Communication from the Commission — Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006
Date: 2009-02-04
Institutions: European Commission
Subjects: European Medicines Agency, access to information, database, medical research, medicinal product, public health, testing

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(Information)

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

COMMISSION

Communication from the Commission — Guidance on the information concerning paediatric
clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the
information to be made public by the European Medicines Agency (EMEA), in accordance with
Article 41 of Regulation (EC) No 1901/2006

(2009/C 28/01)

1. INTRODUCTION AND SCOPE

Regulation (EC) No 1901/2006 on medicinal products for
paediatric use (1) (hereafter the ‘Paediatric’ Regulation) entered
into force on 26 January 2007. Article 41(3) of the Regulation
requires the Commission to draw up guidance on the nature of
the information on paediatric clinical trials to be entered into
the database of clinical trials (EudraCT (2)), on which informa-
tion shall be made available to the public, on how clinical trials
results shall be submitted and be made public and on the
European Medicines Agency (EMEA)'s responsibilities and tasks
in this regard.

This obligation aims to increase the availability of information
on the use of medicinal products in the paediatric population
and to avoid unnecessary repetition of studies. The information
is aimed at the public which includes lay persons, patients and
families, health professionals, researchers and academics as well
as industry and regulators.

This guidance sets out the nature of the information to be
entered into EudraCT, the information to be made accessible to
the public, the paediatric clinical trial results to be submitted
and made public and on the responsibilities of the EMEA and
related tasks in this context.

results. Such information is to be entered into EudraCT in cases
where the respective paediatric trial has at least one investigator
site in the European Economic Area (EEA), and/or is part of an
agreed Paediatric Investigation Plan (PIP (3)). It concerns paedia-
tric trials planned, ongoing or completed in the EEA and those
that are planned, ongoing or completed in any other country
(‘third countries’) provided these latter trials are included in a
PIP. The status of each paediatric trial will be identified
(e.g. under assessment, authorised or refused, ongoing, prema-
turely ended or completed). This status will be listed for each
Member State.

trial

initiatives

relating to clinical

The EudraCT data fields are for the most part consistent with
international
registries,
e.g. WHO International Clinical Trials Registry Platform (ICTRP)
Journal Editors
and the International Committee of Medical
(ICMJE). Although EudraCT may have additional
the
fields,
convergence of the information to be made public with the
WHO ICTRP facilitates the work of sponsors and researchers
submitting information to different
for different
registries
purposes, and facilitates access to this information.

The information referred to in this guidance comprises paedia-
tric clinical trial protocol-related information and paediatric trial

and
The Commission's Directorate-General
for Enterprise
Industry (DG ENTR) (4) will make available the list of
the
specific data fields to be included in EudraCT, and those to be
made public.

(1) OJ L 378, 27.12.2006, p. 1.
(2) http://eudract.emea.europa.eu/

(3) See point 2, Article 2 of the Paediatric Regulation.
(4) http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm

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2. NATURE OF THE INFORMATION TO BE ENTERED INTO

EUDRACT AND TIMING

However, notwithstanding the above, if

— the

clinical

trial does not
Article 46(1) of the Paediatric Regulation, and

fall within the

scope of

2.1. Nature of the information

The nature of
the required information to be entered into
EudraCT is based on its importance to clinical trials contained
in an agreed PIP. Two sets of information are required:

— paediatric trial protocol related information — supplied
prior to the start of the trial and updated if needed during
the
investigational
medicinal products (IMPs), therapeutic indication, trial popu-
lation, the trial authorisation and the current status of the
trial,

trial describing the

trial protocol,

— paediatric trial results related information — supplied after
the completion of the trial and containing a summary of the
results and conclusions.

2.2. Timing of entering of the information into EudraCT

2.2.1. Protocol related information

All interventional paediatric clinical trials with at least one site
in the EEA are required to be entered into EudraCT no later
than at the time of the valid application for authorisation of a
clinical trial to the National Competent Authorities (NCA).

— it is for objective scientific reasons not possible to submit
the result-related information within six months, which has
been demonstrated by the submitting party,

result-related information for paediatric trials may be submitted
to the EMEA, for entry into EudraCT, at the latest within twelve
months after the trial has ended, whether the trial has been
completed or prematurely terminated, whichever occurs first.

For the purpose of submitting result-related information, a trial
is considered completed when the last visit of the last patient
has occurred, as foreseen in the latest version of the protocol.
This means that, for the purpose of submitting result-related
information for inclusion into EudraCT, open trial extensions,
e.g. for maintenance treatment, are not considered as part of the
trial.

2.2.3. Submission of the information into EudraCT

The sponsor, PIP holder or Marketing Authorisation Holder
(MAH) submits the information electronically to the EudraCT
staging area, once such a staging area is operational.

In the interim,
format.

the information is submitted in electronic

All clinical trials that are included in an agreed PIP should also
be included, whether
the trials are planned, ongoing, or
completed.

