II????? Phase II Clinical Trial - PowerPoint PPT Presentation

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Title:

II????? Phase II Clinical Trial

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II Phase II Clinical Trial Blind Randomized Controlled Clinical Trial – PowerPoint PPT presentation

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Title: II????? Phase II Clinical Trial


1
II????? Phase II Clinical Trial
  • ??????????
  • Blind Randomized Controlled Clinical Trial
  • ??
  • ???????????

2
?????? ??????
??????(IND) ????????? ??????
????
??????
??????????? ????,?????? ?????????
?????? ????,? ?????
3
? ? ? ?
  • ??(Pharmaceutical Product)???????????????,???????
    ??????????????????????
  • ?????(Investigational Product)??????????????????
    ????

4
????
  • ????(Clinical trial) ??????(????????)??????????,
    ????????????????????/??????????????????,??????????
    ????????
  • ????(Protocol)???????????????,????????????,?????
    ??????????????????????????????????????????????

5
? ? ? ?
  • ?????(Informed Consent Form) ???????????????????
    ?????????????????????????????????????????????????
    ??????????????????,???????????????
  • ?????(Ethics Committee,EC)??????????????????????
    ?????????????????????????,?????????,??????????????
    ?????????????????????????????????????

6
? ? ? ?
  • ??????( Adverse Drug Reactions,ADRs)????????????
    ???????????????????????????????????????????????,??
    ????????,?????????????????????????,???????????
  • ????(Adverse Event,AE)??????????????????????????
    ,??????????????
  • ??????(Serious Adverse Event,SAE)???????????????
    ????????????????????????????????????

7
? ? ? ?
  • ???(Monitor)???????????????????????,?????????????
    ?????????
  • ??(Audit)???????????????????????,????????????????
    ?????????GCP????????
  • ??(Inspection)???????????????????????????????????
    ??,?????????????????????????????

8
II????? Phase II Clinical Trial
  • ???????????????????????????????????????,????III???
    ????????????????????????????????????????,??????,??
    ???????????

9
II????????
  • ????????????
  • ?????????????
  • ?????????
  • ???????????????????????????????
  • ????????????????????????

10
????GCP????????
  • ????????,??????,??????,??GCP????????????
    ????????

11
????II?????
  • 1.?????????????????(???????????,State Food Drug
    Administration,SFDA)????
  • 2.???????????????????,GCP????,??????????,?????????
    ?,?????????????????(ICH-GCP)?
  • 3.??????????
  • 4.?????????????,?????????????????
  • 5.??II???????(protocol)???????????(SOP)?
  • 6.??????????????????

12
???????????????
  • II??????????????????????
  • 1??????
  • 2 ?????????????
  • 1985?7?1?????,1998????????1999?5?1??SFDA?????
  • 2002?12????????????
  • 3 ??GCP????1998?3?2???(??),???1999 ?9 ?1 ?
    ?SFDA???
  • 4 WHO GCP????
  • 5 ICH-GCP????
  • ?????????????????????????????????,???????GCP?I
    CH-GCP?
  • 6 ??????????

13
II??????????????
  • 1. ?????????
  • ???????????GCP ?????SFDA?????
  • 2.??????????????????? ?????
  • 3. ???????????????????? ?????? ??
  • 4.???????????????????????????????????????,???????
  • 5.???????????????????????????
  • 6. ????????????????
  • 7 . ?????????????????????????? ??
  • 8. ???????????????????

14
??GCP??????????
  • ??GCP??,???????????????????????????????,
    ?????????????????????????
  • (1) ?????????????
  • (2) ?????????????,???? ??????????????????????????
    ????????,??????????????
  • (3) ?????????,????????????????????????
  • (4) ?????????????????????????????????????????.

15
??GCP??????????(?1)
  • (5) ?????????????????????????????????????
  • (6) ?????????????????????????
  • (7) ??????????????????????????????????????????????
    ???????????
  • (8) ??????????????? ??????????????
  • (9) ????,????????????? ????? ???????? ????????

16
??GCP??????????(?2)
  • (10) ??????????????????????,????????????
  • (11)????????????,??????????
  • (12)??????????????????????????????
  • (13)??????????????????????????????
  • (14)?????????????????????,?????????????????????
  • (15)?????????????????????????????

