n\n\n\n
6. Blinding<\/strong> \u2013 L\u00e0m m\u00f9<\/strong><\/h3>\n\n\n\n
M\u1ed9t lo\u1ea1i thi\u1ebft k\u1ebf th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng trong \u0111\u00f3 m\u1ed9t ho\u1eb7c nhi\u1ec1u b\u00ean li\u00ean quan \u0111\u1ebfn th\u1eed nghi\u1ec7m, ch\u1eb3ng h\u1ea1n nh\u01b0 nh\u00f3m nghi\u00ean c\u1ee9u ho\u1eb7c ng\u01b0\u1eddi tham gia, kh\u00f4ng bi\u1ebft ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb n\u00e0o \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh cho nh\u1eefng ng\u01b0\u1eddi tham gia n\u00e0o. Ph\u01b0\u01a1ng ph\u00e1p n\u00e0y nh\u1eb1m h\u1ea1n ch\u1ebf bias khi b\u1ec7nh nh\u00e2n v\u00e0 nh\u00e0 \u0111i\u1ec1u tr\u1ecb bi\u1ebft m\u00ecnh thu\u1ed9c nh\u00f3m n\u00e0o.<\/p>\n\n\n\n
C\u00e1c lo\u1ea1i blinding s\u1eed d\u1ee5ng trong nghi\u00ean c\u1ee9u bao g\u1ed3m^{4<\/sup><\/h4>\n\n\n\nNh\u00e3n m\u1edf (open-label):<\/strong> T\u1ea5t c\u1ea3 ng\u01b0\u1eddi tham gia \u0111\u1ec1u bi\u1ebft m\u00ecnh thu\u1ed9c nh\u00f3m n\u00e0o c\u1ee7a nghi\u00ean c\u1ee9u<\/p>\n\n\n\n
M\u00f9 \u0111\u01a1n (Single blind<\/strong>): Ch\u1ec9 b\u1ec7nh nh\u00e2n kh\u00f4ng bi\u1ebft m\u00ecnh thu\u1ed9c nh\u00f3m n\u00e0o<\/p>\n\n\n\n
M\u00f9 \u0111\u00f4i (Double blind):<\/strong> Trong m\u1ed9t th\u1eed nghi\u1ec7m m\u00f9 \u0111\u00f4i, ch\u1ec9 c\u00f3 nghi\u00ean c\u1ee9u vi\u00ean bi\u1ebft lo\u1ea1i thu\u1ed1c nghi\u00ean c\u1ee9u m\u00e0 ng\u01b0\u1eddi tham gia \u0111ang nh\u1eadn; nh\u1eefng ng\u01b0\u1eddi tham gia, b\u00e1c s\u0129, y t\u00e1 v\u00e0 nh\u00e2n vi\u00ean th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng kh\u00e1c kh\u00f4ng \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o..<\/p>\n\n\n\n
M\u00f9 ba (triple blind<\/strong>): c\u1ea3 b\u1ec7nh nh\u00e2n, ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n can thi\u1ec7p v\u00e0 ng\u01b0\u1eddi ph\u00e2n t\u00edch k\u1ebft qu\u1ea3 \u0111\u1ec1u kh\u00f4ng bi\u1ebft b\u1ec7nh nh\u00e2n thu\u1ed9c nh\u00f3m n\u00e0o<\/p>\n\n\n\n
PROBE (Prospective Randomized Open Blinded Endpoint<\/strong>): \u00c1p d\u1ee5ng cho nh\u1eefng nghi\u00ean c\u1ee9u nh\u00e3n m\u1edf (open-label), ch\u1ec9 ng\u01b0\u1eddi ph\u00e2n t\u00edch k\u1ebft qu\u1ea3 kh\u00f4ng bi\u1ebft b\u1ec7nh nh\u00e2n thu\u1ed9c nh\u00f3m n\u00e0o.<\/p>\n\n\n\n
<\/figure><\/li><\/ul><\/figure>\n\n\n\n7. Control \u2013 Nh\u00f3m ch\u1ee9ng<\/strong><\/h3>\n\n\n\nPh\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb d\u00f9ng \u0111\u1ec3 so s\u00e1nh, \u0111\u1ed1i ch\u1ee9ng v\u1edbi nh\u00f3m \u0111i\u1ec1u tr\u1ecb ho\u1eb7c ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb \u201cti\u00eau chu\u1ea9n\u201d \u0111\u01b0\u1ee3c so s\u00e1nh v\u1edbi ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb nghi\u00ean c\u1ee9u.<\/p>\n\n\n\n
Nh\u00f3m ch\u1ee9ng c\u00f3 th\u1ec3 l\u00e0 ng\u01b0\u1eddi kh\u1ecfe m\u1ea1nh, ng\u01b0\u1eddi kh\u00f4ng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb, ng\u01b0\u1eddi d\u00f9ng placebo, ng\u01b0\u1eddi d\u00f9ng ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb \u201cti\u00eau chu\u1ea9n\u201d trong th\u1ef1c h\u00e0nh hi\u1ec7n t\u1ea1i ho\u1eb7c c\u00e1c \u0111i\u1ec1u tr\u1ecb kh\u00e1c.<\/p>\n\n\n\n
8. Treatment group\/ Experimental group \u2013 Nh\u00f3m \u0111i\u1ec1u tr\u1ecb\/Nh\u00f3m can thi\u1ec7p<\/strong><\/h3>\n\n\n\nNh\u00f3m \u0111i\u1ec1u tr\u1ecb<\/strong> (c\u00f2n g\u1ecdi l\u00e0 nh\u00f3m th\u1eed nghi\u1ec7m<\/strong> ) nh\u1eadn \u0111\u01b0\u1ee3c ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb m\u00e0 nh\u00e0 nghi\u00ean c\u1ee9u quan t\u00e2m \u0111\u1ebfn t\u00e1c \u0111\u1ed9ng c\u1ee7a n\u00f3 \u0111\u1ebfn b\u1ec7nh nh\u00e2n^{6<\/sup><\/p>\n\n\n\n}
V\u00ed d\u1ee5<\/strong>: <\/strong><\/strong><\/h3>\n\n\n\nB\u1ea1n quan t\u00e2m \u0111\u1ebfn vi\u1ec7c li\u1ec7u sinh vi\u00ean \u0111\u1ea1i h\u1ecdc c\u00f3 ho\u1ea1t \u0111\u1ed9ng t\u1ed1t h\u01a1n \u1edf tr\u01b0\u1eddng hay kh\u00f4ng n\u1ebfu h\u1ecd \u0111\u01b0\u1ee3c tr\u1ea3 ti\u1ec1n cho th\u00e0nh t\u00edch c\u1ee7a m\u00ecnh. \u0110\u1ec3 ki\u1ec3m tra \u0111i\u1ec1u n\u00e0y, b\u1ea1n chia m\u1ed9t s\u1ed1 h\u1ecdc sinh th\u00e0nh c\u00e1c nh\u00f3m ch\u1ee9ng (control)<\/strong> v\u00e0 nh\u00f3m can thi\u1ec7p (experimental group)<\/strong><\/p>\n\n\n\n
B\u1ea1n tr\u1ea3 ti\u1ec1n cho c\u00e1c h\u1ecdc sinh trong nh\u00f3m \u0111i\u1ec1u tr\u1ecb \u0111\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c \u0111i\u1ec3m cao.(Nh\u00f3m can thi\u1ec7p)<\/li>
H\u1ecdc sinh trong nh\u00f3m \u0111\u1ed1i ch\u1ee9ng kh\u00f4ng nh\u1eadn \u0111\u01b0\u1ee3c b\u1ea5t k\u1ef3 kho\u1ea3n ti\u1ec1n n\u00e0o.(Nh\u00f3m ch\u1ee9ng)<\/li><\/ul>\n\n\n\nB\u1eb1ng c\u00e1ch so s\u00e1nh s\u1ef1 thay \u0111\u1ed5i trung b\u00ecnh v\u1ec1 \u0111i\u1ec3m c\u1ee7a h\u1ecd trong n\u0103m, b\u1ea1n c\u00f3 th\u1ec3 t\u00ecm hi\u1ec3u xem li\u1ec7u c\u00e1c khuy\u1ebfn kh\u00edch ti\u1ec1n t\u1ec7 c\u00f3 c\u1ea3i thi\u1ec7n th\u00e0nh t\u00edch c\u1ee7a tr\u01b0\u1eddng hay kh\u00f4ng.<\/p>\n\n\n\n
<\/figure><\/li><\/ul><\/figure>\n\n\n\n9. Clinical study\/<\/strong> International Study – Nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng ^{3<\/sup><\/strong><\/h3>\n\n\n\n<\/a>M\u1ed9t lo\u1ea1i nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trong \u0111\u00f3 nh\u1eefng ng\u01b0\u1eddi tham gia \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh v\u00e0o c\u00e1c nh\u00f3m nh\u1eadn m\u1ed9t ho\u1eb7c nhi\u1ec1u can thi\u1ec7p \/ \u0111i\u1ec1u tr\u1ecb (ho\u1eb7c kh\u00f4ng can thi\u1ec7p) \u0111\u1ec3 c\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u c\u00f3 th\u1ec3 \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng c\u1ee7a c\u00e1c can thi\u1ec7p \u0111\u1ed1i v\u1edbi c\u00e1c k\u1ebft qu\u1ea3 li\u00ean quan \u0111\u1ebfn y sinh ho\u1eb7c s\u1ee9c kh\u1ecfe. C\u00e1c b\u00e0i t\u1eadp \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh theo quy tr\u00ecnh c\u1ee7a nghi\u00ean c\u1ee9u. Nh\u1eefng ng\u01b0\u1eddi tham gia c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb ho\u1eb7c c\u00e1c lo\u1ea1i can thi\u1ec7p kh\u00e1c.<\/strong><\/p>\n\n\n\n
Ch\u00fa \u00fd l\u00e0 <\/strong>Clinical Study<\/strong> c\u00f2n c\u00f3 t\u00ean g\u1ecdi kh\u00e1c l\u00e0 <\/strong>International Study<\/strong><\/a><\/p>\n\n\n\n
10. ClinicalTrials.gov identifier (NCT number)<\/strong> – M\u00e3 nh\u1eadn d\u1ea1ng nghi\u00ean c\u1ee9u<\/h3>\n\n\n\nM\u00e3 nh\u1eadn d\u1ea1ng duy nh\u1ea5t \u0111\u01b0\u1ee3c c\u1ea5p cho m\u1ed7i nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng khi \u0111\u0103ng k\u00fd t\u1ea1i ClinicalTrials.gov. \u0110\u1ecbnh d\u1ea1ng l\u00e0 “NCT” theo sau l\u00e0 m\u1ed9t s\u1ed1 c\u00f3 8 ch\u1eef s\u1ed1 (v\u00ed d\u1ee5: NCT00000419).<\/p>\n\n\n\n
