1. GS-TS Trn Tnh HinBan nh Gi Vn o c trong nghin cu y sinh hcB Y t

2. Nghin cu lm sngNghin cu lin quan n i tng l con ngi: Nghin cu lin quan bnh nhn (Patient-oriented research) Nghin cu v c ch sinh bnh Nghin cu pp iu tr /can thip iu tr bnh Nghin cu Th nghim lm sng Nghin cu pht trin k thut mi phc v chn on/iu tr Nghin cu dch t hc v hnh vi Kho st phn b bnh tt Kho st cc yu t nh hng n con ngi Cc gii php phng bnh Nghin cu v tnh hnh bnh tt v dch v y t Cc NC xc nh cc gii php hiu qu trong can thip, iu tr v dch v y t 3. Th nghim lm sng Th nghim lm sng l nghin cu tin cu v can thip y sinhhoc can thip hnh vi (nh thuc, phng php iu tr, thit b,hay mt cch mi s dng thuc, pp iu tr hay thit b bit)trn i tng con ngi, nhm xc nh tnh an ton, hiu lc vhiu qu ca can thip y sinh hay can thip hnh vi. Clinical trial as a prospective biomedical or behavioral research study ofhuman subjects that is designed to answer specific questions aboutbiomedical or behavioral interventions (such as drugs, treatments,devices, or new ways of using known drugs, treatments, or devices).Clinical trials are used to determine whether new biomedical orbehavioral interventions are safe, efficacious, and effective(NIH) 3 4. Th nghim lm sngBt k nghin cu no trn i tng con nginhm pht hin hoc xc minh cc tc dng lmsng, dc l hc v/hoc dc lc hc ca snphm nghin cu v/hoc nhm xc nh bt k phnng bt li no i vi sn phm nghin cu, v/hocnhm nghin cu s hp thu, phn b, chuyn hav thi tr sn phm nghin cu vi mc chkhng nh tnh an ton v/hoc hiu qu ca snphm nghin cu. ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1) 4 5. CC GIAI ON TH NGHIM LM SNG PHT TRINTHUC MI 6. o c hc l g? o c hc l mt lnh vc nghin cu cc gi tr o c v qutrnh lp lun v ngha ca cc gi tr o c ny trong thc tin. o c hc bao gm: Vic nhn thc c cc kha cnh thuc v o c trong hot ng thc tin ca chng ta Khm ph ra cc c s lun l cho vic nn hay khng nn lm mt iu g C kh nng a ra cc nh gi v mt o c v i n quyt nh Pht trin cc khun mu thc hnh tt da trn cc c s lp lun 7. o c trong y khoa o c hc y khoa: nghin cu nhng vn y c pht sinhtrong hot ng thc hnh lm sng din ra hng ngy, ch yu tptrung vo cc vn xy ra trong mi quan h gia bc s v bnhnhn Trch nhim o c: thy thuc l ngi bit r nht v do cngha v mang li li ch cho bnh nhn; phi cha tr v khngc lm hi bnh nhn (m hnh o c y khoa gia trng). 8. Tm tt lch s cc hng dn o c trong y hc Nm a imTn1750 BC Hammuraby (Vua Babylon) Lut Hammurabi400 BCHy LpLi Th Hyppocrates551-479 BCTrung QucKhng T: c tnh ca thy thucTh K 1n Li Th Nhp MnTh K 3Do Thi Li Th AsaphTh K 10 IranLi Khuyn cho Thy ThucTh K 12 Ai CpNht Tng cho Thy Thuc1500Nht Bn17 iu lut Enjuin (Rishu) 9. HI THNG LN NG L Hu Trc (1720 - 1791)o lm thuc l mt nhn thut chuyn bo v sinh mngcon ngi, phi lo ci lo ca ngi, vui ci vui ca ngi,ch ly vic cu sng mng ngi lm nhim v ca mnhkhng nn cu li k cng 10. S ra i chnh