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


























Table of Contents



1. Points to Consider ....Page 1




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