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Review Article
European Reference Networks: Share, Care, and
Cure—Future or Dream?
Rene Wijnen1
Stefan Michał Anzelewicz2
Claus Petersen3
1 Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam,
The Netherlands
2 Department of Surgery and Urology for Children and Adolescents,
Medical University of Gdansk, Pomerania, Poland
3 Department of Pediatric Surgery, Medical School Hannover,
Hannover, Germany
Piotr Czauderna2
Address for correspondence Rene Wijnen, MD, PhD, Department of
Pediatric Surgery, Erasmus MC Sophia, Wytemaweg 80, Rotterdam
3000 CB, The Netherlands (e-mail:
Eur J Pediatr Surg 2017;27:388–394.
► rare diseases
► children
► networking
European Reference Networks (ERNs) are virtual networks that involve healthcare providers
across Europe. The aim of ERNs is to tackle complex or rare diseases and conditions that
necessitate highly specialized treatment, knowledge and resources.
This article summarizes the concept of European Reference Networks in the European Union,
legislation and policy behind ERNs from the standpoint of pediatric surgical specialty. There
are seven ERNs in which pediatric surgeons are involved, four of which are being discussed,
namely ERN PaedCan, eUROGEN ERN, ERN RARE-LIVER and ERNICA. ERNs program is a step
towards improving health care quality, reducing access inequalities, and increasing overall
medical experience and knowledge but its final impact is yet to be determined.
In general, European Union (EU) member states are responsible for the organization, management, financing, and
delivery of health care.1 In certain cases (particularly medical
emergencies and selected elective procedures), however,
patients have the right to access health care services, drugs,
and other medical products in member states than their own,
with the cost being borne by their own health care system.
The Treaty on European Union (TEU)1 and the Treaty on the
Functioning of the European Union (TFEU)1 try to reach the
goal of equity for all patients in the EU. As pediatric health
care professionals, we mostly concentrate on pediatric
patients group.
The most challenging patients in pediatric age group,
specifically in pediatric surgery, are those with rare congenital
or inherited malformations. The highly complex and lowvolume treatments for these patients make it difficult to
compare different results presented at the European Pediatric
Surgical congresses (under auspices of the European Pediatric
Surgeons’ Association [EUPSA]) and other meetings. Moreover,
even within Europe we see large differences between the
national health care systems, which also impact the outcomes,
August 28, 2017
August 30, 2017
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October 4, 2017
like the differences in facilities, medical culture, and exposure.
Especially in the field of rare diseases the European Commission (EC) urges for the best treatments for all European
citizens. This fact, as well as the development of cross-border
health care, lead to the emergence of European Reference
Networks (ERNs). They therefore came up with the idea that
the best specialists from across Europe should join their efforts
to tackle complex or rare medical conditions that require
highly specialized health care—and thus achieve the necessary
concentration of knowledge and resources.
Existing Legislation and Policy behind
European Reference Networks
The necessity of concentration of knowledge and resources
was clearly stated in 2008, when EC adopted a communication2 that presented an overall community strategy to support member states in diagnosing, treating, and caring for EU
citizens with rare diseases. This communication emphasized
the need for European cooperation to ensure sharing of
scarce knowledge and resources, setting an objective of
developing European cooperation, coordination, and regulation for rare diseases.
© 2017 Georg Thieme Verlag KG
Stuttgart · New York
ISSN 0939-7248.
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This idea gained momentum with the coming into force of
the European Act stipulating that cross-border health care is
allowed for all citizens of European member states. It was
realized, however, that especially for rare diseases crossborder exchange should be limited to approved health care
providers with the best infrastructure and results within
Europe, and that this should be allowed only within acknowledged European networks. The directive on the application
of patients’ rights in cross-border health care was adopted on
January 19, 2011, and entered into application on October 25,
2013.3 Article 12 of Directive 2011/24/EU provides “that the
Commission is to support the member states in the development of European Reference Networks (‘Networks’)
between health care providers and centres of expertise in
the member states, in particular in the area of rare diseases.”
The Directive obligated the EC to support the development of
ERNs. Further legal background consists of a commission
delegating decision,4 that lists the criteria and conditions
that health care providers and the ERNs should fulfill, and a
commission implementing decision,5 containing criteria for
establishing and evaluating ERNs, including the exchange
and dissemination of information about the ERNs.
