Issue

How to access information about drugs with little long-term research

Background

Every new drug used in the treatment of childhood cancer is tested through the Federal Drug Administration (FDA) clinical trial system, first on adults before being tested in children. The adult clinical testing may take several years to complete. After these studies, there is usually significant information on the short term effects of the specific drug before its use in children. The FDA also requires that any significant toxicity that occurs from any drug be reported through "Med Watch," the FDA medical products reporting program. Therefore, if you want to inquire about any late effects associated with any drug, you can contact the Federal Drug Administration for any information they may have. Also, The National Cancer Institute now has a division addressing survivor issues, that includes late toxicities of treatment. The NCI could also be contacted for information. Another source of information would be the national childhood cancer study group that performs the clinical trials on all new drugs used in children with cancer. The two national study groups are: Children's Cancer Group (CCG) or Pediatric Oncology Group (POG). It may also be helpful to check with the institution that treated you to ask if they have any information on the drugs.

Information

The major organizations that can provide you with information on long-term effects of relatively new agents would be:

• Federal Drug Administration
• National Cancer Institute
• Children's Cancer Group or Pediatric Oncology Group

Resources

National Cancer Institute has several ways to obtain information:

• NCI International Cancer Information Center Building 82, Room l23 Bethesda, MD 20892 301-496-4907
• Cancer Net: Web page: gopher.nih.gov//ll/clin/cancernet
• PDQ (Physicians Data Query)
• Cancer Information Service l-800-4-Cancer
• Federal Drug Administration

National Childhood Cancer Study Groups:

• Children's Cancer Group
• Pediatric Oncology Group