As per the paediatric regulation, which came into force in January 2007, the Commission is required to draw up guidance on the paediatric study information that must be entered in the EU clinical trials database (EudraCT). According to the draft guidance released by the Commission, two sets of information will be required – protocol-related information which describes the protocol, the product involved, the therapeutic indications, aim of the trial, the trial design and population, exclusion and inclusion criteria, and the current status of the trial; and trial results-related information which includes details of outcome measures, randomization, blinding, recruitment, adverse events, trial termination and discussion and interpretation of the study results.
While the protocol-related information will be released automatically once it has been validated in EudraCT, results-related information will be released only after they have been validated by the national authorities or the European Medicines Agency.