Background Document for Pediatric Oncology Subcommittee Meeting

 

March 17, 2004

Room 1066, 5630 Fishers Lane

Rockville, MD

 

 

 

 

 

 

Document Prepared by:                                                                            Submitted To:

 

Steven Hirschfeld, M.D.                                                                            Johanna Clifford, MS, RN, BSN

HSM 755                                                                                                       HFD 21, Room 1085

1401 Rockville Pike                                                                                   5630 Rockville Pike

Rockville, MD 20857                                                                                 Rockville, MD 20857

 

 

 

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Table of Contents

 

 

1.         Points to Consider ………………………………………………………....Page 1

 

APPENDICES

 

Appendix A. Safety monitoring in clinical studies enrolling children with cancer.

 

1.         HHS Report to Congress Protecting Children in Research

 

2.         FDA Adaptation of Subpart D

 

3.         NIH Guidelines for Research Involving Children

 

4.         Belmont Report

 

5.         Helsinki Declaration

 

6.         ICH E11

 

7.         ICH E6

 

 

Appendix B. Non-clinical data to complement clinical data for pediatric oncology.

 

1.         Animal Imaging

 

2.         Animal Models and Osteoporosis

 

3.         Golub DNA Microarrays

 

4.         Limitations of Animal Models

 

5.         Mice as Drug Models

 

6.         Rat Genome Sequence

 

7.         Science Mouse Standards

 

8.         Scientific and Ethical Considerations of Animal Studies:

The Role of Xenografting in Pediatric Brain Tumors with

Specific Emphasis on Medulloblastoma/Primitive Neuroectodermal

Tumors of Childhood

 

9.         Childhood testing of new agents