thc ca o c sinh hc T ng o c sinh hc (bioethics): Nm1927 ln u tin c s dng in do Fritz Jahrch nhng vn khi s dng ng vt thc vt nghin cu 1970 Van Rensselaer Potter s dng vi ngha rng hn cp nhng vn o c trong mi quan h gia sinh hc, mi trng, y hc v nhng gi tr ca con ngi 11. Nhng quy tc o c trong nghin cu(giai on u) 12. o c trong nghin cu y hc Hot ng nghin cu tin b khoa hc ln trong y khoa, Cc khun mu o c khng p ng c cc vn mi pht sinh Mi quan h gia thy thuc v bnh nhn tr nn kh khn v phc tp. Nhng tin b trong y khoa a ra nhu cu v th nghim. Hot ng th nghim thng cn phi c thc hin trn con ngi. 13. Lch s sinh hc hin i 194719541968 1973Nuremberg Hin Thn Cht noPh Thai1956 1962 They1973 TuskegeeWillowbrook decide whoSyphilis StudySchoollives who dies1978 In vitro1981 nh1987 -19901996 baby ngha CHTMang thaiCu Dolly dm 19992002: Netherlands 1998:Jesse Gelsingerlegalizes T bo gc (Gene Rx)Euthanasia 14. Th nghim lm sng Mt thuc mi ra th trng Mt tr c cc tn tin, thi gian: 10 nm 1 t USD 85% ri rng trong qu trnh th nghim 50% qua c phase 3Nature Vol. 477, 24 Sept 2011 15. Th nghim lm sng Tht bi giai on II, III l do Khng chng minh c an ton (safety) Khng chng minh c hiu lc (efficacy)An tonHiu lc 16. Nghin cu trc Th Chin 2 Trc Th Chin II: t ch n Rx hay nghin cu trn ngi Khng c quy trnh chnh thc no nhm bo v cho ngibnh tham gia nghin cu 17. 1947 18. 10 iu lut Nurumberg1. Ngi bnh hon ton t 6. Nghin cu c nhim v bo v nguyn tham gia ngi tham gia trnh tai bin2. Ngi tham gia phi c7. Chun b chu o y cho thng bo v nghin cu nghin cu trnh thng tn, t vong3. Phi da vo kt qu nghin 8. Phi do ngi c y kh cu trn ng vt, s hiu bit nng y hc cao nht v bnh l9. Ngi tham gia c t do 4. Nguy c ca nghin cu phi chm dt nghin cu nu thy c gim thiu khi c thkhng tip tc c5. Khng c lm nu c l do 10. Ngi lm nghin cu phi cho thy t vong hay thng tt chun b chm dt nghin cu l c th xy ra khng trnhnu thy c kh nng lm tn chi cho ngi tham gia 19. Tuyn B Helsinki (i) B quy tc v o c trong cho BS trong nghin cu thc nghim trn ngi do WMA son tho c chp nhn vo thng 6 1964 Helsinki, Phn Lan. Cp nht 6 ln 1975, 1983, 1989, 1996, 2000, 2008 Trin khai t cc iu khon Nurumberg (1947) 20. Tuyn B Helsinki (ii) Nghin cu phi bo v cuc sng, sc kho, s ringt, v phm gi ngi tham gia Theo ng quy nh v NCKH Da trn nghin cu trong PXN v sinh vt C cng nghin cu c xem xt bi hi ngc lp Ch c thc hin bi nhng ngi c nng lcchuyn mn 21. Tuyn B Helsinki (iii) Nguy c v sc chu ng ca ngi bnh khng c vt tri khi so snh vi nhng li ch c c. Khi nghin cu nu nguy c ln hn li ch th phi ngng li Nghin cu ch c th bin minh khi nhng ngi tham gia s c li ch t kt qu nghin cu Ngi tham gia phi t nguyn v c thng bo u v cuc nghin cu Nu l tr em nu nhn thc c cng phi ng tham gia Kt qu tt hay xu phi c cng b chnh xc 22. Hu Nuremberg Tuskegee Syphylis study (1932-1972) Nghin cu din bin t nhin ca giang mai ngi da en Tuskegee Alabama : 399 ngi da en b giang mai timn Macon County bang Alabama v 201 ngi chng. Ngi tham gia c n ung, khm bnh min ph, bohim chn ct khi cht! Khng thng bo bnh tt, khng cho Rx (1947 c PNC) Khng cng bng v li ch v nguy c 1997 TT Clinton xin li nhng ngi cn sng 23. 