PMID- 30235536
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200103
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 48
IP  - 3
DP  - 2014 May
TI  - Investigation of the Safety Profiles of Japanese Clinical Trials.
PG  - 308-315
LID - 10.1177/2168479013511622 [doi]
AB  - BACKGROUND: The increasing attrition rates of new drug research and development 
      have become a global problem. To tackle this problem as well as the problem of 
      "drug lag" in Japan, strategies utilizing multiregional clinical trials (MRCTs) 
      are now being commonly applied. It is important to determine whether clinical 
      data in a specific country and region have tendencies or patterns that will help 
      us to consider an appropriate strategy for drug development in the specific 
      region as well as worldwide. However, little has been studied on strategies and 
      methods for drug development to pursue simultaneous development taking into 
      account these characteristics. It would be valuable to determine and characterize 
      the safety profile of Japanese clinical trial data. METHODS: To characterize the 
      overall safety profile of Japanese data in terms of the frequency of adverse 
      events (AEs), serious AEs, and discontinuation due to AEs compared with 
      non-Japanese data, 73 pharmaceutical products recently approved in Japan were 
      selected. Their clinical trial safety data, derived from comparable studies 
      conducted in Japan and Western countries using the bridging strategy and MRCTs, 
      were reviewed and analyzed. RESULTS: Japanese data are similar to non-Japanese 
      data in terms of overall frequency of AEs; however, the sample size of Japanese 
      patients in the bridging studies and MRCTs was generally smaller than that in 
      non-Japanese data. CONCLUSIONS: The safety profile in Japanese clinical data was 
      shown to be similar to that of non-Japanese data from the standpoint of overall 
      frequency of AEs. This finding should be encouraging to pharmaceutical companies 
      and the health authority in Japan to accelerate participation in MRCTs.
FAU - Kanmuri, Kazuhiro
AU  - Kanmuri K
AD  - 1 Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of 
      Pharmaceutical Sciences, Kitasato University, Shirokane, Minato-ku, Tokyo, Japan.
FAU - Narukawa, Mamoru
AU  - Narukawa M
AD  - 1 Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of 
      Pharmaceutical Sciences, Kitasato University, Shirokane, Minato-ku, Tokyo, Japan.
LA  - eng
PT  - Journal Article
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
OTO - NOTNLM
OT  - Japanese data
OT  - adverse events
OT  - characteristics
OT  - clinical trials
OT  - safety profile
EDAT- 2014/05/01 00:00
MHDA- 2014/05/01 00:01
CRDT- 2018/09/22 06:00
PHST- 2018/09/22 06:00 [entrez]
PHST- 2014/05/01 00:00 [pubmed]
PHST- 2014/05/01 00:01 [medline]
AID - 10.1177/2168479013511622 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2014 May;48(3):308-315. doi: 10.1177/2168479013511622.