11. Observational study – Nghi\u00ean c\u1ee9u quan s\u00e1t<\/strong><\/h3>\n\n\n\nM\u1ed9t nghi\u00ean c\u1ee9u quan s\u00e1t \u0111i\u1ec1u tra k\u1ebft qu\u1ea3 s\u1ee9c kh\u1ecfe gi\u1eefa c\u00e1c nh\u00f3m ng\u01b0\u1eddi trong cu\u1ed9c s\u1ed1ng h\u00e0ng ng\u00e0y c\u1ee7a h\u1ecd t\u1ea1i nh\u00e0, c\u01a1 quan ho\u1eb7c v\u0103n ph\u00f2ng b\u00e1c s\u0129, n\u01a1i vi\u1ec7c ch\u1ec9 \u0111\u1ecbnh ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb ho\u1eb7c c\u00e1c th\u1ee7 t\u1ee5c kh\u00e1c l\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a vi\u1ec7c ch\u0103m s\u00f3c y t\u1ebf th\u00f4ng th\u01b0\u1eddng c\u1ee7a h\u1ecd (kh\u00f4ng do \u0111i\u1ec1u tra vi\u00ean ch\u1ec9 \u0111\u1ecbnh).<\/p>\n\n\n\n
12. Superiority \u2013 Nghi\u00ean c\u1ee9u v\u01b0\u1ee3t tr\u1ed9i<\/strong><\/h3>\n\n\n\n\u0110\u00e1nh gi\u00e1 m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb m\u1edbi c\u00f3 t\u1ed1t h\u01a1n ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb hi\u1ec7n h\u00e0nh, ho\u1eb7c so v\u1edbi nh\u00f3m ch\u1ee9ng (gi\u1ea3 d\u01b0\u1ee3c)<\/p>\n\n\n\n
13. Equivalence \u2013 Nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng<\/strong><\/h3>\n\n\n\n\u0110\u00e1nh gi\u00e1 m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb m\u1edbi t\u01b0\u01a1ng \u0111\u01b0\u01a1ng (kh\u00f4ng t\u1ed1t c\u0169ng kh\u00f4ng t\u1ec7 h\u01a1n) so v\u1edbi \u0111i\u1ec1u tr\u1ecb hi\u1ec7n t\u1ea1i \u0111\u01b0\u1ee3c so s\u00e1nh.<\/p>\n\n\n\n
14. Non \u2013 inferiority \u2013 Nghi\u00ean c\u1ee9u kh\u00f4ng thua k\u00e9m<\/strong><\/h3>\n\n\n\n\u0110\u00e1nh gi\u00e1 m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p m\u1edbi kh\u00f4ng thua k\u00e9m so v\u1edbi \u0111i\u1ec1u tr\u1ecb hi\u1ec7n c\u00f3. Ti\u1ebfn h\u00e0nh khi nghi\u00ean c\u1ee9u v\u01b0\u1ee3t tr\u1ed9i (superiority) \u0111\u01b0\u1ee3c cho l\u00e0 vi ph\u1ea1m \u0111\u1ea1o \u0111\u1ee9c ho\u1eb7c \u0111\u01b0\u1ee3c c\u00e2n nh\u1eafc khi nh\u00e0 nghi\u00ean c\u1ee9u ng\u00e0y t\u1eeb \u0111\u1ea7u \u0111\u00e3 d\u1ef1 \u0111o\u00e1n k\u1ebft qu\u1ea3 v\u01b0\u1ee3t tr\u1ed9i c\u00f3 th\u1ec3 kh\u00f4ng \u0111o\u1ea1t \u0111\u01b0\u1ee3c.<\/p>\n\n\n\n
N\u1ebfu v\u1eabn ch\u01b0a ph\u00e2n bi\u1ec7t \u0111\u01b0\u1ee3c 3 lo\u1ea1i nghi\u00ean c\u1ee9u 12,13, 14 th\u00ec c\u00e1c b\u1ea1n c\u00f3 th\u1ec3 d\u1eebng l\u1ea1i m\u1ed9t ch\u00fat \u0111\u1ec3 \u0111\u1ecdc so s\u00e1nh \u1edf b\u1ea3ng c\u00f9ng v\u00ed d\u1ee5 ph\u00eda d\u01b0\u1edbi \u0111\u00e2y nh\u00e9: <\/strong><\/p>\n\n\n\n
<\/strong><\/td> Interpretation<\/strong><\/td><\/tr>
Superiority \u2013 Nghi\u00ean c\u1ee9u v\u01b0\u1ee3t tr\u1ed9i<\/strong><\/td> Nh\u00f3m can thi\u1ec7p > Nh\u00f3m ch\u1ee9ng<\/strong><\/td><\/tr>
Equivalence \u2013 Nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng<\/strong><\/td> Nh\u00f3m Can thi\u1ec7p t\u01b0\u01a1ng \u0111\u01b0\u01a1ng nh\u1edbm ch\u1ee9ng<\/strong><\/td><\/tr>
Non \u2013 inferiority<\/strong><\/td> Nh\u00f3m Can Thi\u1ec7p kh\u00f4ng kh\u00f4ng t\u1ec7 h\u01a1n \u1edf m\u1ee9c kh\u00f4ng ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\nV\u00ed d\u1ee5,<\/strong><\/h4>\n\n\n\nM\u1ed9t th\u1eed nghi\u1ec7m c\u00f3 th\u1ec3 so s\u00e1nh hi\u1ec7u qu\u1ea3 c\u1ee7a m\u1ed9t lo\u1ea1i kh\u00e1ng sinh m\u1edbi v\u1edbi m\u1ed9t lo\u1ea1i kh\u00e1ng sinh c\u0169 h\u01a1n. Tuy nhi\u00ean, so s\u00e1nh c\u1ee5 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng s\u1ebd ph\u1ee5 thu\u1ed9c v\u00e0o gi\u1ea3 thuy\u1ebft \u0111\u01b0\u1ee3c gi\u1ea3i quy\u1ebft. H\u00e3y s\u1eed d\u1ee5ng v\u00ed d\u1ee5 v\u1ec1 hai lo\u1ea1i kh\u00e1ng sinh cho cu\u1ed9c th\u1ea3o lu\u1eadn n\u00e0y.<\/p>\n\n\n\n
Ch\u00fang ta c\u00f3 th\u1ec3 x\u00e2y d\u1ef1ng 3 gi\u1ea3 thuy\u1ebft c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c gi\u1ea3i quy\u1ebft khi so s\u00e1nh hai lo\u1ea1i kh\u00e1ng sinh n\u00e0y. Ba gi\u1ea3 thuy\u1ebft l\u00e0:<\/p>\n\n\n\n
Thu\u1ed1c kh\u00e1ng sinh m\u1edbi \u00edt nh\u1ea5t c\u0169ng t\u1ed1t nh\u01b0<\/strong> thu\u1ed1c kh\u00e1ng sinh c\u0169.<\/li>
Thu\u1ed1c Kh\u00e1ng Sinh M\u1edbi t\u1ed1t h\u01a1n<\/strong> Thu\u1ed1c Kh\u00e1ng Sinh C\u0169.<\/li>
Thu\u1ed1c kh\u00e1ng sinh m\u1edbi t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi<\/strong> thu\u1ed1c kh\u00e1ng sinh c\u0169.<\/li><\/ol>\n\n\n\nM\u1eb7c d\u00f9 m\u1ed7i gi\u1ea3 thuy\u1ebft n\u00e0y c\u00f3 v\u1ebb gi\u1ed1ng nhau, nh\u01b0ng ch\u00fang l\u00e0 nh\u1eefng c\u00e2u h\u1ecfi khoa h\u1ecdc h\u01a1i kh\u00e1c nhau, do \u0111\u00f3 m\u1ed7i gi\u1ea3 thuy\u1ebft \u0111\u00f2i h\u1ecfi m\u1ed9t th\u1eed nghi\u1ec7m th\u1ed1ng k\u00ea h\u01a1i kh\u00e1c nhau. \u0110\u1ed1i v\u1edbi gi\u1ea3 thuy\u1ebft \u0111\u1ea7u ti\u00ean (\u201c\u00edt nh\u1ea5t l\u00e0 t\u1ed1t nh\u01b0\u201d), Thu\u1ed1c kh\u00e1ng sinh m\u1edbi ph\u1ea3i t\u1ed1t nh\u01b0 Thu\u1ed1c kh\u00e1ng sinh c\u0169, nh\u01b0ng n\u00f3 c\u0169ng c\u00f3 th\u1ec3 t\u1ed1t h\u01a1n Thu\u1ed1c kh\u00e1ng sinh c\u0169.<\/strong><\/p>\n\n\n\n
15. Cross-over trial<\/strong> \u2013 Thi\u1ebft k\u1ebf giao ch\u00e9o<\/strong><\/h3>\n\n\n\nM\u1ed9t th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng trong \u0111\u00f3 c\u00e1c nh\u00f3m t\u00ecnh nguy\u1ec7n vi\u00ean \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n hai ho\u1eb7c nhi\u1ec1u bi\u1ec7n ph\u00e1p can thi\u1ec7p theo m\u1ed9t th\u1ee9 t\u1ef1 c\u1ee5 th\u1ec3. N\u00f3 th\u1ec3 hi\u1ec7n m\u1ed9t s\u1ed1 l\u1ee3i th\u1ebf, ch\u1eb3ng h\u1ea1n nh\u01b0 ph\u01b0\u01a1ng sai th\u1ea5p do \u0111i\u1ec1u tr\u1ecb v\u00e0 ki\u1ec3m so\u00e1t l\u00e0 c\u00f9ng m\u1ed9t ng\u01b0\u1eddi tham gia, v\u00e0 kh\u1ea3 n\u0103ng bao g\u1ed3m m\u1ed9t s\u1ed1 ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb. Tuy nhi\u00ean, gi\u1eefa c\u00e1c giai \u0111o\u1ea1n \u0111i\u1ec1u tr\u1ecb kh\u00e1c nhau ph\u1ea3i c\u00f3 \u0111\u1ee7 kho\u1ea3ng c\u00e1ch th\u1eddi gian (giai \u0111o\u1ea1n r\u1eeda tr\u00f4i\/<\/strong> washout period<\/strong>).<\/strong><\/p>\n\n\n\n
V\u00ed d\u1ee5:<\/strong><\/h4>\n\n\n\nThi\u1ebft k\u1ebf th\u1eed nghi\u1ec7m ch\u00e9o \u201c2×2\u201d l\u00e0 trong \u0111\u00f3 m\u1ed9t nh\u00f3m nh\u1eadn thu\u1ed1c A v\u00e0o \u0111\u1ea7u th\u1eed nghi\u1ec7m v\u00e0 sau \u0111\u00f3 nh\u1eadn thu\u1ed1c B cho ph\u1ea7n c\u00f2n l\u1ea1i c\u1ee7a th\u1eed nghi\u1ec7m. Trong nh\u00f3m th\u1ee9 hai, nh\u1eefng ng\u01b0\u1eddi tham gia nh\u1eadn \u0111\u01b0\u1ee3c thu\u1ed1c B \u0111\u1ea7u ti\u00ean v\u00e0 sau \u0111\u00f3 l\u00e0 thu\u1ed1c A. Do \u0111\u00f3, thu\u1eadt ng\u1eef \u201cch\u00e9o\u201d \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 m\u00f4 t\u1ea3 th\u1ee9 t\u1ef1 m\u00e0 h\u1ecd \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh; v\u00ed d\u1ee5 ban \u0111\u1ea7u l\u00e0 thu\u1ed1c A v\u00e0 sau \u0111\u00f3 l\u00e0 thu\u1ed1c B, ho\u1eb7c ban \u0111\u1ea7u l\u00e0 thu\u1ed1c B v\u00e0 sau \u0111\u00f3 l\u00e0 ma t\u00fay A. T\u1ea5t c\u1ea3 nh\u1eefng ng\u01b0\u1eddi tham gia nh\u1eadn \u0111\u01b0\u1ee3c c\u1ea3 hai lo\u1ea1i thu\u1ed1c trong qu\u00e1 tr\u00ecnh nghi\u00ean c\u1ee9u.<\/p>\n\n\n\n
