Pediatric clinical trials protocols should be designed with input from stakeholders, according to the Clinical Trials Transformation Initiative on antibacterial drugs.

Sponsors should begin planning pediatrics trials in consultation with the FDA and other regulators as early as possible, the CTTI said, in recommendations developed in collaboration with industry, advocates, and regulators.

Discussions over initial pediatric investigative plans could occur while Phase II adult trials are being performed, or earlier in the drug’s development.