Researchers from Seattle Children's Hospital Provide Details of New Studies and Findings in the Area of Gene Therapy (Development of a Safety Surveillance Plan for the Academic Medicine Sponsor Performing First-in-human Cellular Therapy...).

Předmět:	CHILDREN'S hospitals GENE therapy CELLULAR therapy RESEARCH personnel EDUCATIONAL planning
Zdroj:	Gene Therapy Weekly; 6/27/2024, p1859-1859, 1p
Abstrakt:	Researchers from Seattle Children's Hospital have developed guidelines for the development of a safety surveillance plan for early-phase clinical trials of gene therapy. The researchers emphasize the importance of identifying and characterizing safety signals early in clinical development to protect trial participants. The guidelines address regulatory requirements and governance for safety signal identification and risk assessment. This research was supported by the NIH National Center for Advancing Translational Sciences. [Extracted from the article]
Databáze:	Complementary Index
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