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Efficacy testing as a primary purpose of phase 1 clinical trials: is it applicable to first-in-human bionics and optogenetics trials?

Journal Article


Abstract


  • In her article, Pascale Hess raises the issue of whether her

    proposed modelmay be extrapolated and applied to clinical

    research fields other than stem cell-based interventions in

    the brain (SCBI-B) (Hess 2012). Broadly summarized, Hess’s

    model suggests prioritizing efficacy over safety in phase

    1 trials involving irreversible interventions in the brain,

    when clinical criteria meet the appropriate population suffering

    from “degenerative brain diseases” (Hess 2012). Although

    there is a need to reconsider the traditional phase

    1 model, especially with respect to first-in-human clinical

    trials involving novel technologies, the question arises as

    to whether it is appropriate to advocate for a new model

    that prioritizes efficacy over safety across all phase 1 clini-

    cal research trials involving irreversible interventions in the

    brain.

UOW Authors


  •   Gilbert, Frederic (external author)
  •   Harris, Alex R. (external author)
  •   Kapsa, Robert

Publication Date


  • 2012

Citation


  • Gilbert, F., Harris, A. & Kapsa, R. (2012). Efficacy testing as a primary purpose of phase 1 clinical trials: is it applicable to first-in-human bionics and optogenetics trials?. AJOB Neuroscience, 3 (2), 20-22.

Scopus Eid


  • 2-s2.0-84860321078

Ro Metadata Url


  • http://ro.uow.edu.au/aiimpapers/530

Number Of Pages


  • 2

Start Page


  • 20

End Page


  • 22

Volume


  • 3

Issue


  • 2

Abstract


  • In her article, Pascale Hess raises the issue of whether her

    proposed modelmay be extrapolated and applied to clinical

    research fields other than stem cell-based interventions in

    the brain (SCBI-B) (Hess 2012). Broadly summarized, Hess’s

    model suggests prioritizing efficacy over safety in phase

    1 trials involving irreversible interventions in the brain,

    when clinical criteria meet the appropriate population suffering

    from “degenerative brain diseases” (Hess 2012). Although

    there is a need to reconsider the traditional phase

    1 model, especially with respect to first-in-human clinical

    trials involving novel technologies, the question arises as

    to whether it is appropriate to advocate for a new model

    that prioritizes efficacy over safety across all phase 1 clini-

    cal research trials involving irreversible interventions in the

    brain.

UOW Authors


  •   Gilbert, Frederic (external author)
  •   Harris, Alex R. (external author)
  •   Kapsa, Robert

Publication Date


  • 2012

Citation


  • Gilbert, F., Harris, A. & Kapsa, R. (2012). Efficacy testing as a primary purpose of phase 1 clinical trials: is it applicable to first-in-human bionics and optogenetics trials?. AJOB Neuroscience, 3 (2), 20-22.

Scopus Eid


  • 2-s2.0-84860321078

Ro Metadata Url


  • http://ro.uow.edu.au/aiimpapers/530

Number Of Pages


  • 2

Start Page


  • 20

End Page


  • 22

Volume


  • 3

Issue


  • 2