Efficacy Testing as a Primary Purpose of Phase 1 Clinical Trials: Is it Applicable to First-in-Human Bionics and Optogenetics Trials?

American Journal of Bioethics Neuroscience 3 (2):20-22 (2012)
  Copy   BIBTEX


In her article, Pascale Hess raises the issue of whether her proposed model may 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 clinical research trials involving irreversible interventions in the brain.



    Upload a copy of this work     Papers currently archived: 77,985

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

The Research Misconception.Maurie Markman - 2004 - International Journal of Applied Philosophy 18 (2):241-252.
Uncertainty and the ethics of clinical trials.Sven Ove Hansson - 2006 - Theoretical Medicine and Bioethics 27 (2):149-167.
Prudent Precaution in Clinical Trials of Nanomedicines.Gary E. Marchant & Rachel A. Lindor - 2012 - Journal of Law, Medicine and Ethics 40 (4):831-840.


Added to PP

25 (#472,175)

6 months
1 (#485,467)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Fred Gilbert
University of Tasmania