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Review
. 2008 Feb;55(1):187-209, xi-xii.
doi: 10.1016/j.pcl.2007.10.008.

Good clinical practice and the conduct of clinical studies in pediatric oncology

Susan Devine  1 , Ramzi N Dagher, Karen D Weiss, Victor M Santana
Affiliations
Review

Good clinical practice and the conduct of clinical studies in pediatric oncology

Susan Devine et al. Pediatr Clin North Am. 2008 Feb.

Abstract

This article discusses the principles that guide good clinical practice standards, with particular emphasis on how they to relate to pediatric oncology research and recent efforts at harmonization. The authors review the clinical trials process and the roles of the participants, highlighting the pivotal role of the clinical investigator and the research team, and briefly review the historical aspects of drug development regulations in the United States and the current regulatory paths for pediatric oncology drug development. Where relevant, historical events that underlie many of the regulations and their current applications are described, and practical examples are provided.

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References

    1. Federal Food Drug, and Cosmetic Act (FD&C Act) [September 17, 2007]. 21 USC Chapter 9. http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm and Amendments. http://www.fda.gov/opacom/laws/default.htm#amendments.
    1. Code of Federal Regulations – Title 21, parts 50 and 56; Title 45, part 46.
    1. The Belmont report: ethical principles and guidelines for the protections of human subjects Bethesda (MD): U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1978. http://www.nih.gov/grants/oprr/humansubjects/guidance/belmont.htm. - PubMed
    1. International Conference on Harmonization. 2007. [September 17]. http://www.ich.org.
    1. Murphy SB. The national impact of clinical cooperative group trials for pediatric cancer. Med Pediatr Oncol. 1995;24:279–80. - PubMed

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