en
Scientific article
Comment
English

Clinically-driven safety benchmarks

Published inAJOB neuroscience, vol. 3, no. 2, p. 22-23
Publication date2012
Abstract

Enhancing the capacity of preclinical studies to predict efficacy in humans would be a welcome move and its usefulness would reach beyond stem cell-based trials. Such an adaptation, however, would be incomplete as regards the more specific field pf cellular transplantation studies. In addition to concerns regarding predictions of efficacy, preclinical benchmarks aimed at assessing safety also require adaptation –and rethinking- in order to successfully do their work in the area of stem cell-based interventions. For example, hESC-based intervention involve risks that are potentially more durable and cannot be easily tamed through point-in-time validation of preclinical benchmarks. A further example is the concept of purity, which is crucial in the assessment of safety in preclinical drug assessment but cannot simply be transposed to stem cell-based interventions. Rather than true preclinical criteria, such benchmarks should be viewed as proxies intended to assess different components of safety and efficacy in preparing for research with human subjects.

Keywords
  • Research ethics
  • Parkinson's disease
  • Preclinical studies
  • Research with human subjects
  • Stem cells
  • Translational research
Funding
  • Swiss National Science Foundation - Grant CRSI33 125408/1
Citation (ISO format)
BARAZZETTI, Gaia, HURST, Samia, MAURON, Alex. Clinically-driven safety benchmarks. In: AJOB neuroscience, 2012, vol. 3, n° 2, p. 22–23. doi: 10.1080/21507740.2012.666324
Main files (2)
Article (Accepted version)
accessLevelPrivate
Article (Published version)
accessLevelRestricted
Identifiers
ISSN of the journal2150-7759
572views
3downloads

Technical informations

Creation11/15/2012 10:01:00 AM
First validation11/15/2012 10:01:00 AM
Update time03/14/2023 8:02:05 PM
Status update03/14/2023 8:02:05 PM
Last indexation05/02/2024 1:02:21 PM
All rights reserved by Archive ouverte UNIGE and the University of GenevaunigeBlack