Meeting report: pharmacology in pediatric oncology. Summary of the 10th international expert meeting of the Kind Philipp Foundation for leukemia research, June 10 - 13, 2001 at the Schloss Reisensburg, Günzburg an der donau.

Abstract

The Kind-Philipp foundation invited a group of international experts from academia, industry, and regulatory institutions to discuss aspects of new drug development in pediatric oncology. The current design, conduct and infrastructure of clinical trials in Europe and the United States, recent regulatory changes of drug development, and the impact of the likely availability of more targeted anti-cancer agents on drug development for pediatric cancers were discussed. This included a review of risk factors, surrogate markers, novel targets, and new anti-cancer agents for pediatric cancers. A special effort was made to define the requirements of well performed clinical trials, including target evaluation, trial design, use of pharmacokinetic (PK) studies, surrogate markers, ethical, and statistical aspects. The greater need for collaboration beyond the National level was recognized.