European Union Pediatric Legislation Jeopardizes Worldwide, Timely Future Advances in the Care of Children With Cancer

Pharmaceutical companies are being forced into long-term commitments to clinical trials before efficacy in adults has been demonstrated. Pediatric clinical oncology trials are being driven by regulatory “tunnel vision” and not by therapeutic benevolence, epidemiologic data, or feasibility. As a result, children with cancer are being monopolized for PDCO-triggered, often unfeasible trials that are not always in their best interests and seldom produce useful therapies. Because clinical trials are global, this affects children with cancer worldwide. Until now, carefully worded concerns about these negative consequences have been published in specialty journals. It is time to start a broader debate on how to move forward.