On Investigator Initiated Trial _IIT_

							Investigator Initiated Trial (IIT)
A View from Industries




                Dr.M.Iwasaki (Aventis Pharma)

                      The 4th Kitasato-Harvard
 Oct.28, 2003               Symposium            1
  New Movement
      Manual for IIT
              Prof. Ueda’s 2nd Task Force on GCP
              Basis for coming MHLW Notification
              Notification is planned in March ’04
      Educational seminar (ex, JSCO)
      Preparation of a IIT at NCC
      Several proposals to the industries
                         The 4th Kitasato-Harvard
Oct.28, 2003                   Symposium              2
  A Message from Us
      Fundamental support for IIT
              We should take this activity positively
                   As it gives us opportunity to provide more efficient
                    clinical trial methodology to investigators
                   As it gives also investigators opportunity to
                    recognize the real world of “Clinical Studies”
      Need to clarify issues for improvement
      Ready to continue collaboration


                               The 4th Kitasato-Harvard
Oct.28, 2003                         Symposium                        3
  Proposals
      A face to face meeting with the key
       player for IIT
              Clarify uncertainties / issues
              Seek for the way to solve them
      Introduction of a process that enables us
       to check the scientific, ethical and
       administration matters of IITs
              For the better mutual understanding


                          The 4th Kitasato-Harvard
Oct.28, 2003                    Symposium            4