Clinical trials

The conduct and regulation of clinical trials in the paediatric population is a topic of increasing importance.

Very few applications for clinical trials in children are received by National Medicine Regulatory Agencies. If medicines are approved without plans for paediatric use, the only option available to health care professionals is to prescribe the adult formulation which may not be safe or effective for a child.

Trials in children can be more complex than adults trials, with different clinical and ethical considerations however, they are critical in ensuring that life saving drugs are available for children.

New guidance on assessing clinical trials in children

Working to improve regulation of medicines for children, regulators from Stringent Regulatory Authorities have developed guidance for assessing clinical trials in children. The guidance document is intended for experienced clinical trial assessors and their agencies who have an interest in improving their capacity to assess trials in paediatric populations.

• Paediatric clinical trials guidance for assessors

Sources for information about standards and best practices of research in children

The following links provide useful information on:

• assessing clinical trial applications;
• review and evaluation of clinical data and reports in marketing applications;
• improving the available information on the use of medicines in children.

• NIH -- Children and clinical studies
• European Medicines Agency
• US Food and Drug Administration -- Pediatrics
• US Food and Drug Administration -- Running clinical trials
• Clinical Investigation of Medicinal Products in the Pediatric Population
• National Cancer Institute
• National Institutes of Health (NIH) -- Clinical trials
• Council for International Organizations of Medical Sciences
• World Medical Association Declaration of Helsinki
• Nuffield Council on Bioethics
• Clinical Trials in Children

Please send suggestions for additions or updates to: pmr_network@who.int