European Reference Networks
These networks of health care providers should aim to
improve quality and safety aspects and access to highly
specialized health care. In most cases this will require
developing a multidisciplinary approach model (involving
different medical specialties). These collaborations have to
Wijnen et al.
bring added value at a European level in terms of improved
knowledge and education, reduction of the high costs, and
more efficient use of resources. In short, a fundamental
principle is that it is the knowledge and experience which
travels, and not the patient. European Reference Networks
are virtual networks, a voluntary collaboration between
health care providers across the EU.
EC has set criteria and conditions that newly formed ERNs
and health care providers wishing to join an ERN must
meet.3 These are (1) patient-centered care and clinical lead,
(2) participation of at least 10 members in a minimum of
8-member countries, (3) strong independent (third party)
assessment, (4) fulfillment of predefined network and members criteria, and (5) endorsement and approval of national
authorities. Six sets of criteria were developed for networks,5
five with general criteria for members of the ERN, and two
with specific criteria for members. The six network criteria
and capacities concern (1) knowledge and expertise to diagnose, follow up, and manage patients; (2) evidence of good
outcomes; (3) multidisciplinary approach; (4)capacity to produce good practice guidelines and to implement outcome
measures and quality control; (5) research, teaching, and
training; and (6) collaboration with all centers of expertise
and other networks. This kind of cooperation may challenge
pediatric surgeons to find new ways of working, and may
create new needs (i.e., virtual services), new culture, and new
skills. For the patients it means that in in the first instance to
go to a national health care provider, who then can seek
advice or treatment from a specific ERN—which is a kind of
clinical virtual care (►Fig. 1).
Fig. 1 Schematic visualization of the place of ERNs in the European health care systems of different countries (Figure courtesy: Helene Le Borge
of the European Commission).
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European Reference Networks
European Reference Networks
Wijnen et al.
Therefore, the ERNs provide a framework for structured
cooperation to maximize cross-country expertise, to join
research projects and clinical trials, and to provide an
opportunity to build top-level translational and basic
research around shared strategies. The ERNs are also responsible for the dissemination of research results, education, and
training activities.
The EC’s call for networks was opened from March to June
2016. The submitted proposals were assessed in the period
from September to November 2016, partly by checking the
documents of all health care providers and auditing some of
them. In December 2016, the 24 ERNs that were approved by
the board of member states were officially installed by the
Commissioner of Health at the third ERN conference in Vilnius.
The first 24 thematic networks include over 900 highly specialized health care units located in more than 300 hospitals of
25 EU countries plus Norway.6 The recognized ERNs and
responsible coordinators are summarized in ►Table 1.
Pediatric surgeons are involved in seven ERNs: ERN on
inherited and congenital abnormalities (ERNICA), ERN on
congenital malformations and rare intellectual disability
(ERN ITHACA), ERN for Pediatric Cancer, hemato-oncology
(ERN PaedCan), ERN on Rare Hepatological Diseases (ERN
RARE-LIVER), ERN on Transplantation in Children (ERN
TRANSPLANT-CHILD), ERN on Rare and Undiagnosed Skin
Disorders (ERN Skin), and ERN on Rare and Complex Urogenital Diseases and Conditions (ERN eUROGEN).
The coming two years—2017 and 2018—are focused on
further implementation of the ERNs. Initial actions and services have to be started that should lead to a partial service
production. In 2018, new health care providers can join the
recognized networks, provided they fulfill the same criteria as
the already recognized health care providers. Consolidation
should be achieved in the years 2019 and 2020, with increasing
numbers of participants and at least one health care provider
attending as a full member or affiliated member of the ERN in
all the 28 EU member countries. Furthermore this period has to
be focused on full service production, continuous monitoring
and performing indicators, and initial outcome assessment.
The EC will evaluate and update the whole program in 2021.