<\/figure>\n\n\n\nNgu\u1ed3n \u1ea3nh<\/em>: https:\/\/toolbox.eupati.eu\/resources\/clinical-trial-designs\/?print=print<\/a><\/p>\n\n\n\n
16. Parallel arm \u2013 Thi\u1ebft k\u1ebf song song<\/strong><\/h3>\n\n\n\nHai nh\u00e1nh ti\u1ebfn nghi\u00ean c\u1ee9u h\u00e0nh song song, \u0111\u1ed3ng th\u1eddi v\u1edbi nhau.<\/p>\n\n\n\nTrong nghi\u00ean c\u1ee9u c\u00f3 thi\u1ebft k\u1ebf d\u1ea1ng parallel (song song), sau khi ph\u00e2n nh\u00f3m ng\u1eabu nhi\u00ean, m\u1ed7i ng\u01b0\u1eddi tham gia s\u1ebd \u1edf trong nh\u00f3m \u0111i\u1ec1u tr\u1ecb<\/a> \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh c\u1ee7a h\u1ecd trong su\u1ed1t th\u1eddi gian nghi\u00ean c\u1ee9u. Thi\u1ebft k\u1ebf nh\u00f3m song song c\u00f3 th\u1ec3 \u00e1p d\u1ee5ng cho nhi\u1ec1u b\u1ec7nh, cho ph\u00e9p ch\u1ea1y th\u00ed nghi\u1ec7m \u0111\u1ed3ng th\u1eddi \u1edf m\u1ed9t s\u1ed1 nh\u00f3m v\u00e0 c\u00e1c nh\u00f3m c\u00f3 th\u1ec3 \u1edf c\u00e1c \u0111\u1ecba \u0111i\u1ec3m ri\u00eang bi\u1ec7t^{5<\/sup><\/p>\n\n\n\n}
<\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/toolbox.eupati.eu\/resources\/clinical-trial-designs\/<\/a><\/p>\n\n\n\n
17. Factorial Design \u2013 Thi\u1ebft k\u1ebf giai th\u1eeba<\/strong><\/h3>\n\n\n\nM\u1ee5c ti\u00eau c\u1ee7a thi\u1ebft k\u1ebf giai th\u1eeba l\u00e0 gi\u00fap \u0111\u00e1nh gi\u00e1 s\u1ef1 t\u01b0\u01a1ng t\u00e1c, hay t\u00e1c \u0111\u1ed9ng c\u1ed9ng g\u1ed9p c\u1ee7a >= 2 can thi\u1ec7p, khi ri\u00eang l\u1ebb ho\u1eb7c ph\u1ed1i h\u1ee3p. Ch\u1eb3ng h\u1ea1n khi so s\u00e1nh v\u1edbi hi\u1ec7u qu\u1ea3 c\u1ee7a c\u00e1c lo\u1ea1i thu\u1ed1c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng, \u00edt h\u01a1n ho\u1eb7c nhi\u1ec1u h\u01a1n so v\u1edbi c\u00e1c lo\u1ea1i thu\u1ed1c ri\u00eang l\u1ebb. M\u00f4 h\u00ecnh 2×2 l\u00e0 ph\u1ed5 bi\u1ebfn nh\u1ea5t ^{4<\/sup><\/strong><\/p>\n\n\n\n}<\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/toolbox.eupati.eu\/resources\/clinical-trial-designs\/<\/a><\/p>\n\n\n\n
18. Dosing discontinuation \u2013 Gi\u00e1n \u0111o\u1ea1n li\u1ec1u d\u00f9ng<\/strong><\/h3>\n\n\n\n\u0110i\u1ec3m \/ th\u1eddi gian khi m\u1ed9t b\u1ec7nh nh\u00e2n t\u00ecnh nguy\u1ec7n ng\u1eebng v\u0129nh vi\u1ec5n thu\u1ed1c nghi\u00ean c\u1ee9u v\u00ec b\u1ea5t k\u1ef3 l\u00fd do g\u00ec. \u0110i\u1ec1u n\u00e0y c\u00f3 th\u1ec3 v\u00e0o cu\u1ed1i nghi\u00ean c\u1ee9u ho\u1eb7c tr\u01b0\u1edbc khi k\u1ebft th\u00fac n\u1ebfu b\u1ec7nh nh\u00e2n mu\u1ed1n ng\u1eebng d\u00f9ng thu\u1ed1c v\u00ec m\u1ed9t l\u00fd do n\u00e0o \u0111\u00f3.<\/p>\n\n\n\n19. Early patient withdrawal (premature withdrawal) – B\u1ec7nh nh\u00e2n r\u00fat kh\u1ecfi nghi\u00ean c\u1ee9u s\u1edbm<\/strong><\/h3>\n\n\n\nTh\u1eddi \u0111i\u1ec3m \/ th\u1eddi \u0111i\u1ec3m b\u1ec7nh nh\u00e2n r\u1eddi kh\u1ecfi cu\u1ed9c th\u1eed nghi\u1ec7m tr\u01b0\u1edbc khi ho\u00e0n th\u00e0nh k\u1ebf ho\u1ea1ch c\u1ee7a d\u00f9ng thu\u1ed1c \u0111i\u1ec1u tra \/ th\u1eed nghi\u1ec7m v\u00e0 t\u1ea5t c\u1ea3 c\u00e1c \u0111\u00e1nh gi\u00e1 (bao g\u1ed3m c\u1ea3 theo d\u00f5i).<\/p>\n\n\n\n20. Eligibility Criteria \u2013 Ti\u00eau chu\u1ea9n \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n<\/strong><\/h3>\n\n\n\nNh\u1eefng y\u00eau c\u1ea7u m\u00e0 nh\u1eefng ng\u01b0\u1eddi mu\u1ed1n tham gia v\u00e0o m\u1ed9t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng ph\u1ea3i \u0111\u00e1p \u1ee9ng. Ti\u00eau ch\u00ed \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ( Eligibility Criteria) <\/strong>bao g\u1ed3m c\u1ea3 ti\u00eau ch\u00ed thu nh\u1eadn<\/strong> (Inclusion criteria)<\/strong> v\u00e0 ti\u00eau ch\u00ed lo\u1ea1i tr\u1eeb (Exclusion criteria)<\/strong> v\u00e0 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh trong giao th\u1ee9c. Ch\u00fang c\u00f3 th\u1ec3 bao g\u1ed3m tu\u1ed5i, gi\u1edbi t\u00ednh, ti\u1ec1n s\u1eed b\u1ec7nh v\u00e0 t\u00ecnh tr\u1ea1ng s\u1ee9c kh\u1ecfe hi\u1ec7n t\u1ea1i.<\/p>\n\n\n\n<\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/www.researchgate.net\/figure\/Eligibility-criteria-employed_tbl1_315972984<\/a><\/p>\n\n\n\n
21. European Medicines Agency<\/strong>– EMA<\/strong><\/h3>\n\n\n\nC\u01a1 quan Y t\u1ebf Ch\u00e2u \u00c2u. M\u1ed9t c\u01a1 quan c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u gi\u00e1m s\u00e1t vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c. <\/p>\n\n\n\n22. Enrollment – Ghi danh<\/strong><\/h3>\n\n\n\nTh\u1eddi \u0111i\u1ec3m, ho\u1eb7c th\u1eddi \u0111i\u1ec3m, t\u00ecnh nguy\u1ec7n vi\u00ean tham gia phi\u00ean t\u00f2a, sau khi \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1ef1 \u0111\u1ed3ng \u00fd. Thu\u1eadt ng\u1eef t\u01b0\u01a1ng t\u1ef1 c\u0169ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh s\u1ed1 l\u01b0\u1ee3ng ng\u01b0\u1eddi tham gia th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng. <\/p>\n\n\n\n23. Epoch <\/strong><\/h3>\n\n\n\nGiai \u0111o\u1ea1n d\u1ef1 ki\u1ebfn \u200b\u200bc\u1ee7a c\u00e1c t\u00ecnh nguy\u1ec7n vi\u00ean tham gia th\u1eed nghi\u1ec7m. C\u00e1c epoch \u0111i\u1ec3n h\u00ecnh l\u00e0: x\u00e1c \u0111\u1ecbnh t\u00ednh \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n c\u1ee7a \u0111\u1ed1i t\u01b0\u1ee3ng, lo\u1ea1i b\u1ecf c\u00e1c \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3 (t\u1ee9c l\u00e0 m\u1ed9t kho\u1ea3ng th\u1eddi gian khi c\u00e1c \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3 ng\u1eebng l\u1ea1i), ti\u1ebfp x\u00fac v\u1edbi \u0111\u1ed1i t\u01b0\u1ee3ng \u0111i\u1ec1u tr\u1ecb ho\u1eb7c theo d\u00f5i \u0111\u1ed1i t\u01b0\u1ee3ng sau khi \u0111i\u1ec1u tr\u1ecb k\u1ebft th\u00fac.<\/p>\n\n\n\n<\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/slideplayer.com\/slide\/3301826\/<\/a><\/p>\n\n\n\n
24. FDA<\/strong> – C\u1ee5c Qu\u1ea3n l\u00fd Thu\u1ed1c V\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3<\/h3>\n\n\n\nM\u1ed9t c\u01a1 quan ch\u00ednh ph\u1ee7 trong B\u1ed9 Y t\u1ebf v\u00e0 D\u1ecbch v\u1ee5 Nh\u00e2n sinh Hoa K\u1ef3 gi\u00e1m s\u00e1t s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng c\u1ee7a Qu\u1ed1c gia b\u1eb1ng c\u00e1ch \u0111\u1ea3m b\u1ea3o r\u1eb1ng thu\u1ed1c cho ng\u01b0\u1eddi v\u00e0 th\u00fa y, v\u1eafc xin, s\u1ea3n ph\u1ea9m sinh h\u1ecdc, thi\u1ebft b\u1ecb y t\u1ebf, m\u1ef9 ph\u1ea9m, th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng, ngu\u1ed3n cung c\u1ea5p th\u1ef1c ph\u1ea9m v\u00e0 b\u1ea5t k\u1ef3 s\u1ea3n ph\u1ea9m n\u00e0o mang l\u1ea1i hi\u1ec7u qu\u1ea3 b\u1ee9c x\u1ea1 an to\u00e0n, hi\u1ec7u qu\u1ea3 v\u00e0 b\u1ea3o m\u1eadt.<\/p>\n\n\n\n<\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/www.fda.gov\/about-fda<\/a><\/p>\n\n\n\n
