???????????? UMIN???????????????? 2005.2.2(?), ??

1
????????????UMIN????????????????2005.2.2(?), ??

• ??????????????????
• ?????

2
1990?????????

• 2000 ?????????(?????)
• 2004.6 GSK? Paxil (paroxetine) scandal
• 2004.9. ????????????(ICMJE)
• 2004.10 ????? ?????
• 2004.10 NY WHO Intl CT Registry Platform
  Meeting
• 2004.11 Mexico Ministerial Summit on Health
  Res.
• 2005.1 ????????(IFPMA) ??

???? ???? 2005 21(1) ???????????
3
Statement of NY Workgroup (Oct. 2004)

• Need for global approach to clinical trials
  registration
• Unambiguous identification of trials
• Consensus needed on which trials data timing
  and disclosure of results
• One-stop search portal publicly available
• System that is simple, effective, efficient
• Capacity built where appropriate
• WHO should establish formal process toward a
  global approach
• Appropriate governance
• Collaborative process, involving all interested
  parties
• Existing structures leveraged need for any new
  structures identified
• WHO mindful of ICMJE deadline

4
NY?????????10??

1. Why register / disclose
2. Which trials to register
3. When to register
4. What data - Unique ID
5. What data Trial descriptors
6. When to update
7. What to disclose at completion
8. Register characteristics
9. Ensuring compliance
10. Role for WHO

General agreement / Area requiring further
discussion
5
???????????Priorities / implications

• ??ICMJE?????????
• ??????????
• ??????
• (1) ????????????
• (2) ??
• (3) ?????????

6
(No Transcript)
7
Vickers A, et.al. Controlled Clinical Trials
1998 19 159-66
8
Publication bias

• ??? or ??
• ?????or ??
• ??????????????? 15?10?

??
??
??
?????????? 10?10?
????????
9
? ?

• ???? (altruism)

10
Randomized Controlled Trial (RCT)
population
sample
random sampling
random allocation
500
R N D
statistical analysis
1,000,000
1,000
interprelation
reporting
500
(generalizability)
IZ 65160-10
11
???

• ???????????(public)???????
• ??????????????????????????????????
• ???????????????????? (public goods)

12
?????????(1979)

• Respect for person
• ???? ??????
• 2. Beneficence
• ??
• Non-maleficence
• ???
• Justice
• ??

13
2. ?????????????

• ????????
• (1) ?????
• (2) ?????
• (3) ????????
• (4) ?????
• ?????? one arm trial
• ?????????????
• ????????????????

14
2 ????????

• ??
• ?????
• ????????
• ?????
• (principal investigator)

15
Number of RCT/CCT/MA in Japan
-prospective handsearch project-
?????. ???? 2003 34(4) 210-6
16
Trends in Number of Chiken in Japan
17
Chiken (industry sponsored registration trials)
is a part of clinical trials
Clinical Trials
Chiken
18
Number of Clinical Trials in Japan in 2002
Chiken n350
Clinical trials published n1,500
Review report to be publicized at PMDA web on
approval
(PMDA Pharmaceuticals and Medical Devices Agency)
19
Total number of clinical trials and its
participants in Japan per year

• Number of clinical trial
• Clinical trial (non-Chiken)
• Published RCT 1,000
• Published non-RCT ca 500 ?
• Unpublished CT ?
• Chiken
• Registry to MHLW 350
• total ca
  2,000 ?

Number of trial participants 100 per trial x
2,000 trials 200,000
20
???????????????(2003)

• 
  ATC-DDD/
• ??? generic name ?? 1000/day ???
  ?????
• 1. ?????(amlodipine) ??? 28.7 340?? 1100??
• 2. ???? (famotidine) ??? 25.3 300??
  750??
• 3. ??????? (asprin) ??? 18.9 230??
  53??
• 4. ????? (theophylline) ?? 16.8 200?? 321??
• 5. ????? (pravastatin) ???? 12.6 190??
  1018??

Monthly ??? ??????? 2004???????
21
3. ????????

• 2005.7.1 ???????
• ?????????????(enrolment)??
• 2005.6.30???????????
• (?????????????)
• ???????
• ICMJE?? 2005.9.13???

22
4. ???ID??

• ?? ??????
• UMIN-CTR??????ID??
• WHO????

23
5. ???????????

• ICMJE???
• ID, ???,??, ?????, ?????????,??,
• ??????,???, ?????????
• UMIN-CTR???
• ????????????
• ???PGx
• ??????????????
• ???
• ??????????????????
• ????????????????

24
6. ????????

• ??????6???1?

25
7. ???????????????

• ????????????
• ??????????????????
• ?? ???

26
8. UMIN-CTR???

• ?????UMIN
• ??
• ???????????????
• ??????????
• ????????

27
9. ?????ensuring compliance

• IRB/????????
• ????
• timing ?
• ??
• ???
• ?????????

28
10. WHO???

• Provide
• facilitation
• standards
• developing area capacity
• Avoid
• duplication
• bureaucracy

Fund ?
29
???? 2004.7.13
30
?????? 2004.7.27 (??)
31
???????????? 2005?1??
32
????

• CTR?????????????????
• ????????

• ???????????

• ?????????????

• WHO????