Making Better Drugs for Children with Cancer

Front Matter
......Page 2
Reviewers......Page 10
Acronyms and Abbreviations......Page 12
Contents......Page 14
Executive Summary......Page 16
Introduction......Page 19
Childhood Cancers: Background......Page 20
The Existing Capacity for Developing New Agents Specifically for Childhood Cancers......Page 24
Drug Discovery Screening Services......Page 28
Drug Development Resources......Page 31
Access to Drug Development Resources: RAID......Page 32
Clinical Trials: The Children’s Oncology Group......Page 33
Drug Discovery......Page 34
Preclinical Testing......Page 35
What Is Missing?......Page 36
Delays in Testing Approved Agents in Children
......Page 39
Starting Pediatric Trials Earlier in the Drug Development Process......Page 40
Completing Pediatric Clinical Trials More Quickly......Page 41
The Need to Prioritize Agents for Testing in Children with Cancer
......Page 42
Testing and Labeling of Drugs for Pediatric Use
......Page 43
The Pediatric Rule......Page 44
The 1998 Pediatric Final Rule and the Pediatric ResearchEquity Act of 2003......Page 45
The Pediatric Incentive......Page 46
Recommendations
......Page 49
Leukemias......Page 51
Central Nervous System Tumors and Miscellaneous Intracranial andIntraspinal Neoplasms......Page 52
Lymphomas and Other Reticuloendothelial Neoplasms......Page 53
Malignant Bone Tumors......Page 54
Germ Cell, Trophoblastic, and Other Gonadal Neoplasms......Page 55
References......Page 56