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Developing a Gene Therapy Clinical Trial: Tips and Tricks

  • Raman Mehrzad
  • Paul Y. LiuEmail author
Chapter

Abstract

Developing a gene therapy trial has its challenges. The Food and Drug Administration (FDA) and the Recombinant DNA Advisory Committee (RAC) are two federal advisory committees that have to approve trials prior to execution. These committees have strict rules and regulations that need to be followed. Moreover, timing is a factor that needs to be factored in as well. The RAC has specific time frames for committee meetings, and due to heavy submission volumes, the FDA has specific timelines for application review. In this chapter, we will give an overview of the FDA and RAC as well as their requirements for Investigational New Drug (IND) submission.

Abbreviations

ERB

Ethic Review Board

FDA

Food and Drug Administration

IEC

Independent Ethics Committee

IND

Investigational New Drug

NIH

National Institutes of Health

RAC

Recombinant DNA Advisory Committee

REB

Research Ethics Board

References

  1. 1.
    FDA. Available at: www.fda.gov.
  2. 2.
  3. 3.
  4. 4.
    National Institution of Health, Office of Science Policy: RAC. Available at: http://osp.od.nih.gov/office-biotechnology-activities/biomedical-technology-assessment/hgt/rac.
  5. 5.
  6. 6.
    The Office of Human Research Protection. Institutional review board guidebook. “Chapter 3, Section A: Risk/benefit analysis.” pp. 1–10.Google Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Department of Plastic Surgery, Rhode Island HospitalThe Warren Alpert Medical School of Brown UniversityProvidenceUSA

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