17
??GCP????????(?3)
  • (16) ???????????(??????)???????????????
  • (17) ?????????????
  • (18) ???????????????
  • (19) ???? ? ??????????
  • (20) ???????????
  • (21) ???????????????,???????????????????
  • (22) ????

18
??????(design of clinical trial)
  • 1.????(controlled clinical trial)
  • 2.???(randomization)
  • 3.???? (blind trial technique)
  • 4.???(placebo)
  • 5.??????(inclusion criteria)
  • 6.??????(exclusion criteria)
  • 7.???????(dosage and administration)

19
??????(?)
  • 8. ????(assessment of responses)
  • 9. ??????(evaluation of adverse drug reactions)
  • 10.?????????(informed consent)
  • 11.?????(patient compliance)
  • 12.?????(assessment of trial size)
  • 13.?????(case reporting forms, CRF)
  • 14.????(data management)
  • 15.????(statistical analysis)
  • 16.????(termination of trial)
  • 17.??????(final report)

20
????????????????
  • ?A,B???????????
  • ?????????(A??B)
  • ???????(A??????B?)
  • ?????????(??????,????)
  • ??????????A?B??????????????????

21
????????????????
  • ?????????(Null hypothesis)???
  • ???A?B????--????????????????(Probability,??)???,
    ?????????P?lt5,??lt1,??A,B??????95????99????????
    ????,??????????
  • ??A??B????????,??????????
  • ?????I???,?????
  • ??0.05,??A??B?????95?????????????,?????????????9
    5?

22
????????????????
  • ??????????????20??????,1-??????
  • ??0.1,1-? 0.9,??????????????,???A??B??
    ???????90
  • ??0.2,1-? 0.8, ??A??B?????80?

23
????????????????
  • I???(?????,?)???? ?0.050.01?
  • ???,?????,????????
  • II???(?????,?)?????0.10.2?
  • ???, 1-???,?????,????????

24
????????????????
  • ??, ??? ?0.05, ????0.2,??????????
  • ????,??????????????????,???????????????
    ??????,???????????,??????????????????

25
??????????(1)
  • 2002?12?SFDA???????????????????????????
    ????????,??????????????????????????????
  • ???????
  • I?????20?30??
  • II????? 100?????????????100?(?????????100?)?
  • III?????300???????????100?(100?),?200?????????
    ??
  • IV????? 2000?,?????

26
???????????(2)
  • 2. ??????,??????,??????

P1(100-P1)P2(100-P2)
n
f(?,?)
(P2-P1)2
n????????? P1???(???)????? P2??????????????? ?
????(???0.05) ?????(???0.10, 1-?0.90)
27
????????????(3)
P1(100-P1)P2(100-P2)
???n
f(?,?)
(P2-P1)2
??P190,P295,?0.05,?0.10
9010955
10.5578
? n
(95-90)2
28
??????
29
??????
  • ?????
  • ???????????????????????
  • ?????????????
  • ???????????????????????
  • ?????(???)
  • ???????????,??????????????????????????
  • ????????,?????????????????

30
???(placebo)
  • 1. ?????(placebo effect)
  • (1)????????????????
  • ????????????????? 35
  • (2)????????? ???????
  • 2. ????????????
  • (1)??????????,?????
  • (2)???????,????????????
  • (3)?????????????
  • (4)???????????

31
????????????
  • 1. ????????????/??????????????
  • 2. ??????????????????????????????????????????????,
    ???????????
  • 3. ??????????????,????????????
  • 4. ???????????????????,????????????????

32
???(Randomization)
  • ???????????????????????????????,??????????????
    ??????????,??????????????????
  • ????????
  • ???
  • ?????
  • ?????--???????

33
???(Randomization)
  • ?????(019)
  • 11 19 15 5 9 0 6 13
    7 2
  • A B B B B A B A B
    A
  • A1 B1 B2 B3 B4 A2 B5 A3 B6 A4
  • 16 1 12 18 4 17 10 8 3
    14
  • B A A B A B A B A
    A
  • B7 A5 A6 B8 A7 B9 A8 B10 A9 A10

34
????(Blind Trial Technique)
  • ????? Single Blind Trial Technique
  • ????? Double Blind Trial Technique
  • ????????? Double-blind,Double-dummy Trial
    Technique

35
?????????????
A?
B?
???
??????
A?
B?
??? 2 B????
??? 1 A????
4
3
?A??
(A???,B??? 14)
?B??
(B???,A??? 23)
36
????????
  • 1. ????????????????,??A??B?????A??B?,??????????
  • 2. ????
  • ????2???,??????????????????,???????
    ?????(CRF)?????(??????)?????????????,???????????
  • 3. ?????(????)
  • 4. ????????,???????????????
  • 5. ????????????