1997 24. Hu Nuremberg (ii) Willowbrook School study (1963-1966) Tim virus vim gan B cho cc tr bnh tm thn Bo cho BN l tim chng vim gan Ch cho vo trng khi cha m ng cho con tham gia vonghin cu Jewish Chronic Disease Hospital (1963) Kho st v thi ghp: chch t bo ung th cho tr b bnhmn tnh Khng thng bo nghin cu! 25. Hu Nurumberg (iii) S Kin Thalidomide (1962) Thuc an thn gim au rt hiu nghim do Cty Grnenthal Stolberg (Rhineland) a ra th trng 1950 10,000 tr trn 46 nc b d tt bm sinh qui thai do thalidomide c2 ng phn quang hc BS Sn Khoa William McBride (c) v BS Nhi Khoa Widukind Lenz(c) pht hin lin quan thuc d tt BS Frances Oldham Kelsey (FDA) t chi cp php lu hnh chothalidomide Hoa K. 26. Bo Co Belmont, US (1979) 12/7/74 UBQG Bo V Ngi tham gia nghin cu sinh y hc Hoa K thnh lp 1 ban nghin cu Tm nhng nghin tc c bn v o c trong nghin cu Xy dng hng dn thc hin nghin cu theo quy nh o c 27. Bo co Belmont Belmont Report: 18 Apr 1979 27 Jan 1981 B Y t - Gio Dc - An Sinh X Hi Hoa K (B Y T & Phc V Con Ngi [DHHS]) v FDA ban hnh quy ch quy nh rng cn c Hi ng o c C S (IRB) xem xt cc nghin cu y sinh hc. 28. Ba nguyn tc c bn ca bo co Belmont Tn trng c nhn: tnh t ch ca ngi bnh CONSENT FORM bo v ngi b gii hn t ch Li ch:tn trng quyt nh c nhn v bo v h Gia tng li ch/ gim thiu nguy cNGUY C vs LI CH Cng bng: PP CHN BNHNguy c li ch phi phn phi cng bng 29. The International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use Brussel 1990 US (FDA, PhrMA) Chu u (EU, EFPIA) Nht (MHLW, JPMA) Gia tng tnh phi hp trong nghin cu trn th gii. Bo m thuc mi c bo ch an ton & hiu qu Trnh nghin cu trng lp. Gim s dng sc vt th nghim. Gim gi thnh sn phm. 45 hng dn 30. Good Clinical Practice ICH-GCP Nhng hng dn quc t v o c v khoa hc thit k, thc hin, ghi chp, bo co nghin cu c con ngi tham gia. m bo quyn, s an ton v vn ton v th cht ln tinh thn cho ngi tham gia nghin cuph hp vi cc nguyn tc ca tuyn B Helsinki 31. ICH - GCPEfficacy Guidelines (Hng dn v hiu lc)The work carried out by ICH under the Efficacy heading is concerned with the design, conduct,safety and reporting of clinical trials. It also covers novel types of medicines...Quality Guidelines (Hng dn v cht lng)Harmonisation achievements in the Quality area include pivotal milestones such as the conductof stability studies, defining relevant thresholds for impurities.Safety Guidelines (Hng dn v an ton)ICH has produced a comprehensive set of safety guidelines to uncover potential risks likecarcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy 32. http://iecmoh.vn