Most of the ERNs will have an advisory board that includes
members of patient’s organizations, who are one of the most
important initiators of this whole program. Moreover, professional and scientific organizations should participate in
Table 1 Names of all European Reference Networks, their thematic issues, and coordinators
Network’s Name
Group of diseases covered by ERN
Bone diseases
L. Sangiori, Bologna (It)
Craniofacial anomalies and ENT disorders
I. Mathijssen, Rotterdam (NL)
Endocrine conditions
A. Pereira, Leiden (NL)
Rare and complex epilepsies
H. Cross, London (UK)
Kidney diseases
F. Schaefer, Heidelberg (Ger)
Genetic tumor risk syndromes
N. Hoogerbrugge, Nijmegen (NL)
Eye diseases
H. Dollfus, Strasbourg (Fr)
Inherited and congenital anomalies
R. Wijnen, Rotterdam (NL)
Respiratory diseases
T. Wagner, Frankfurt (Ger)
Neurological diseases
H. Graessner, Tübingen (Ger)
Skin disorders
C. Bodemer, Paris (Fr)
Solid adult cancers
J. Blay, Lyon (Fr)
ERN EuroBloodNet
Onco-hematological diseases
P. Fenaux, Paris (Fr)
Urogenital diseases
C. Chapple, Sheffield (UK)
Neuromuscular diseases
K. Bushby, Newcastle (UK)
Diseases of the heart
A. Wilde, Amsterdam (NL)
Congenital malformations and
intellectual disability
J. Clayton-Smith (UK)
Hereditary metabolic diseases
M. Scarpa, Wiesbaden (Ger)
ERN PaedCan
Pediatric cancer
R. Ladenstein, Vienna (A)
Hepatological diseases
D. Jones, Newcastle (UK)
Connective tissue and musculoskeletal diseases
M. Mosca, Pisa (It)
Immunodeficiency, autoinflammatory
and autoimmune diseases
A. Cant, Newcastle (UK)
Transplantation in children
P. Jara, Madrid (Esp)
Multisystemic vascular diseases
G. Jondeau, Paris (Fr)
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Wijnen et al.
Fig. 2 ERN-PAEDCAN governance and organization. See for further details.
these advisory boards—as the EUPSA and ESPN (European
Society of Pediatric Nephrology) suggest—and in this way
exert an influence on implementation of ERNs in Europe.
The topics for 2017 include collaboration with the industry (developing an IT platform and a monitoring and assessment system) and collaboration with national networks and
highly specialized centers. The IT platform is under development and consists of two main parts. The first is the
clinical part for online patient management in which webor videoconferencing and virtual clinical meetings are provided. It should also enable exchange of images (radiology
and pathology), diagnostic tests, pictures (genetics, etc.),
clinical information, and patient data. The second part of
the platform concerns collaboration and communication
within and between ERNs.
The fundamental rationale for setting up these ERNs was
to improve health care for patients with rare diseases. That is
also why the patients’ organizations are so involved in the
whole process, and therefore share, care, and cure are still the
main goals, also for the future. It is well recognized, however,
that this requires setting up registries and data—and biobanks, as well as developing guidelines and assessing multicenter research programs. Financial support from the EC and
the separate member states is needed for the coming years. It
is expected that the ERNs have a higher chance to get grants
from, for example, Horizon 2020, Erasmus Plus program, and
EU structural funds. This offers opportunities for pediatric
surgery, which is a field in which funding is not easy, to
participate in these programs.
Patient Involvement in ERN—European
Patient Advocacy Groups
As defined in the EC Delegated Decision,4 ERNs have to
demonstrate that they are patient-centered and empower
patients. Patients and patient organizations, as stated by the
Commission Expert Group on Rare Diseases’ Addendum,7,8
play a critical role in rare disease ERN due to their expertise
in their rare disease. Patients are fully represented and
participate actively in the ERNs through the European
Patient Advocacy Groups (ePAGs), created by EURORDIS in
Europe.9 It is important to emphasize that ePAG membership
is open to all patient organizations, also non-members of
EURORDIS. The role of EPAGs consists, among others, of
contributing to the ERN boards, addressing ethical issues,
transparency in quality of care, and safety standards, and
contributing to research. In the field of rare diseases, the
research becomes more and more patient driven.10
The first call for ERN applications with funding grants was
launched March 16–June 21, 2016. The funding grant
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European Reference Networks
European Reference Networks
Wijnen et al.
available is € 5,000,000 per year for the first 5 years to cover
all approved networks (third Health Program). The ERN
initiative also receives support from other EU funding programs, such as Connecting Europe Facility and Horizon 2020.
