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Title: Author: Created Date: 10/20/2004 3:59:31 PM Document presentation format: Company: NUDPH Other titles – PowerPoint PPT presentation

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Title: etc.,etc.

1
?????????

?? ?
????????????

2
????????????????

??????????????
?????????????
???????????
etc.,etc.
?????????
?????????????
???????????
etc.,etc.
3
3E

Efficacy ??
??????
Effectiveness ??
????????
Efficiency ??
????????????????

4
?????????
?????
???
??????
????
???? (?????)
? ? ? ?
??(??)??????
?????
?????
??
????
??????
?????
????
5
????

????
????(????????)
??????
????
?????
??????
???

????
????
????
?????
????
????
????
???
????
Etc.

6
GCP(Good Clinical Practice)

ICH(The International Conference on Harmonization
of Technical Requirements for Registration of
Pharmaceuticals for Human Use)
?????????????(?GCP)
??????
GMP(Good Manufacturing Practice)
GLP(Good Laboratory Practice)

7
?GCP???

???????????
???????????????????????????????
???????????????
????????????????????????
??????????
SOP?????????????
???IRB(???????)
????????????????????????????

8
IRB(Independent Review Board)

??
???????????
5???
?????1????????????????????
?????????????????
????
?????????
?????????????????
?????????

9
??????

??
???????????????????????
?????????????????????????????
???????????????

10
??????(??)

??
??????
?????????
?????????????
?????
???????????
????????????

11
?????????

?????????????????
???????????????????????(?????????)
???????????????
???????????????????????

12
??????

????????????
??????????????

13
??????

???????????????????????????
?????????????????????

14
??????????(CRC)

??
????
?????????????
????????????
??????
???????
????????
????(????)
??????

15
????(??)
GPMP
? ?? ?
?????
??
OR
???? ???
??? ???????
?????
16
????

?????
???????????
??????????(??????)
1020???
?????
????
???? 50100???

17
????(??)

?????
??????
?????????
???? 2001,000???
?????
?????
????????????????
???? 5,00010,000???

18
???????Patient-oriented Outcomes

???
??
?????
???????????
???
?????????
??????
????
??

19
???????(??)

????
????QOL
??????
??
??????????
?????(?????)
?????(???????)

????Cecil???????
20
???????????????
??()
???? ???
??????
?????
??(-)
??()
???? ???
??(-)
21
?????

???? ? ????
??A(??) ? ??B(???)
???? ? ?????(??)

22
RCT????????

??????

23
RCT????????

??????
???????(???)????
???????????

24
RCT????????

??????
???????(???)????
????
????????????????????????????????????

25
???? Randomization

??
??????????????????????
?????????
???
???????? comparability ?????(????????)

26
RCT????????

??????
???????(???)????
????
????????

27
RCT????????

??????
???????(???)????
?????????
??(????????????)
??(??????????????)
?????????(????)

28
RCT????????

??????
???????(???)????
?????????
?????(?????)
???
??????
??????

29
RCT????????

??????
???????(???)????
?????????
?????(?????)
??(????? Placebo)
???????????
???????????????

30
RCT????????

??????
???????(???)????
?????????
?????(?????)
??(????? Placebo)
???????? Compliance(??)
????????????????????????

31
???????????

?????? Simple, non-crossover
??????? Planned crossover
???????? Unplanned crossover
????(??????) Factorial
?????????(???????)
Intention to treat analysis

32
???????????(per protocol)
????
???
???
??
????
??
????
??
??
(??)
(??)
33
Intention to treat analysis
????
???
???
?? ??
?? ??
??
??
??
??
34
Per protocol?Intention to treat???
Per protocol Intention to treat
??? ???
??? ???? ???????
??????? ???? ??????
??????? ???????? ????????
????? ????????? (??) ???????? (????????)
??????? ??????? (????????) ????????????(???????)
????? ?? ??????
35
??