37
??????(Patient compliance)
  • ?????????
  • ??
  • ???????
  • ???????
  • ??????
  • ????
  • ??????,????
  • ????
  • ??????????????1/3

38
??????
  • ???????????4?????
  • ??(Cure)?????????(???)
  • ???????????????
  • ??(Markedly Improvement)??4???
  • ????????
  • ??(Improvement)?2?????????
  • ?? (Failure)??3?????????
  • ???????????????

39
????????????????
40
Karch?Lasagna??????????
  • ?????
  • (1) ??????????????????,??????,???????????????
  • (2) ????????????????
  • (3) ?????????,????????
  • ?????
  • (1) ??????????????????
  • (2) ????????????????
  • (3) ??????????
  • (4) ?????????????????
  • ????
  • (1) ??????????????????
  • (2) ????????????????
  • (3) ?????????????????????? ??
  • ????
  • ?????????????

41
????????????
42
??????????????
43
(No Transcript)
44
??????(SAE)????
  • ?????????????????,???????????????????,?
    ?????????????????????,?????????????

45
??????????(1)
  • ?????
  • ???????????
  • ???????????
  • ???????
  • ???????????
  • ??????????
  • ?????

46
??????????(2)
  • ???????
  • ???
  • ???????????
  • ?????????
  • ??????????
  • ??????????
  • ???????
  • CRF?????

47
??????
  • ??????????
  • ????????????????????????????,?????????,???????????
    ??????????
  • ???????????????????????

48
????????????
  • ??II???????,??????????
  • ??????????????300??
  • ?????????100?,?200?????
  • 2??????????200?,??100?? ???
  • ???????????II???????????,????????????????

49
????????????
  • ??????????????????????
  • ???????????????????????????????????????????????
    ??????
  • ????,???????,??????????????????
  • ???gt2000??
  • ??????,?????????????????????????????????????II????
    ???????

50
??????????(SOP)
  • Standard operating procedure (SOP)
  • ????????????????????????????????????

51
??????????(SOP)
  • ???
  • ????????SDA????????????
  • ????????????????????????????????
  • ??????(????????????????????????????????????????)?
  • ????????????
  • ?????????????????????????????????????
  • ??????????????????,????????????,??????????????????
    ????????,??????

52
????SOP(?1)
  • ???
  • ?????????????????????,??????????????????????
  • ????????
  • ????II??????????????
  • 1) ???GCP??????????????????,?????????????????????
    ??
  • 2) ?????????????????????
  • 3) ?????????GCP??????
  • 4) ?????????????????
  • 5) ????????,????????????

53
????SOP(?2)
  • ???
  • ??????????,??????????????????GCP????????????
  • ???????????,?????????????????????(24?????????),???
    ?????????24?????????
  • ??????????SOP?????
  • ?????????,?????????????????????????????,??????????
    ??????????????????
  • ???????????????????????
  • ??????????????????????
  • ??????????????,????????????

54
????SOP(?3)
  • ???
  • ???????????????????????????,??????
  • ???????????????????????
  • ????????????????,?????????????????,???????????????
    ?????????????????????????????
  • ?????????????????????????????????????
  • ??????????????????,????????????????????
  • ??????????????????????????,???????????????,???????
    ???????????????????????

55
????SOP(?4)
  • ???
  • ????????????????????????????????????,?????????????
    ???24??????????????????????
  • ???????????CRO????GCP??????????????
  • ??????????????????
  • ???????????????????????????,?????????????????
  • ?????????????????????????????????????

56
????SOP(?5)
  • ?????
  • ??????????(??)?????????(??)?????????,?????????????
    ???????????????(????)?
  • ?????????????????????????????????,?????????
  • ???????????????????????????????
  • ?????????????????????????????

57
????SOP(?6)
  • ?????
  • ??????????????????????????????????????
  • ??????????????????????????????,?????????????????,?
    ???????????????????
  • ???????????????????????????
  • ???????????????????????,??????
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