The European Commission has put out for consultation draft guidance on paediatric study information to be included in the European Union’s clinical trial database, EudraCT.
The guidance is one of the Commission’s obligations under Regulation (EC) No. 1901/2006 on medicinal products for paediatric use, which took effect across the member states in January 2007.
It includes specifying the information on paediatric clinical trials that should be entered into EudraCT, which information should be made available to the general public, how clinical trial results should be submitted and made public, and the associated responsibilities of the European Medicines Agency (EMEA).
The rationale is to widen the availability of information on the use of medicinal products in the paediatric population and avoid the “unnecessary repetition of studies in the paediatric population which do not add to the collective knowledge”, the Commission explained.
The guidance covers protocol-related information on, and results from, Phase I, II, II and IV clinical trials that incorporate any or all subsets of the paediatric population, regardless of whether the drug concerned has already been approved in the EU.
Trial information must be entered into EudraCT where the study has at least one investigator site in the European Economic Area (EEA) and/or is part of an agreed Paediatric Investigation Plan (PIP). That includes paediatric trials planned, ongoing or completed in any other country (a ‘third’ country), if these trials are part of a PIP.
As regards timing, all interventional trials with at least one site in the EAA must be entered into EudraCT no later than when applications go in to the national competent authorities (NCAs) of the relevant member states.
Trials with at least one site in a third country that are included in an agreed PIP should be logged in the database no later than one month after either the EMEA’s decision on the agreed PIP or the first approval of/positive opinion on the trial by a third country competent authority and/or ethics committee (whichever is later).
Results from paediatric clinical trials should be submitted to the EMEA and the NCA without delay, and no more than six months after the trial has ended, i.e., the time at which the end-of-trial notification should have been filed, whether the trial has been completed, prematurely terminated or suspended (whichever occurs first). A trial will be considered completed following the last visit of the last patient, as foreseen in the latest version of the study protocol.
What to include
Among the protocol-related information to be included in EudraCT are details of the sponsor, source of funding, identification and description of the treatment arms, therapeutic objective, trial design, major endpoints and exclusion criteria. Results-related information must include the interventions, outcomes measures, blinding, statistical methods, protocol deviations, baseline data, outcomes and estimation, adverse events, and a discussion and interpretation of the study results (by the sponsor, if available, as well as the NCA, if available).
All of this information will be accessible through a dedicated public website with a subset of information regularly updated by the EMEA. The stored data will be amenable to user-friendly searching, including full-text and related keywords options. Protocol-related information will be released to the public automatically as soon as validation in EudraCT is completed, and trial results once they have been validated by the EMEA or the relevant NCA.
The draft guideline in its entirety may be downloaded from the website of the Commission’s Enterprise and Industry directorate at http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/new.htm. Comments should be e-mailed to entr-pharmaceuticals @ec.europa.eu by 18 April 2008.