25. Health Authority- C\u01a1 quan y t\u1ebf<\/strong><\/h3>\n\n\n\nM\u1ed9t c\u01a1 quan y t\u1ebf qu\u1ed1c gia ho\u1eb7c qu\u1ed1c t\u1ebf c\u00f3 th\u1ea9m quy\u1ec1n qu\u1ea3n l\u00fd v\u00e0 \u0111i\u1ec1u ch\u1ec9nh m\u1ed9t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng.<\/p>\n\n\n\n26. Indication – Ch\u1ec9 \u0111\u1ecbnh<\/strong><\/h3>\n\n\n\nM\u1ed9t c\u0103n b\u1ec7nh, tri\u1ec7u ch\u1ee9ng ho\u1eb7c m\u1ed9t t\u1eadp h\u1ee3p c\u00e1c t\u00ecnh hu\u1ed1ng c\u1ee5 th\u1ec3 l\u00e0m cho m\u1ed9t x\u00e9t nghi\u1ec7m, thu\u1ed1c, th\u1ee7 thu\u1eadt ho\u1eb7c ph\u1eabu thu\u1eadt c\u1ee5 th\u1ec3 \u0111\u01b0\u1ee3c khuy\u1ebfn kh\u00edch. \u0110\u1ed1i v\u1edbi m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb, m\u1ed9t ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec1 c\u1eadp \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb \u0111\u00f3 \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb m\u1ed9t b\u1ec7nh c\u1ee5 th\u1ec3.<\/p>\n\n\n\n27. Informed consent \u2013 M\u1eabu th\u00f4ng b\u00e1o ch\u1ea5p thu\u1eadn<\/strong><\/h3>\n\n\n\nC\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u s\u1eed d\u1ee5ng s\u1ef1 \u0111\u1ed3ng \u00fd \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o \u0111\u1ec3 gi\u1ea3i th\u00edch th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng cho c\u00e1c t\u00ecnh nguy\u1ec7n vi\u00ean ti\u1ec1m n\u0103ng.<\/p>\n\n\n\n
M\u1ee5c \u0111\u00edch c\u1ee7a n\u00f3 l\u00e0 \u0111\u1ec3 b\u1ea3o v\u1ec7 ng\u01b0\u1eddi tham gia. N\u00f3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng khi ai \u0111\u00f3 quan t\u00e2m \u0111\u1ebfn vi\u1ec7c tham gia h\u1ecfi v\u1ec1 nghi\u00ean c\u1ee9u v\u00e0 trong su\u1ed1t qu\u00e1 tr\u00ecnh nghi\u00ean c\u1ee9u, cho \u0111\u1ebfn khi nghi\u00ean c\u1ee9u k\u1ebft th\u00fac. Th\u00f4ng tin n\u00e0y c\u0169ng \u0111\u01b0\u1ee3c vi\u1ebft trong m\u1ed9t t\u00e0i li\u1ec7u, \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 m\u1eabu ch\u1ea5p thu\u1eadn \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o, \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf r\u00f5 r\u00e0ng v\u00e0 d\u1ec5 hi\u1ec3u. <\/p>\n\n\n\n
N\u1ebfu m\u1ed9t ng\u01b0\u1eddi quy\u1ebft \u0111\u1ecbnh \u0111\u0103ng k\u00fd tham gia th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, h\u1ecd s\u1ebd k\u00fd v\u00e0o m\u1eabu \u0111\u1ed3ng \u00fd \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o \u0111\u1ec3 x\u00e1c nh\u1eadn r\u1eb1ng h\u1ecd hi\u1ec3u c\u00e1c chi ti\u1ebft c\u1ee7a th\u1eed nghi\u1ec7m v\u00e0 \u0111\u1ed3ng \u00fd tham gia. M\u1eabu ch\u1ea5p thu\u1eadn \u0111\u00e3 th\u00f4ng b\u00e1o kh\u00f4ng ph\u1ea3i l\u00e0 h\u1ee3p \u0111\u1ed3ng v\u00e0 ng\u01b0\u1eddi tham gia c\u00f3 th\u1ec3 r\u00fat kh\u1ecfi b\u1ea3n d\u00f9ng th\u1eed b\u1ea5t k\u1ef3 l\u00fac n\u00e0o v\u00e0 v\u00ec b\u1ea5t k\u1ef3 l\u00fd do g\u00ec. <\/p>\n\n\n\n<\/figure><\/li><\/ul> C\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u s\u1eed d\u1ee5ng s\u1ef1 \u0111\u1ed3ng \u00fd \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o \u0111\u1ec3 gi\u1ea3i th\u00edch th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng cho c\u00e1c t\u00ecnh nguy\u1ec7n vi\u00ean ti\u1ec1m n\u0103ng. <\/figcaption><\/figure>\n\n\n\n28. Institutional Review Board – Ban r\u00e0 so\u00e1t th\u1ec3 ch\u1ebf (IRB)<\/strong><\/h3>\n\n\n\nIRB (c\u00f2n \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 \u1ee7y ban \u0111\u1ea1o \u0111\u1ee9c \u0111\u1ed9c l\u1eadp (IEC), h\u1ed9i \u0111\u1ed3ng \u0111\u00e1nh gi\u00e1 \u0111\u1ea1o \u0111\u1ee9c (ERB) ho\u1eb7c h\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c nghi\u00ean c\u1ee9u (REB)) l\u00e0 m\u1ed9t nh\u00f3m c\u00e1c b\u00e1c s\u0129, nh\u00e0 khoa h\u1ecdc, ng\u01b0\u1eddi \u1ee7ng h\u1ed9, nh\u00e0 nghi\u00ean c\u1ee9u v\u00e0 c\u00e1c th\u00e0nh vi\u00ean c\u1ee7a c\u1ed9ng \u0111\u1ed3ng \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u00ednh th\u1ee9c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 xem x\u00e9t v\u00e0 gi\u00e1m s\u00e1t t\u1ea5t c\u1ea3 c\u00e1c nghi\u00ean c\u1ee9u li\u00ean quan \u0111\u1ebfn con ng\u01b0\u1eddi. <\/p>\n\n\n\n
IRB \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp \u0111\u1ec3 cung c\u1ea5p gi\u00e1m s\u00e1t \u0111\u1ea1o \u0111\u1ee9c v\u00e0 gi\u1ea3m thi\u1ec3u r\u1ee7i ro cho ng\u01b0\u1eddi tham gia.<\/p>\n\n\n\n
29. Investigational drug – Thu\u1ed1c nghi\u00ean c\u1ee9u<\/strong><\/h3>\n\n\n\nThu\u1ed1c \u0111ang \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong th\u1eed nghi\u1ec7m; \u0111\u1ecbnh ngh\u0129a n\u00e0y \u0111\u1ed3ng ngh\u0129a v\u1edbi \u201cthu\u1ed1c m\u1edbi nghi\u00ean c\u1ee9u\u201d ho\u1eb7c \u201cs\u1ea3n ph\u1ea9m thu\u1ed1c nghi\u00ean c\u1ee9u\u201d.<\/p>\n\n\n\n
30. Medication number – S\u1ed1 thu\u1ed1c <\/strong><\/h3>\n\n\n\nM\u1ed9t s\u1ed1 duy nh\u1ea5t tr\u00ean nh\u00e3n c\u1ee7a m\u1ed7i g\u00f3i thu\u1ed1c \u0111i\u1ec1u tra \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong th\u1eed nghi\u1ec7m \u0111\u1ec3 ph\u00e2n ph\u1ed1i v\u00e0 theo d\u00f5i thu\u1ed1c. Con s\u1ed1 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o thu\u1ed1c \u0111\u01b0\u1ee3c cung c\u1ea5p \u0111\u00fang s\u1ed1 l\u01b0\u1ee3ng cho c\u00e1c trung t\u00e2m nghi\u00ean c\u1ee9u kh\u00e1c nhau.<\/p>\n\n\n\n
31. Outcome measure \u2013 Ph\u00e9p \u0111o k\u1ebft c\u1ee5c<\/strong><\/h3>\n\n\n\nTrong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, m\u1ed9t ph\u00e9p \u0111o t\u1eadp h\u1ee3p \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong \u0111\u1ec1 c\u01b0\u01a1ng v\u00e0 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng c\u1ee7a m\u1ed9t can thi\u1ec7p \u0111\u1ed1i<\/p>\n\n\n\n
References & Further Reading<\/strong><\/h2>\n\n\n\nhttps:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm?fr=312.32<\/a><\/li>
https:\/\/www.fda.gov\/safety\/reporting-serious-problems-fda\/what-serious-adverse-event<\/a><\/li>
https:\/\/clinicaltrials.gov\/ct2\/about-studies\/glossary<\/a><\/li>
Ph\u1ea1m Ph\u01b0\u01a1ng H\u1ea1nh, Phan Quang Kh\u1ea3i, Ph\u1ea1m Tr\u1ea7n Thu Trang (2020). S\u00e1ch Th\u1ef1c h\u00e0nh Y h\u1ecdc Th\u1ef1c ch\u00fang, <\/em>Nh\u00e0 xu\u1ea5t b\u1ea3n Thanh Ni\u00ean, H\u00e0 N\u1ed9i.<\/li>
https:\/\/toolbox.eupati.eu\/resources\/clinical-trial-designs\/<\/a><\/li>
https:\/\/www.scribbr.com\/methodology\/control-group\/<\/a><\/li>
https:\/\/slideplayer.com\/slide\/3301826\/ <\/li>
