Research & Publications
PIONEER Initiative works to expand the inclusion of
children in kidney trials
There are a record number of clinical trials underway in kidney disease to help identify new treatment options for patients. However not including children in these trials is common due to a lack of clarity around the supporting evidence trial developers need. A collaborative group of nephrologists and patient advocates has come together with representatives from the U.S. Food and Drug Administration and the European Medicines Agency to more clearly outline a path to successfully include children in kidney disease trials.
FDA Draft Guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children
Clinical investigations in children are essential for obtaining data on the safety and effectiveness of drugs, biological products, and medical devices in children and to protect children from the risks associated with exposure to medical products that may be unsafe or ineffective. Children are a vulnerable population who cannot consent for themselves and who therefore are afforded additional safeguards when participating in a clinical investigation. Such safeguards are an essential requirement for the initiation and conduct of pediatric investigations as part of a medical product development program. This guidance describes the FDA’s current thinking regarding ethical considerations for clinical investigations of medical products in children.