Making Better Drugs For Children With Cancer (cancers And Children)

The successes that have been achieved in treating childhood cancers stand as beacons against the less dramatic improvements for adults with cancer. Progress began to accelerate in the 1960s and 1970s, as treatment regimens were built up, primarily by building combinations of chemotherapeutic drugs. However the near absence of research in pediatric cancer drug discovery threatens to halt the progress in childhood cancer treatment achieved during the past four decades. Making Better Drugs for Children with Cancer identifies the major issues to be addressed in developing new agents for childhood cancers, the gaps in research and development, and the steps that have been suggested to move the process forward. This report also makes a new proposal to capitalize on today's science to bring new treatments to children's cancers. 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 Childhood Cancers: Background -- Agents In Use And In Testing For Children With Cancer -- The Existing Capacity For Developing New Agents Specifically For Childhood Cancers -- Putting The Pieces Together -- Delays In Testing Approved Agents In Children -- The Need To Prioritize Agents For Testing In Children With Cancer -- Testing And Labeling Of Drugs For Pediatric Use. Committee On Shortening The Time Line For New Cancer Treatments, National Cancer Policy Board ; Peter C. Adamson ... [et Al.], Editors ; Institute Of Medicine And National Research Council Of The National Academies. Includes Bibliographical References (p. 41-42). Also Available Via The World Wide Web.