3.1. Protocol related information

3. INFORMATION TO BE MADE AVAILABLE TO THE PUBLIC

In particular, all paediatric trials conducted with at least one site
in a third country and included in an agreed PIP, should be
entered into EudraCT no later than one month after, either, the
EMEA decision agreeing a PIP, or, the first approval/positive
opinion of the trial by a third country competent authority
and/or third country ethics committee, whichever is the latest.

The information to be included in EudraCT and to be made
public will include details of the following elements:

— identification of the clinical trial and its protocol,

— sponsor,

— source of funding,

2.2.2. Result related information

— contact point for public use,

should be
Result-related information for paediatric
submitted to the EMEA, for entry into EudraCT, no more than
six months after the trial has ended, whether the trial has been
completed or prematurely terminated, whichever occurs first.

trials

— identification and description of the treatment arms of the

study (IMPs) to be used,

— therapeutic

objective

of

the

trial

(disease

under

investigation),

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— major objectives and endpoints,

3.3. Timing of making information accessible to the public

— trial design including the countries in which it is to be

conducted,

— trial population,

— inclusion/exclusion criteria,

— trial status (per country or region as applicable), and if

refused for ethical reasons the reasons for refusal.

3.2. Results related information

The information to be included in EudraCT and to be made
public should take into account the format for summary of
results set out in the ICE E3 guideline (1).
It will cover the
following elements:

— administrative information and trial identification,

— trial design,

— scientific background and explanation of rationale for the

trial,

— participants in the trial — information on the subject popu-
lation including inclusion exclusion criteria and demo-
graphic information,

— interventions — the treatments used,

— objective(s) of the trial,

— outcome measures,

— randomisation implementation,

— blinding,

— statistical methods,

— patient disposition,

— protocol deviations,

— recruitment,

— baseline data,

— trial interruption,

— outcomes and estimation,

— ancillary analysis,

— adverse events,

— trial termination,

Protocol-related information will be made public automatically,
once the data has been entered into EudraCT and the trial bas
been approved by the NCA concerned. Where a negative
opinion bas been issued by an Ethics Committee, the informa-
tion on the trial will still be published, together with a field indi-
cating the reason for the negative opinion.

Public release of result-related information takes places automa-
tically once this information has been included by the EMEA in
the EudraCT database.

3.4. How information is made public

The information will be made available through a dedicated
information regularly
public website containing a subset of
updated from EudraCT. Appropriate disclaimers will be included
to reflect the stage of regulatory evaluation of the trial.

Studies not registered in EudraCT and for which protocol-related
information is not available, e.g. because the conduct of the
studies predated requirements for inclusion in EudraCT, should
be specifically identified.

Result-related information is not validated prior to its inclusion
into EudraCT. Responsibility for the result-related information
lies with the sponsor, PIP holder or MAH submitting the results.

EudraCT will contain a disclaimer to this effect.

If and when the results are submitted for assessment (e.g. in a
marketing authorisation application), a link to the public assess-
ment report will be made.

4. RESPONSIBILITIES OF THE EMEA AND TASKS IN THIS

REGARD

4.1. The EMEA's responsibilities

The EMEA should:

— make public the protocol-related information on paediatric
clinical trials in accordance with this guideline and the lists
of data fields made public by DG ENTR,

— discussion and interpretation of study results (interpretation
if available and by competent

of trial results by sponsor,
authority, if available),

— make public the result-related information on trials included
in EudraCT and on any paediatric
submitted
according to Article 45 and 46 of the Paediatric Regulation,

studies

— a declaration of the submitting party on liability for the

accuracy of the submitted information.

— coordinate the exchange of information,

(1) http://www.ich.org/

— manage the EudraCT database.

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4.2. The related tasks

The NCAs should:

The responsibility for the initiation of the process, electronic
submission of protocol and result related data, and maintenance
of data lies with:

— the MAH,

in the case of provision of the results of an
authorised medicinal product in accordance with the obliga-
tions in Articles 45 and 46 of the Paediatric Regulation,

— the sponsor of trials referred to by Article 41, whether or

not it is the MAH,

— the PIP addressee.

The EMEA should:

— enter the protocol

information received electronically into

EudraCT,

— enter information concerning the review and oversight of

the paediatric trial,

— exchange information with the EMEA on the studies

submitted,

— enter additional data relating to the review and authorisa-
tion, amendment and end of the trial, to be recorded directly
into EudraCT by the NCAs or by transmission of the infor-
mation from national clinical trial databases.

5. IMPLEMENTATION

— enter into EudraCT the protocol information received elec-
tronically for third-country trials including their authorisa-
tion status and information regarding the end of trial status,

— enter

the result

information received electronically into

EudraCT,

— make public data from the protocol-related and result-

The guidance set out in this Communication applies:

— as regards the protocol-related information, as soon as the

programming of EudraCT has been finalised,

— as regards the result-related information, once the detailed
guidelines for the reporting format have been published and
the related programming has been finalised.

related information in accordance with Section 3.4.

Finalisation of the programming will be publicly announced.