Bonne pratique clinique

Résumé

L'appellation bonne pratique clinique (ou « bonnes pratiques cliniques ») (BPC), en anglais good clinical practice (GCP) décrit une norme internationale relative à la bioéthique s'appliquant aux essais cliniques réalisés sur des sujets humains. Les BPC sont promues par le Conseil international d'harmonisation des exigences techniques pour l'enregistrement des médicaments à usage humain (CIH) dans une « ligne directrice » (en guideline) sous la référence E6. Bioethics International publie un indicateur sur le niveau d’éthique et les bonnes pratiques des essais cliniques des compagnies pharmaceutiques afin de protéger les participants. Les recommandations de bonne pratique clinique incluent la préservation des droits de l'homme durant les essais cliniques. Elles s'appuient notamment sur les principes de la Déclaration d'Helsinki. Lien externe

ICH E6 (R1) Guid

Source officielle

https://fr.wikipedia.org/wiki/Bonne_pratique_clinique

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Fiber density of collagen grafts impacts rabbit urethral regeneration

Peter Frey, Jeffrey Alan Hubbell, Hans Mattias Larsson, Kalitha Pinnagoda, Elif Vardar, Ganesh Vythilingam

There is a need for efficient and “off-the-shelf” grafts in urethral reconstructive surgery. Currently available surgical techniques require harvesting of grafts from autologous sites, with increased risk of surgical complications and added patient discomfort. Therefore, a cost-effective and cell-free graft with adequate regenerative potential has a great chance to be translated into clinical practice. Tubular cell-free collagen grafts were prepared by varying the collagen density and fiber distribution, thereby creating a polarized low fiber density collagen graft (LD-graft). A uniform, high fiber density collagen graft (HD-graft) was engineered as a control. These two grafts were implanted to bridge a 2 cm long iatrogenic urethral defect in a rabbit model. Histology revealed that rabbits implanted with the LD-graft had a better smooth muscle regeneration compared to the HD-graft. The overall functional outcome assessed by contrast voiding cystourethrography showed patency of the urethra in 90% for the LD-graft and in 66.6% for the HD-graft. Functional regeneration of the rabbit implanted with the LD-graft could further be demonstrated by successful mating, resulting in healthy offspring. In conclusion, cell-free low-density polarized collagen grafts show better urethral regeneration than high-density collagen grafts.

2018

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Screening out irrelevant cell-based models of disease

Gerardo Turcatti

The common and persistent failures to translate promising preclinical drug candidates into clinical success highlight the limited effectiveness of disease models currently used in drug discovery. An apparent reluctance to explore and adopt alternative cell-and tissue-based model systems, coupled with a detachment from clinical practice during assay validation, contributes to ineffective translational research. To help address these issues and stimulate debate, here we propose a set of principles to facilitate the definition and development of disease-relevant assays, and we discuss new opportunities for exploiting the latest advances in cell-based assay technologies in drug discovery, including induced pluripotent stem cells, three-dimensional (3D) co-culture and organ-on-a-chip systems, complemented by advances in single-cell imaging and gene editing technologies. Funding to support precompetitive, multidisciplinary collaborations to develop novel preclinical models and cell-based screening technologies could have a key role in improving their clinical relevance, and ultimately increase clinical success rates.

Nature Publishing Group2016

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