C\u00e1c h\u00ecnh \u1ea3nh kh\u00f4ng thu\u1ed9c b\u1ea3n quy\u1ec1n c\u1ee7a Th\u01b0\u01a1ng Library \u0111\u01b0\u1ee3c tr\u00edch d\u1eabn ngu\u1ed3n ngay ph\u00eda d\u01b0\u1edbi \u1ea3nh. C\u00e1c h\u00ecnh \u1ea3nh \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch gi\u00e1o d\u1ee5c. <\/li><\/ol>\n\n\n\nB\u00e0i vi\u1ebft thu\u1ed9c chu\u1ed7i b\u00e0i<\/strong> C\u00e1ch \u0111\u1ecdc b\u00e0i b\u00e1o khoa h\u1ecdc theo phong c\u00e1ch sinh vi\u00ean<\/strong><\/h3>\n\n\n\n\u0110\u1ecdc l\u1ea1i ph\u1ea7n 1:<\/h3>\n\n\n\n\nC\u00e1ch \u0111\u1ecdc m\u1ed9t nghi\u00ean c\u1ee9u khoa h\u1ecdc theo phong c\u00e1ch sinh vi\u00ean (ph\u1ea7n 1)<\/a><\/blockquote><\/iframe>\n<\/div><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">\u0110\u1ecdc l\u1ea1i ph\u1ea7n 2:<\/h3>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-th\u01b0\u01a1ng-library wp-block-embed-th\u01b0\u01a1ng-library\"><div class=\"wp-block-embedwrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"L3ZD5zM2tu\"><a href=\"https:\/\/thuonglibrary.com\/nghien-cuu-khoa-hoc\/cach-doc-mot-nghien-cuu-khoa-hoc-theo-phong-cach-sinh-vien-phan-2\/\">C\u00e1ch \u0111\u1ecdc m\u1ed9t nghi\u00ean c\u1ee9u khoa h\u1ecdc theo phong c\u00e1ch sinh vi\u00ean (ph\u1ea7n 2)<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"“C\u00e1ch \u0111\u1ecdc m\u1ed9t nghi\u00ean c\u1ee9u khoa h\u1ecdc theo phong c\u00e1ch sinh vi\u00ean (ph\u1ea7n 2)” — Th\u01b0\u01a1ng Library\" src=\"https:\/\/thuonglibrary.com\/nghien-cuu-khoa-hoc\/cach-doc-mot-nghien-cuu-khoa-hoc-theo-phong-cach-sinh-vien-phan-2\/embed\/#?secret=L3ZD5zM2tu\" data-secret=\"L3ZD5zM2tu\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">\u0110\u1ecdc l\u1ea1i ph\u1ea7n 3:<\/h3>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-th\u01b0\u01a1ng-library wp-block-embed-th\u01b0\u01a1ng-library\"><div class=\"wp-block-embedwrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"e5SA43vZ4B\"><a href=\"https:\/\/thuonglibrary.com\/nghien-cuu-khoa-hoc\/cach-doc-mot-nghien-cuu-khoa-hoc-theo-phong-cach-sinh-vien-phan-3\/\">Hazard Ratio (HR) hay T\u1ec9 s\u1ed1 r\u1ee7i ro l\u00e0 g\u00ec<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"“Hazard Ratio (HR) hay T\u1ec9 s\u1ed1 r\u1ee7i ro l\u00e0 g\u00ec” — Th\u01b0\u01a1ng Library\" src=\"https:\/\/thuonglibrary.com\/nghien-cuu-khoa-hoc\/cach-doc-mot-nghien-cuu-khoa-hoc-theo-phong-cach-sinh-vien-phan-3\/embed\/#?secret=e5SA43vZ4B\" data-secret=\"e5SA43vZ4B\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p><strong><em>DISCLOSURE:<\/em><\/strong><\/p><p><em>C\u00e1c th\u00f4ng tin c\u1ee7a b\u00e0i vi\u1ebft ho\u00e0n to\u00e0n d\u1ef1a tr\u00ean hi\u1ec3u bi\u1ebft c\u00e1 nh\u00e2n, tr\u1ea3i nghi\u1ec7m v\u00e0 tham kh\u1ea3o c\u00e1c t\u00e0i li\u1ec7u chuy\u00ean ng\u00e0nh c\u1ee7a Th\u01b0\u01a1ng Library. B\u00e0i vi\u1ebft kh\u00f4ng \u0111\u1ea1i di\u1ec7n cho b\u1ea5t k\u00ec c\u00e1 nh\u00e2n hay t\u1ed5 ch\u1ee9c n\u00e0o kh\u00e1c. Vui l\u00f2ng kh\u00f4ng sao ch\u00e9p th\u00f4ng tin khi ch\u01b0a c\u00f3 s\u1ef1 \u0111\u1ed3ng \u00fd c\u1ee7a Th\u01b0\u01a1ng Library.<\/em><\/p><p><em>N\u1ebfu c\u00f3 g\u00f3p \u00fd v\u1ec1 b\u00e0i vi\u1ebft b\u1ea1n vui l\u00f2ng \u0111\u1ec3 l\u1ea1i l\u1eddi nh\u1eafn t\u1ea1i th\u01b0 m\u1ee5c L\u1eddi nh\u1eafn g\u1edfi. Th\u01b0\u01a1ng Library r\u1ea5t h\u00e2n h\u1ea1nh nh\u1eadn c\u00e1c th\u1eafc m\u1eafc, g\u00f3p \u00fd \u0111\u1ec3 n\u1ed9i dung ch\u1ea5t l\u01b0\u1ee3ng h\u01a1n.<\/em><\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Glossary of Clinical Trial Terms Trong nh\u1eefng l\u1ea7n \u0111\u1ea7u khi ti\u1ebfp x\u00fac v\u1edbi nh\u1eefng b\u00e0i b\u00e1o nghi\u00ean c\u1ee9u, m\u00ecnh ph\u1ea3i m\u1ea5t h\u00e0ng gi\u1edd \u0111\u1ed3ng h\u1ed3 \u0111\u1ec3 v\u1eeba \u0111\u1ecdc, v\u1eeba tra t\u1eeb \u0111i\u1ec3n c\u00e1c thu\u1eadt ng\u1eef n\u00e0y, v\u1eeba t\u00ecm c\u00e1c th\u00f4ng tin \u0111\u1ec3 hi\u1ec3u \u00fd ngh\u0129a c\u1ee7a ch\u00fang. Do \u0111\u00f3, hi … <\/p>\n","protected":false},"author":1,"featured_media":762,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","om_disable_all_campaigns":false,"WB4WB4WP_MODE":"","WB4WP_PAGE_SCRIPTS":"","WB4WP_PAGE_STYLES":"","WB4WP_PAGE_FONTS":"","WB4WP_PAGE_HEADER":"","WB4WP_PAGE_FOOTER":"","_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[11],"tags":[22,4,6],"class_list":["post-749","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nghien-cuu-khoa-hoc","tag-duoc","tag-nghien-cuu","tag-study"],"yoast_head":"\n<title>31 thu\u1eadt ng\u1eef c\u1ea7n bi\u1ebft \u0111\u1ec3 \u0111\u1ecdc m\u1ed9t b\u00e0i b\u00e1o nghi\u00ean c\u1ee9u khoa h\u1ecdc - Ph\u1ea7n 1 – Th\u01b0\u01a1ng Library<\/title>\n<meta name=\"description\" content=\"M\u1ed9t s\u1ef1 ki\u1ec7n b\u1ea5t l\u1ee3i \u0111e d\u1ecda \u0111\u1ebfn t\u00ednh m\u1ea1ng, c\u1ea7n 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<\/strong><\/td>	Interpretation<\/strong><\/td><\/tr>
Superiority \u2013 Nghi\u00ean c\u1ee9u v\u01b0\u1ee3t tr\u1ed9i<\/strong><\/td>	Nh\u00f3m can thi\u1ec7p > Nh\u00f3m ch\u1ee9ng<\/strong><\/td><\/tr>
Equivalence \u2013 Nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng<\/strong><\/td>	Nh\u00f3m Can thi\u1ec7p t\u01b0\u01a1ng \u0111\u01b0\u01a1ng nh\u1edbm ch\u1ee9ng<\/strong><\/td><\/tr>
Non \u2013 inferiority<\/strong><\/td>	Nh\u00f3m Can Thi\u1ec7p kh\u00f4ng kh\u00f4ng t\u1ec7 h\u01a1n \u1edf m\u1ee9c kh\u00f4ng ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n V\u00ed d\u1ee5,<\/strong><\/h4>\n\n\n\n M\u1ed9t th\u1eed nghi\u1ec7m c\u00f3 th\u1ec3 so s\u00e1nh hi\u1ec7u qu\u1ea3 c\u1ee7a m\u1ed9t lo\u1ea1i kh\u00e1ng sinh m\u1edbi v\u1edbi m\u1ed9t lo\u1ea1i kh\u00e1ng sinh c\u0169 h\u01a1n. Tuy nhi\u00ean, so s\u00e1nh c\u1ee5 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng s\u1ebd ph\u1ee5 thu\u1ed9c v\u00e0o gi\u1ea3 thuy\u1ebft \u0111\u01b0\u1ee3c gi\u1ea3i quy\u1ebft. H\u00e3y s\u1eed d\u1ee5ng v\u00ed d\u1ee5 v\u1ec1 hai lo\u1ea1i kh\u00e1ng sinh cho cu\u1ed9c th\u1ea3o lu\u1eadn n\u00e0y.<\/p>\n\n\n\n Ch\u00fang ta c\u00f3 th\u1ec3 x\u00e2y d\u1ef1ng 3 gi\u1ea3 thuy\u1ebft c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c gi\u1ea3i quy\u1ebft khi so s\u00e1nh hai lo\u1ea1i kh\u00e1ng sinh n\u00e0y. Ba gi\u1ea3 thuy\u1ebft l\u00e0:<\/p>\n\n\n\n Thu\u1ed1c kh\u00e1ng sinh m\u1edbi \u00edt nh\u1ea5t c\u0169ng t\u1ed1t nh\u01b0<\/strong> thu\u1ed1c kh\u00e1ng sinh c\u0169.<\/li> Thu\u1ed1c Kh\u00e1ng Sinh M\u1edbi t\u1ed1t h\u01a1n<\/strong> Thu\u1ed1c Kh\u00e1ng Sinh C\u0169.<\/li> Thu\u1ed1c kh\u00e1ng sinh m\u1edbi t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi<\/strong> thu\u1ed1c kh\u00e1ng sinh c\u0169.