Efficacy Testing as a Primary Purpose of Phase 1 Clinical Trials: Is it Applicable to First-in-Human Bionics and Optogenetics Trials?
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
Learn more about PhilPapers
AJOB Neuroscience 3 (2):20-22 (2012)
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.
|Keywords||Irreversible brain interventions Optogenetics Bionics Phase 1 Clinical trials|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
James A. Anderson & Jonathan Kimmelman (2014). Are Phase 1 Trials Therapeutic? Risk, Ethics, and Division of Labor. Bioethics 28 (3):138-146.
Audrey R. Chapman & Courtney C. Scala (2012). Evaluating the First-in-Human Clinical Trial of a Human Embryonic Stem Cell-Based Therapy. Kennedy Institute of Ethics Journal 22 (3):243-261.
Thomas C. Jones (2005). A Call to Restructure the Drug Development Process: Government Over-Regulation and Non-Innovative Late Stage (Phase III) Clinical Trials Are Major Obstacles to Advances in Health Care. Science and Engineering Ethics 11 (4):575-587.
Insoo Hyun (2010). Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges. Journal of Law, Medicine & Ethics 38 (2):277-285.
Erik Malmqvist, Niklas Juth, Niels Lynöe & Gert Helgesson (2011). Early Stopping of Clinical Trials: Charting the Ethical Terrain. Kennedy Institute of Ethics Journal 21 (1):51-78.
Maurie Markman (2004). The Research Misconception. International Journal of Applied Philosophy 18 (2):241-252.
Sven Ove Hansson (2006). Uncertainty and the Ethics of Clinical Trials. Theoretical Medicine and Bioethics 27 (2):149-167.
Margaret B. Liu (2010). A Clinical Trials Manual From the Duke Clinical Research Institute: Lessons From a Horse Named Jim. Wiley-Blackwell.
Abraham Fuks, Charles Weijer, Benjamin Freedman, Stanley Shapiro, Myriam Skrutkowska & Amina Riaz, A Study in Contrasts: Eligibility Criteria in a Twenty-Year Sample of NSABP and POG Clinical Trials.
Lisa R. Stines & Norah C. Feeny (2008). Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions. Ethics and Behavior 18 (2 & 3):234 – 246.
Jonathan Kimmelman (2007). Clinical Trials and Scid Row: The Ethics of Phase 1 Trials in the Developing World. Developing World Bioethics 7 (3):128–135.
Marcin Waligora (2013). A European Consistency for Functioning of RECs? We Just Lost Our Chance. Journal of Medical Ethics 39 (6):408-409.
Gary E. Marchant & Rachel A. Lindor (2012). Prudent Precaution in Clinical Trials of Nanomedicines. Journal of Law, Medicine & Ethics 40 (4):831-840.
Stanley H. Shapiro, Charles Weijer & Benjamin Freedman, Reporting the Study Populations of Clinical Trials. Clear Transmission or Static on the Line?
Added to index2012-10-10
Total downloads5 ( #525,003 of 1,911,732 )
Recent downloads (6 months)1 ( #458,113 of 1,911,732 )
How can I increase my downloads?