CHILDREN AND CANCER - A PERSPECTIVE FROM THE CANCER-THERAPY EVALUATION PROGRAM, NATIONAL-CANCER-INSTITUTE

The Cancer Therapy Evaluation Program, National Cancer Institute (CTEP , NCI) strongly supports the role of controlled clinical trials in imp roving the care of children with cancer, and particularly the central role that the pediatric Cooperative Groups play in this process. Trend s that threaten the ability to perform these trials include the increa singly limited financial resources available for clinical investigatio ns and the sentiment within some circles that controlled clinical tria ls may be inappropriate for ethical reasons. The inherent risks of acc epting a new therapy without rigorous comparison to existing therapy s trongly support the need for randomized trials with adequate accrual t o answer important therapeutic questions in a timely and reliable fash ion. Retrospective analysis of multiple clinical trials is one method for identifying compelling hypotheses to be tested prospectively. Usin g this method, we have demonstrated the association between doxorubici n dose intensity and positive response and outcome for patients with E wing sarcoma and osteosarcoma, thereby providing direction for the sel ection of important therapeutic questions to be addressed in future cl inical trials for these malignancies.