<\/li><\/ol>\n\n\n\n M\u1eb7c d\u00f9 m\u1ed7i gi\u1ea3 thuy\u1ebft n\u00e0y c\u00f3 v\u1ebb gi\u1ed1ng nhau, nh\u01b0ng ch\u00fang l\u00e0 nh\u1eefng c\u00e2u h\u1ecfi khoa h\u1ecdc h\u01a1i kh\u00e1c nhau, do \u0111\u00f3 m\u1ed7i gi\u1ea3 thuy\u1ebft \u0111\u00f2i h\u1ecfi m\u1ed9t th\u1eed nghi\u1ec7m th\u1ed1ng k\u00ea h\u01a1i kh\u00e1c nhau. \u0110\u1ed1i v\u1edbi gi\u1ea3 thuy\u1ebft \u0111\u1ea7u ti\u00ean (\u201c\u00edt nh\u1ea5t l\u00e0 t\u1ed1t nh\u01b0\u201d), Thu\u1ed1c kh\u00e1ng sinh m\u1edbi ph\u1ea3i t\u1ed1t nh\u01b0 Thu\u1ed1c kh\u00e1ng sinh c\u0169, nh\u01b0ng n\u00f3 c\u0169ng c\u00f3 th\u1ec3 t\u1ed1t h\u01a1n Thu\u1ed1c kh\u00e1ng sinh c\u0169.<\/strong><\/p>\n\n\n\n 15. Cross-over trial<\/strong> \u2013 Thi\u1ebft k\u1ebf giao ch\u00e9o<\/strong><\/h3>\n\n\n\n M\u1ed9t th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng trong \u0111\u00f3 c\u00e1c nh\u00f3m t\u00ecnh nguy\u1ec7n vi\u00ean \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n hai ho\u1eb7c nhi\u1ec1u bi\u1ec7n ph\u00e1p can thi\u1ec7p theo m\u1ed9t th\u1ee9 t\u1ef1 c\u1ee5 th\u1ec3. N\u00f3 th\u1ec3 hi\u1ec7n m\u1ed9t s\u1ed1 l\u1ee3i th\u1ebf, ch\u1eb3ng h\u1ea1n nh\u01b0 ph\u01b0\u01a1ng sai th\u1ea5p do \u0111i\u1ec1u tr\u1ecb v\u00e0 ki\u1ec3m so\u00e1t l\u00e0 c\u00f9ng m\u1ed9t ng\u01b0\u1eddi tham gia, v\u00e0 kh\u1ea3 n\u0103ng bao g\u1ed3m m\u1ed9t s\u1ed1 ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb. Tuy nhi\u00ean, gi\u1eefa c\u00e1c giai \u0111o\u1ea1n \u0111i\u1ec1u tr\u1ecb kh\u00e1c nhau ph\u1ea3i c\u00f3 \u0111\u1ee7 kho\u1ea3ng c\u00e1ch th\u1eddi gian (giai \u0111o\u1ea1n r\u1eeda tr\u00f4i\/<\/strong> washout period<\/strong>).<\/strong><\/p>\n\n\n\n V\u00ed d\u1ee5:<\/strong><\/h4>\n\n\n\n Thi\u1ebft k\u1ebf th\u1eed nghi\u1ec7m ch\u00e9o \u201c2×2\u201d l\u00e0 trong \u0111\u00f3 m\u1ed9t nh\u00f3m nh\u1eadn thu\u1ed1c A v\u00e0o \u0111\u1ea7u th\u1eed nghi\u1ec7m v\u00e0 sau \u0111\u00f3 nh\u1eadn thu\u1ed1c B cho ph\u1ea7n c\u00f2n l\u1ea1i c\u1ee7a th\u1eed nghi\u1ec7m. Trong nh\u00f3m th\u1ee9 hai, nh\u1eefng ng\u01b0\u1eddi tham gia nh\u1eadn \u0111\u01b0\u1ee3c thu\u1ed1c B \u0111\u1ea7u ti\u00ean v\u00e0 sau \u0111\u00f3 l\u00e0 thu\u1ed1c A. Do \u0111\u00f3, thu\u1eadt ng\u1eef \u201cch\u00e9o\u201d \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 m\u00f4 t\u1ea3 th\u1ee9 t\u1ef1 m\u00e0 h\u1ecd \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh; v\u00ed d\u1ee5 ban \u0111\u1ea7u l\u00e0 thu\u1ed1c A v\u00e0 sau \u0111\u00f3 l\u00e0 thu\u1ed1c B, ho\u1eb7c ban \u0111\u1ea7u l\u00e0 thu\u1ed1c B v\u00e0 sau \u0111\u00f3 l\u00e0 ma t\u00fay A. T\u1ea5t c\u1ea3 nh\u1eefng ng\u01b0\u1eddi tham gia nh\u1eadn \u0111\u01b0\u1ee3c c\u1ea3 hai lo\u1ea1i thu\u1ed1c trong qu\u00e1 tr\u00ecnh nghi\u00ean c\u1ee9u.<\/p>\n\n\n\n $\"\"$ <\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/toolbox.eupati.eu\/resources\/clinical-trial-designs\/?print=print<\/a><\/p>\n\n\n\n 16. Parallel arm \u2013 Thi\u1ebft k\u1ebf song song<\/strong><\/h3>\n\n\n\n Hai nh\u00e1nh ti\u1ebfn nghi\u00ean c\u1ee9u h\u00e0nh song song, \u0111\u1ed3ng th\u1eddi v\u1edbi nhau.<\/p>\n\n\n\n Trong nghi\u00ean c\u1ee9u c\u00f3 thi\u1ebft k\u1ebf d\u1ea1ng parallel (song song), sau khi ph\u00e2n nh\u00f3m ng\u1eabu nhi\u00ean, m\u1ed7i ng\u01b0\u1eddi tham gia s\u1ebd \u1edf trong nh\u00f3m \u0111i\u1ec1u tr\u1ecb<\/a> \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh c\u1ee7a h\u1ecd trong su\u1ed1t th\u1eddi gian nghi\u00ean c\u1ee9u. Thi\u1ebft k\u1ebf nh\u00f3m song song c\u00f3 th\u1ec3 \u00e1p d\u1ee5ng cho nhi\u1ec1u b\u1ec7nh, cho ph\u00e9p ch\u1ea1y th\u00ed nghi\u1ec7m \u0111\u1ed3ng th\u1eddi \u1edf m\u1ed9t s\u1ed1 nh\u00f3m v\u00e0 c\u00e1c nh\u00f3m c\u00f3 th\u1ec3 \u1edf c\u00e1c \u0111\u1ecba \u0111i\u1ec3m ri\u00eang bi\u1ec7t^{5<\/sup><\/p>\n\n\n\n} $\"\"$ <\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/toolbox.eupati.eu\/resources\/clinical-trial-designs\/<\/a><\/p>\n\n\n\n 17. Factorial Design \u2013 Thi\u1ebft k\u1ebf giai th\u1eeba<\/strong><\/h3>\n\n\n\n M\u1ee5c ti\u00eau c\u1ee7a thi\u1ebft k\u1ebf giai th\u1eeba l\u00e0 gi\u00fap \u0111\u00e1nh gi\u00e1 s\u1ef1 t\u01b0\u01a1ng t\u00e1c, hay t\u00e1c \u0111\u1ed9ng c\u1ed9ng g\u1ed9p c\u1ee7a >= 2 can thi\u1ec7p, khi ri\u00eang l\u1ebb ho\u1eb7c ph\u1ed1i h\u1ee3p. Ch\u1eb3ng h\u1ea1n khi so s\u00e1nh v\u1edbi hi\u1ec7u qu\u1ea3 c\u1ee7a c\u00e1c lo\u1ea1i thu\u1ed1c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng, \u00edt h\u01a1n ho\u1eb7c nhi\u1ec1u h\u01a1n so v\u1edbi c\u00e1c lo\u1ea1i thu\u1ed1c ri\u00eang l\u1ebb. M\u00f4 h\u00ecnh 2×2 l\u00e0 ph\u1ed5 bi\u1ebfn nh\u1ea5t ^{4<\/sup><\/strong><\/p>\n\n\n\n} $\"\"$ <\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/toolbox.eupati.eu\/resources\/clinical-trial-designs\/<\/a><\/p>\n\n\n\n 18. Dosing discontinuation \u2013 Gi\u00e1n \u0111o\u1ea1n li\u1ec1u d\u00f9ng<\/strong><\/h3>\n\n\n\n \u0110i\u1ec3m \/ th\u1eddi gian khi m\u1ed9t b\u1ec7nh nh\u00e2n t\u00ecnh nguy\u1ec7n ng\u1eebng v\u0129nh vi\u1ec5n thu\u1ed1c nghi\u00ean c\u1ee9u v\u00ec b\u1ea5t k\u1ef3 l\u00fd do g\u00ec. \u0110i\u1ec1u n\u00e0y c\u00f3 th\u1ec3 v\u00e0o cu\u1ed1i nghi\u00ean c\u1ee9u ho\u1eb7c tr\u01b0\u1edbc khi k\u1ebft th\u00fac n\u1ebfu b\u1ec7nh nh\u00e2n mu\u1ed1n ng\u1eebng d\u00f9ng thu\u1ed1c v\u00ec m\u1ed9t l\u00fd do n\u00e0o \u0111\u00f3.<\/p>\n\n\n\n 19. Early patient withdrawal (premature withdrawal) – B\u1ec7nh nh\u00e2n r\u00fat kh\u1ecfi nghi\u00ean c\u1ee9u s\u1edbm<\/strong><\/h3>\n\n\n\n Th\u1eddi \u0111i\u1ec3m \/ th\u1eddi \u0111i\u1ec3m b\u1ec7nh nh\u00e2n r\u1eddi kh\u1ecfi cu\u1ed9c th\u1eed nghi\u1ec7m tr\u01b0\u1edbc khi ho\u00e0n th\u00e0nh k\u1ebf ho\u1ea1ch c\u1ee7a d\u00f9ng thu\u1ed1c \u0111i\u1ec1u tra \/ th\u1eed nghi\u1ec7m v\u00e0 t\u1ea5t c\u1ea3 c\u00e1c \u0111\u00e1nh gi\u00e1 (bao g\u1ed3m c\u1ea3 theo d\u00f5i).<\/p>\n\n\n\n 20. Eligibility Criteria \u2013 Ti\u00eau chu\u1ea9n \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n<\/strong><\/h3>\n\n\n\n Nh\u1eefng y\u00eau c\u1ea7u m\u00e0 nh\u1eefng ng\u01b0\u1eddi mu\u1ed1n tham gia v\u00e0o m\u1ed9t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng ph\u1ea3i \u0111\u00e1p \u1ee9ng. Ti\u00eau ch\u00ed \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ( Eligibility Criteria) <\/strong>bao g\u1ed3m c\u1ea3 ti\u00eau ch\u00ed thu nh\u1eadn<\/strong> (Inclusion criteria)<\/strong> v\u00e0 ti\u00eau ch\u00ed lo\u1ea1i tr\u1eeb (Exclusion criteria)<\/strong> v\u00e0 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh trong giao th\u1ee9c. Ch\u00fang c\u00f3 th\u1ec3 bao g\u1ed3m tu\u1ed5i, gi\u1edbi t\u00ednh, ti\u1ec1n s\u1eed b\u1ec7nh v\u00e0 t\u00ecnh tr\u1ea1ng s\u1ee9c kh\u1ecfe hi\u1ec7n t\u1ea1i.