Revision of European guidelines on clinical investigation of

Revision of
of European
European Guidelines
Guidelines on
on clinical
clinical investigation
investigation of
of
Revision
products: Treatment
medicinal products:
Treatment of
of Asthma
Asthma
medicinal
Antonio Gómez
Gó
Outes 11,, Mª
Mª Luisa
Luisa Suárez
Suá
Gea 11,, Arantxa
Arantxa Sancho
Sancho López
López 22,, Gonzalo
Gonzalo Calvo
Calvo Rojas
Rojas 33
Gómez Outes
Suárez Gea
Antonio
11 División
Divisió
de Farmacología
Farmacologí
Evaluació
Clí
Agencia Española
Españ
de Medicamentos
Medicamentos yy Productos
Productos Sanitarios
Sanitarios (AEMPS),
(AEMPS), Madrid
Madrid
División de
Farmacología yy Evaluación
Evaluación Clínica,
Clínica, Agencia
Española de
22 Departamento
Departamento de
de Farmacología
Farmacologí
Clí
Hospital Puerta
Puerta de
de Hierro
Hierro Majadahonda,
Majadahonda, Madrid
Madrid
Farmacología Clínica,
Clínica, Hospital
33 Departamento
Departamento de
de Farmacología
Farmacologí
Clí
Hospital Clinic,
Clinic,
Barcelona
Farmacología Clínica,
Clínica, Hospital
Clinic, Barcelona
INTRODUCTION
AIM
In order
order to
to help
help applicants
applicants to
to prepare
prepare the
the dossier
dossier for
for aa MAA,
MAA, the
the
In
European Medicines
Medicines Agency,
Agency, prepares
prepares Scientific
Scientific Guidelines.
Guidelines.
European
The Committee
Committee for
for Human
Human Medicinal
Medicinal Products
Products (CHMP)
(CHMP) delegated
delegated these
these
The
tasks in
in different
different Working
Working Parties.
Parties. The
The Efficacy
Efficacy Working
Working Party
Party (EWP)
(EWP) has
has
tasks
been responsible
responsible for
for the
the development
development and
and update
update of
of clinical
clinical scientific
scientific
been
guidelines (Figure
(Figure 1).
1).
guidelines
Figure 1. Process for drafting a guideline
Efficacy Working Party (EWP)
Implementation
Adoption of final guideline for publication
Preparation of final version of guideline
Collection of comments
Preparation of initial draft guideline
Adoption/release for consultation of concept paper
Development of a concept paper
Appointment of Rapporteur/Co-Rapporteur
Selection of topic
RESULTS
To describe
describe the
the update
update of
of the
the European
European guideline
guideline on
on clinical
clinical
To
investigation of
of medicinal
medicinal products
products in
in the
the treatment
treatment of
of asthma
asthma
investigation
(CPMP/EWP/2922/01).
(CPMP/EWP/2922/01).
METHODS
Co-Rapporteurs, from
from Spain
Spain and
and Sweden,
Sweden, were
were appointed
appointed by
by the
the
Co-Rapporteurs,
Committee for
for Proprietary
Proprietary Medicinal
Medicinal Products
Products (CHMP)
(CHMP) Efficacy
Efficacy Working
Working
Committee
Party (EWP).
(EWP). Based
Based on
on the
the complexity
complexity of
of the
the disease,
disease, internal
internal and
and
Party
external experts
experts were
were also
also involved
involved and
and an
an ad-hoc
ad-hoc expert
expert meeting
meeting
external
convened prior
prior to
to starting
starting the
the revision
revision of
of the
the document.
document. The
The following
following
convened
issues were
were considered
considered when
when updating
updating the
the guideline:
guideline:
issues
1) Updated
Updated categorisation
categorisation of
of asthma
asthma patients;
patients;
1)
2) Representativeness
Representativeness of
of the
the population
population studied
studied across
across the
the entire
entire clinical
clinical
2)
development while
while keeping
keeping the
the necessary
necessary assay
assay sensitivity
sensitivity of
of individual
individual
development
studies;
studies;
3) Value
Value of
of “asthma
“asthma control”
control” as
as aa tool
tool for
for assessing
assessing drug
drug efficacy;
efficacy;
3)
4) Value
Value and
and limitations
limitations of
of lung-function
lung-function parameters
parameters in
in drug
drug
4)
development;
development;
5) Reinforce
Reinforce the
the use
use of
of clinical
clinical measurements
measurements (symptoms)
(symptoms) and
and patientpatient5)
reported outcome
outcome measures;
measures;
reported
6) Improved
Improved judgement
judgement of
of the
the contribution
contribution of
of individual
individual drugs
drugs in
in the
the
6)
context of
of the
the stepwise
stepwise therapeutic
therapeutic strategy
strategy in
in asthma;
asthma;
context
7) The
The need
need for
for aa dedicated
dedicated chapter
chapter on
on children,
children, bearing
bearing in
in mind
mind the
the
7)
specificity of
of the
the disease
disease in
in children
children and
and adolescents
adolescents and
and age-related
age-related
specificity
differences in
in drug
drug effects
effects in
in terms
terms of
of both
both safety
safety and
and efficacy.
efficacy.
differences
Figure 2. First step:
step: Concept paper
The first
first step
step included
included the
the elaboration,
elaboration, adoption
adoption and
and consultation
consultation of
of the
the
The
concept paper
paper EMEA/CHMP/EWP/10797/2009
EMEA/CHMP/EWP/10797/2009 (need
(need for
for revision
revision of
of the
the
concept
asthma guideline).
guideline). The
The preliminary
preliminary concept
concept paper
paper was
was circulated
circulated to
to
asthma
interested learned
learned societies
societies and
and patients
patients associations
associations on
on October
October 2009.
2009.
interested
Any organisation
organisation or
or individual
individual was
was allowed
allowed to
to submit
submit comments
comments using
using aa
Any
publicly available
available template.
template. The
The first
first step
step ended
ended on
on 31st
31st January
January 2010
2010
publicly
(see figure
figure 2).
2).
(see
The second
second step
step (ongoing)
(ongoing) includes
includes the
the drafting
drafting of
of the
the guideline
guideline and
and
The
further consultation
consultation and
and adoption.
adoption. AA preliminary
preliminary draft
draft version
version was
was
further
circulated to
to the
the EWP
EWP members
members on
on July
July 2010.
2010. The
The draft
draft revised
revised guideline
guideline
circulated
is expected
expected for
for public
public release
release by
by end
end 2010.
2010.
is
Source: www.ema.europa.eu
CONCLUSIONS
ACKNOWLEDGEMENTS
The update
update of
of European
European guidelines
guidelines on
on clinical
clinical investigation
investigation follows
follows aa well
well established
established
The
public procedure
procedure in
in which
which many
many agents
agents are
are involved
involved (Rapporteurs,
(Rapporteurs, EWP
EWP members,
members, CHMP,
CHMP,
public
internal and
and external
external experts,
experts, interested
interested parties
parties and
and individuals).
individuals).
internal
POSTER: 36
36
POSTER:
Thanks to
to the
the clinical
clinical expert
expert consulted
consulted during
during the
the
Thanks
elaboration of
of this
this draft,
draft, Dr
Dr A.López
A.López Viña,
Viña, Hospital
Hospital
elaboration
Puerta de
de Hierro
Hierro Majadahonda,
Majadahonda, Madrid.
Madrid.
Puerta