In a one year pilot phase the essential infrastructure for the implementation of the Human Gene Transfer Clinical Trials database has been setup in co-operation with the "Commission of Somatic Genetransfer" (KSG) and the "German Working Group for Genetherapie" (DAG-GT).
The next step will be to design a database structure which will serve the needs of different users. The first data collected during pilot phase is presented in an aggregated form: see diagrams. The current status of registered trials is being updated and will be published stating all relevant study details in the databases second phase.

Basic population:
All trials which, since establishment of the "KSG",
  • have received positive approval and
  • have been initiated or plan initiation

    • number: 30 trials





    		Basic population:
    All trials which, since establishment of the "KSG",
  • have received positive approval and
  • have been initiated or plan initiation

    • number: 30 trials





    		Basic population:
    All trials which, since establishment of the "KSG",
  • have received positive approval and
  • have been initiated or plan initiation

    • number: 30 trials





    		Basic population:
    All trials which, since establishment of the "KSG",
  • have received positi?????a?t?A?¾ve approval and
  • have been initiated or plan initiation

    • number: 30 trials
    Study characteristics
    Number of centres Monocentric13 Multicentric17    n/a0
    Centre Location National21 International3    n/a6
    Randomization non randomized25 randomized5    n/a0
    Blinding not blinded27 blinded1 double blinded2 n/a2
    Gene transfer in vitro15 in vivo13    n/a2
    Vectorsystem viral17 non viral9    n/a4
    Basic population:
    All trials which, since establishment of the "KSG",
  • have received positive approval and
  • have been initiated or plan initiation

    • number: 30 trials


    		Basic population:
    All trials which, since establishment of the "KSG",
  • have received positive approval and
  • have been initiated or plan initiation

    • number: 30 trials





    		Basic population:
    All trials submitted to "KSG" including one trial before "KSG" has been constituted regardless of KSG-appraisal. Multiple entry possible (e. g. initiated and completed).
    number: 63 trials





    		Basic population:
    All trials which, since KSG has been constituted
  • received positive approval and
  • were initiated

    • including 3 trials before foundation of the KSG resp. time of commencement of KSG
    number: 23 trials