<\/p>\n\n\n\n $\"\"$ <\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/www.researchgate.net\/figure\/Eligibility-criteria-employed_tbl1_315972984<\/a><\/p>\n\n\n\n 21. European Medicines Agency<\/strong>– EMA<\/strong><\/h3>\n\n\n\n C\u01a1 quan Y t\u1ebf Ch\u00e2u \u00c2u. M\u1ed9t c\u01a1 quan c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u gi\u00e1m s\u00e1t vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c. <\/p>\n\n\n\n 22. Enrollment – Ghi danh<\/strong><\/h3>\n\n\n\n Th\u1eddi \u0111i\u1ec3m, ho\u1eb7c th\u1eddi \u0111i\u1ec3m, t\u00ecnh nguy\u1ec7n vi\u00ean tham gia phi\u00ean t\u00f2a, sau khi \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1ef1 \u0111\u1ed3ng \u00fd. Thu\u1eadt ng\u1eef t\u01b0\u01a1ng t\u1ef1 c\u0169ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh s\u1ed1 l\u01b0\u1ee3ng ng\u01b0\u1eddi tham gia th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng. <\/p>\n\n\n\n 23. Epoch <\/strong><\/h3>\n\n\n\n Giai \u0111o\u1ea1n d\u1ef1 ki\u1ebfn \u200b\u200bc\u1ee7a c\u00e1c t\u00ecnh nguy\u1ec7n vi\u00ean tham gia th\u1eed nghi\u1ec7m. C\u00e1c epoch \u0111i\u1ec3n h\u00ecnh l\u00e0: x\u00e1c \u0111\u1ecbnh t\u00ednh \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n c\u1ee7a \u0111\u1ed1i t\u01b0\u1ee3ng, lo\u1ea1i b\u1ecf c\u00e1c \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3 (t\u1ee9c l\u00e0 m\u1ed9t kho\u1ea3ng th\u1eddi gian khi c\u00e1c \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3 ng\u1eebng l\u1ea1i), ti\u1ebfp x\u00fac v\u1edbi \u0111\u1ed1i t\u01b0\u1ee3ng \u0111i\u1ec1u tr\u1ecb ho\u1eb7c theo d\u00f5i \u0111\u1ed1i t\u01b0\u1ee3ng sau khi \u0111i\u1ec1u tr\u1ecb k\u1ebft th\u00fac.<\/p>\n\n\n\n $\"\"$ <\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/slideplayer.com\/slide\/3301826\/<\/a><\/p>\n\n\n\n 24. FDA<\/strong> – C\u1ee5c Qu\u1ea3n l\u00fd Thu\u1ed1c V\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3<\/h3>\n\n\n\n M\u1ed9t c\u01a1 quan ch\u00ednh ph\u1ee7 trong B\u1ed9 Y t\u1ebf v\u00e0 D\u1ecbch v\u1ee5 Nh\u00e2n sinh Hoa K\u1ef3 gi\u00e1m s\u00e1t s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng c\u1ee7a Qu\u1ed1c gia b\u1eb1ng c\u00e1ch \u0111\u1ea3m b\u1ea3o r\u1eb1ng thu\u1ed1c cho ng\u01b0\u1eddi v\u00e0 th\u00fa y, v\u1eafc xin, s\u1ea3n ph\u1ea9m sinh h\u1ecdc, thi\u1ebft b\u1ecb y t\u1ebf, m\u1ef9 ph\u1ea9m, th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng, ngu\u1ed3n cung c\u1ea5p th\u1ef1c ph\u1ea9m v\u00e0 b\u1ea5t k\u1ef3 s\u1ea3n ph\u1ea9m n\u00e0o mang l\u1ea1i hi\u1ec7u qu\u1ea3 b\u1ee9c x\u1ea1 an to\u00e0n, hi\u1ec7u qu\u1ea3 v\u00e0 b\u1ea3o m\u1eadt.<\/p>\n\n\n\n $\"\"$ <\/figure>\n\n\n\n Ngu\u1ed3n \u1ea3nh<\/em>: https:\/\/www.fda.gov\/about-fda<\/a><\/p>\n\n\n\n 25. Health Authority- C\u01a1 quan y t\u1ebf<\/strong><\/h3>\n\n\n\n M\u1ed9t c\u01a1 quan y t\u1ebf qu\u1ed1c gia ho\u1eb7c qu\u1ed1c t\u1ebf c\u00f3 th\u1ea9m quy\u1ec1n qu\u1ea3n l\u00fd v\u00e0 \u0111i\u1ec1u ch\u1ec9nh m\u1ed9t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng.<\/p>\n\n\n\n 26. Indication – Ch\u1ec9 \u0111\u1ecbnh<\/strong><\/h3>\n\n\n\n M\u1ed9t c\u0103n b\u1ec7nh, tri\u1ec7u ch\u1ee9ng ho\u1eb7c m\u1ed9t t\u1eadp h\u1ee3p c\u00e1c t\u00ecnh hu\u1ed1ng c\u1ee5 th\u1ec3 l\u00e0m cho m\u1ed9t x\u00e9t nghi\u1ec7m, thu\u1ed1c, th\u1ee7 thu\u1eadt ho\u1eb7c ph\u1eabu thu\u1eadt c\u1ee5 th\u1ec3 \u0111\u01b0\u1ee3c khuy\u1ebfn kh\u00edch. \u0110\u1ed1i v\u1edbi m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb, m\u1ed9t ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec1 c\u1eadp \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb \u0111\u00f3 \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb m\u1ed9t b\u1ec7nh c\u1ee5 th\u1ec3.<\/p>\n\n\n\n 27. Informed consent \u2013 M\u1eabu th\u00f4ng b\u00e1o ch\u1ea5p thu\u1eadn<\/strong><\/h3>\n\n\n\n C\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u s\u1eed d\u1ee5ng s\u1ef1 \u0111\u1ed3ng \u00fd \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o \u0111\u1ec3 gi\u1ea3i th\u00edch th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng cho c\u00e1c t\u00ecnh nguy\u1ec7n vi\u00ean ti\u1ec1m n\u0103ng.<\/p>\n\n\n\n M\u1ee5c \u0111\u00edch c\u1ee7a n\u00f3 l\u00e0 \u0111\u1ec3 b\u1ea3o v\u1ec7 ng\u01b0\u1eddi tham gia. N\u00f3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng khi ai \u0111\u00f3 quan t\u00e2m \u0111\u1ebfn vi\u1ec7c tham gia h\u1ecfi v\u1ec1 nghi\u00ean c\u1ee9u v\u00e0 trong su\u1ed1t qu\u00e1 tr\u00ecnh nghi\u00ean c\u1ee9u, cho \u0111\u1ebfn khi nghi\u00ean c\u1ee9u k\u1ebft th\u00fac. Th\u00f4ng tin n\u00e0y c\u0169ng \u0111\u01b0\u1ee3c vi\u1ebft trong m\u1ed9t t\u00e0i li\u1ec7u, \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 m\u1eabu ch\u1ea5p thu\u1eadn \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o, \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf r\u00f5 r\u00e0ng v\u00e0 d\u1ec5 hi\u1ec3u. <\/p>\n\n\n\n N\u1ebfu m\u1ed9t ng\u01b0\u1eddi quy\u1ebft \u0111\u1ecbnh \u0111\u0103ng k\u00fd tham gia th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, h\u1ecd s\u1ebd k\u00fd v\u00e0o m\u1eabu \u0111\u1ed3ng \u00fd \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o \u0111\u1ec3 x\u00e1c nh\u1eadn r\u1eb1ng h\u1ecd hi\u1ec3u c\u00e1c chi ti\u1ebft c\u1ee7a th\u1eed nghi\u1ec7m v\u00e0 \u0111\u1ed3ng \u00fd tham gia. M\u1eabu ch\u1ea5p thu\u1eadn \u0111\u00e3 th\u00f4ng b\u00e1o kh\u00f4ng ph\u1ea3i l\u00e0 h\u1ee3p \u0111\u1ed3ng v\u00e0 ng\u01b0\u1eddi tham gia c\u00f3 th\u1ec3 r\u00fat kh\u1ecfi b\u1ea3n d\u00f9ng th\u1eed b\u1ea5t k\u1ef3 l\u00fac n\u00e0o v\u00e0 v\u00ec b\u1ea5t k\u1ef3 l\u00fd do g\u00ec. <\/p>\n\n\n\n $\"\"$ <\/figure><\/li><\/ul> C\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u s\u1eed d\u1ee5ng s\u1ef1 \u0111\u1ed3ng \u00fd \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o \u0111\u1ec3 gi\u1ea3i th\u00edch th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng cho c\u00e1c t\u00ecnh nguy\u1ec7n vi\u00ean ti\u1ec1m n\u0103ng. <\/figcaption><\/figure>\n\n\n\n 28. Institutional Review Board – Ban r\u00e0 so\u00e1t th\u1ec3 ch\u1ebf (IRB)<\/strong><\/h3>\n\n\n\n IRB (c\u00f2n \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 \u1ee7y ban \u0111\u1ea1o \u0111\u1ee9c \u0111\u1ed9c l\u1eadp (IEC), h\u1ed9i \u0111\u1ed3ng \u0111\u00e1nh gi\u00e1 \u0111\u1ea1o \u0111\u1ee9c (ERB) ho\u1eb7c h\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c nghi\u00ean c\u1ee9u (REB)) l\u00e0 m\u1ed9t nh\u00f3m c\u00e1c b\u00e1c s\u0129, nh\u00e0 khoa h\u1ecdc, ng\u01b0\u1eddi \u1ee7ng h\u1ed9, nh\u00e0 nghi\u00ean c\u1ee9u v\u00e0 c\u00e1c th\u00e0nh vi\u00ean c\u1ee7a c\u1ed9ng \u0111\u1ed3ng \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u00ednh th\u1ee9c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 xem x\u00e9t v\u00e0 gi\u00e1m s\u00e1t t\u1ea5t c\u1ea3 c\u00e1c nghi\u00ean c\u1ee9u li\u00ean quan \u0111\u1ebfn con ng\u01b0\u1eddi. <\/p>\n\n\n\n IRB \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp \u0111\u1ec3 cung c\u1ea5p gi\u00e1m s\u00e1t \u0111\u1ea1o \u0111\u1ee9c v\u00e0 gi\u1ea3m thi\u1ec3u r\u1ee7i ro cho ng\u01b0\u1eddi tham gia.<\/p>\n\n\n\n 29. Investigational drug – Thu\u1ed1c nghi\u00ean c\u1ee9u<\/strong><\/h3>\n\n\n\n Thu\u1ed1c \u0111ang \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong th\u1eed nghi\u1ec7m; \u0111\u1ecbnh ngh\u0129a n\u00e0y \u0111\u1ed3ng ngh\u0129a v\u1edbi \u201cthu\u1ed1c m\u1edbi nghi\u00ean c\u1ee9u\u201d ho\u1eb7c \u201cs\u1ea3n ph\u1ea9m thu\u1ed1c nghi\u00ean c\u1ee9u\u201d.<\/p>\n\n\n\n 30. Medication number – S\u1ed1 thu\u1ed1c <\/strong><\/h3>\n\n\n\n M\u1ed9t s\u1ed1 duy nh\u1ea5t tr\u00ean nh\u00e3n c\u1ee7a m\u1ed7i g\u00f3i thu\u1ed1c \u0111i\u1ec1u tra \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong th\u1eed nghi\u1ec7m \u0111\u1ec3 ph\u00e2n ph\u1ed1i v\u00e0 theo d\u00f5i thu\u1ed1c. Con s\u1ed1 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o thu\u1ed1c \u0111\u01b0\u1ee3c cung c\u1ea5p \u0111\u00fang s\u1ed1 l\u01b0\u1ee3ng cho c\u00e1c trung t\u00e2m nghi\u00ean c\u1ee9u kh\u00e1c nhau.<\/p>\n\n\n\n 31. Outcome measure \u2013 Ph\u00e9p \u0111o k\u1ebft c\u1ee5c<\/strong><\/h3>\n\n\n\n Trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, m\u1ed9t ph\u00e9p \u0111o t\u1eadp h\u1ee3p \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong \u0111\u1ec1 c\u01b0\u01a1ng v\u00e0 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng c\u1ee7a m\u1ed9t can thi\u1ec7p \u0111\u1ed1i<\/p>\n\n\n\n References & Further Reading<\/strong><\/h2>\n\n\n\n https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm?fr=312.32<\/a><\/li> https:\/\/www.fda.gov\/safety\/reporting-serious-problems-fda\/what-serious-adverse-event<\/a><\/li> https:\/\/clinicaltrials.gov\/ct2\/about-studies\/glossary<\/a><\/li> Ph\u1ea1m Ph\u01b0\u01a1ng H\u1ea1nh, Phan Quang Kh\u1ea3i, Ph\u1ea1m Tr\u1ea7n Thu Trang (2020). S\u00e1ch Th\u1ef1c h\u00e0nh Y h\u1ecdc Th\u1ef1c ch\u00fang, <\/em>Nh\u00e0 xu\u1ea5t b\u1ea3n Thanh Ni\u00ean, H\u00e0 N\u1ed9i.<\/li> https:\/\/toolbox.eupati.eu\/resources\/clinical-trial-designs\/<\/a><\/li> https:\/\/www.scribbr.com\/methodology\/control-group\/<\/a><\/li> https:\/\/slideplayer.com\/slide\/3301826\/ <\/li> C\u00e1c h\u00ecnh \u1ea3nh kh\u00f4ng thu\u1ed9c b\u1ea3n quy\u1ec1n c\u1ee7a Th\u01b0\u01a1ng Library \u0111\u01b0\u1ee3c tr\u00edch d\u1eabn ngu\u1ed3n ngay ph\u00eda d\u01b0\u1edbi \u1ea3nh. C\u00e1c h\u00ecnh \u1ea3nh \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch gi\u00e1o d\u1ee5c. <\/li><\/ol>\n\n\n\n B\u00e0i vi\u1ebft thu\u1ed9c chu\u1ed7i b\u00e0i<\/strong> C\u00e1ch \u0111\u1ecdc b\u00e0i b\u00e1o khoa h\u1ecdc theo phong c\u00e1ch sinh vi\u00ean<\/strong><\/h3>\n\n\n\n\u0110\u1ecdc l\u1ea1i ph\u1ea7n 1:<\/h3>\n\n\n\n \n C\u00e1ch \u0111\u1ecdc m\u1ed9t nghi\u00ean c\u1ee9u khoa h\u1ecdc theo phong c\u00e1ch sinh vi\u00ean (ph\u1ea7n 1)<\/a><\/blockquote><\/iframe>\n<\/div><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">\u0110\u1ecdc l\u1ea1i ph\u1ea7n 2:<\/h3>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-th\u01b0\u01a1ng-library wp-block-embed-th\u01b0\u01a1ng-library\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"L3ZD5zM2tu\"><a href=\"https:\/\/thuonglibrary.com\/nghien-cuu-khoa-hoc\/cach-doc-mot-nghien-cuu-khoa-hoc-theo-phong-cach-sinh-vien-phan-2\/\">C\u00e1ch \u0111\u1ecdc m\u1ed9t nghi\u00ean c\u1ee9u khoa h\u1ecdc theo phong c\u00e1ch sinh vi\u00ean (ph\u1ea7n 2)<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"“C\u00e1ch \u0111\u1ecdc m\u1ed9t nghi\u00ean c\u1ee9u khoa h\u1ecdc theo phong c\u00e1ch sinh vi\u00ean (ph\u1ea7n 2)” — Th\u01b0\u01a1ng Library\" src=\"https:\/\/thuonglibrary.com\/nghien-cuu-khoa-hoc\/cach-doc-mot-nghien-cuu-khoa-hoc-theo-phong-cach-sinh-vien-phan-2\/embed\/#?secret=L3ZD5zM2tu\" data-secret=\"L3ZD5zM2tu\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">\u0110\u1ecdc l\u1ea1i ph\u1ea7n 3:<\/h3>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-th\u01b0\u01a1ng-library wp-block-embed-th\u01b0\u01a1ng-library\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"e5SA43vZ4B\"><a href=\"https:\/\/thuonglibrary.com\/nghien-cuu-khoa-hoc\/cach-doc-mot-nghien-cuu-khoa-hoc-theo-phong-cach-sinh-vien-phan-3\/\">Hazard Ratio (HR) hay T\u1ec9 s\u1ed1 r\u1ee7i ro l\u00e0 g\u00ec<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"“Hazard Ratio (HR) hay T\u1ec9 s\u1ed1 r\u1ee7i ro l\u00e0 g\u00ec” — Th\u01b0\u01a1ng Library\" src=\"https:\/\/thuonglibrary.com\/nghien-cuu-khoa-hoc\/cach-doc-mot-nghien-cuu-khoa-hoc-theo-phong-cach-sinh-vien-phan-3\/embed\/#?secret=e5SA43vZ4B\" data-secret=\"e5SA43vZ4B\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p><strong><em>DISCLOSURE:<\/em><\/strong><\/p><p><em>C\u00e1c th\u00f4ng tin c\u1ee7a b\u00e0i vi\u1ebft ho\u00e0n to\u00e0n d\u1ef1a tr\u00ean hi\u1ec3u bi\u1ebft c\u00e1 nh\u00e2n, tr\u1ea3i nghi\u1ec7m v\u00e0 tham kh\u1ea3o c\u00e1c t\u00e0i li\u1ec7u chuy\u00ean ng\u00e0nh c\u1ee7a Th\u01b0\u01a1ng Library. B\u00e0i vi\u1ebft kh\u00f4ng \u0111\u1ea1i di\u1ec7n cho b\u1ea5t k\u00ec c\u00e1 nh\u00e2n hay t\u1ed5 ch\u1ee9c n\u00e0o kh\u00e1c. Vui l\u00f2ng kh\u00f4ng sao ch\u00e9p th\u00f4ng tin khi ch\u01b0a c\u00f3 s\u1ef1 \u0111\u1ed3ng \u00fd c\u1ee7a Th\u01b0\u01a1ng Library.<\/em><\/p><p><em>N\u1ebfu c\u00f3 g\u00f3p \u00fd v\u1ec1 b\u00e0i vi\u1ebft b\u1ea1n vui l\u00f2ng \u0111\u1ec3 l\u1ea1i l\u1eddi nh\u1eafn t\u1ea1i th\u01b0 m\u1ee5c L\u1eddi nh\u1eafn g\u1edfi. Th\u01b0\u01a1ng Library r\u1ea5t h\u00e2n h\u1ea1nh nh\u1eadn c\u00e1c th\u1eafc m\u1eafc, g\u00f3p \u00fd \u0111\u1ec3 n\u1ed9i dung ch\u1ea5t l\u01b0\u1ee3ng h\u01a1n.<\/em><\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Glossary of Clinical Trial Terms Trong nh\u1eefng l\u1ea7n \u0111\u1ea7u khi ti\u1ebfp x\u00fac v\u1edbi nh\u1eefng b\u00e0i b\u00e1o nghi\u00ean c\u1ee9u, m\u00ecnh ph\u1ea3i m\u1ea5t h\u00e0ng gi\u1edd \u0111\u1ed3ng h\u1ed3 \u0111\u1ec3 v\u1eeba \u0111\u1ecdc, v\u1eeba tra t\u1eeb \u0111i\u1ec3n c\u00e1c thu\u1eadt ng\u1eef n\u00e0y, v\u1eeba t\u00ecm c\u00e1c th\u00f4ng tin \u0111\u1ec3 hi\u1ec3u \u00fd ngh\u0129a c\u1ee7a ch\u00fang. Do \u0111\u00f3, hi … <\/p>\n","protected":false},"author":1,"featured_media":762,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","om_disable_all_campaigns":false,"WB4WB4WP_MODE":"","WB4WP_PAGE_SCRIPTS":"","WB4WP_PAGE_STYLES":"","WB4WP_PAGE_FONTS":"","WB4WP_PAGE_HEADER":"","WB4WP_PAGE_FOOTER":"","_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[11],"tags":[22,4,6],"class_list":["post-749","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nghien-cuu-khoa-hoc","tag-duoc","tag-nghien-cuu","tag-study"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>31 thu\u1eadt ng\u1eef c\u1ea7n bi\u1ebft \u0111\u1ec3 \u0111\u1ecdc m\u1ed9t b\u00e0i b\u00e1o nghi\u00ean c\u1ee9u khoa h\u1ecdc - Ph\u1ea7n 1 – Th\u01b0\u01a1ng Library<\/title>\n<meta name=\"description\" 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