ERN PaedCan
The EUROPaedCan officially kicked off on June 29–30, 2017, in
Brussels, Belgium. The pediatric oncology European Reference
Network has been developed thanks to the previous European
Expert Pediatric Oncology Reference Network for Diagnostics
and Treatment (ExPO-r-Net) project. The goal of this ERN is to
improve childhood cancer patients’ outcomes by reducing the
present inequalities in different member states and establishing mechanisms to facilitate movement of information, guidelines, and knowledge rather than that of patients. ERN PaedCan
links pre-existing reference centers inherent to the established
European Clinical Trial Groups (ECTGs). As successful trials
require multinational collaboration and a high level of acceptance by patients,4 such a network enables not only a perfect
way for harmonization but also for accelerating scientific
progress. A 2008 report11,12 from International Society of
Pediatric Oncology (SIOP) Europe (SIOPE) stated that after
EU Clinical Trials Directive was introduced in 2004, clinical
trials for children had been hampered. Networking is one
possibility to overcome this problem. Therefore the main
aim of PaedCan ERN overlaps with a common goal of the
European Society for Pediatric Oncology (SIOPE). SIOPE has
been one of the leaders in addressing health inequalities since
several years. The examples include electoral Manifesto of
2014, SIOPE Strategic Plan—a European Cancer Plan for Children and Adolescents’ and by including this purpose in the EUfunded projects The European Network for Cancer Research in
Children and Adolescents (ENCCA) and PanCare Childhood and
Adolescent Cancer Survivor Care and Follow-Up Studies
The main function of this ERN is to allow information to
travel rather than the patients, as well as to share existing
expertise, through the implementation of virtual tumor
boards. The ERN PaedCan reunites 57 Member Institutions
from 18 European Countries. The Coordinator Healthcare
Provider is St. Anna Children’s Hospital and Children’s Cancer
Research Institute from Vienna, Austria. The project is coordinated by Prof. Ruth Ladenstein, MD, MBA, cPM, and managed by Melanie Brunhofer, MSc. ►Fig. 2 presents the
overview of ERN-PAEDCAN governance and organization.
European Reference Network for Rare and Complex Urogenital Diseases and Conditions (eUROGEN) aims at quicker
specialist evaluation and more equitable access to highquality diagnosis, treatment, and follow up for patients
(both adults and children) who need highly specialized
assessment and surgery. The main objective is to improve
care for patients with rare or low-prevalence complex diseases or conditions, concentrate expertise where capacity
and knowledge are rare, provide access to the most appropriate diagnosis and treatment of certain conditions, and
allow expertise (not the patient) to travel across borders and
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act as a focal point for medical training and research. The
vision of eUROGEN is that it will train the next generation of
surgeons, increase skill levels and improve outcomes. Transfer of knowledge and training to the Member States with less
expertise is a priority for this ERN. Focusing on diagnosis and
treatment and “ensuring continuity of care from childhood
throughout life.”
eUROGEN comprises 3 work streams (WS), each having a
leader with expertise in this field. WS3—rare urogenital
tumors—and WS2—complex functional urogenital conditions
requiring highly specialized surgery—are more related to adult
patients. WS1, rare uro–recto–genital congenital anomalies,
led by Prof. Wout Feitz (Nijmegen, the Netherlands) is especially focusing on children and transition to adulthood. Pediatric surgeons and urologists are organized in this work stream.
The network consists of 29 health care providers in 11
member states. Patient cases are discussed using the IT
platform and toolbox. The collaborative platform, containing
a list of rare urogenital disease areas and highly complex
conditions, is available from March 2017. This allows for
quicker access to the expertise as patients and clinicians
know where to go to find information. Clinical collaboration
platform is available from July 2017. The IT platform also
aims at live streaming of rare urogenital procedures and
highly complex cases. It also enables virtual European MDT
case discussions and virtual MDT expert advice.
One of the main aims of the eUROGEN is achievement of
lifelong urological care.
Patients have reported lack of adequate care, particularly
when transitioning from pediatric to adult urogenital care.
The three WS ensure that as many of the patients as possible
can receive high-quality specialist care from birth through to
the end of life. Processes will be put into place to transfer the
care of these patients from pediatric to adult specialists and
European virtual multidisciplinary team meetings will be
used for case discussions and recommendations for ongoing
care. The patients’ views are that highly specialized urogenital surgery and treatment should take place in a few centers
of excellence by highly trained and experienced consultants
and surgeons. This centralized approach is cost effective and
provides the best possible outcomes, speeding up diagnosis
and improving survival and quality of life.
The role of patient organizations is critical to the successful development of the ERNs and eUROGEN has worked with
several of them to support the structure and the development of the application. Furthermore, EURORDIS initiated
the European Patient Advisory Groups (ePAGs) to support
meaningful patient participation in ERNs, and eUROGEN
looks forward to collaborating with the urogenital ePAG
group over the coming months.
ERN RARE-LIVER is a Europe-wide network for centers of
excellence in the clinical management of rare liver disease in
adults and children. Currently the diseases covered by the
network include autoimmune liver disease (AILD), structural
liver disease, and metabolic/biliary atresia and related diseases. The network aims to improve the standards of care and
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European Reference Networks
European Reference Network for Inherited and Congenital
Anomalies is especially focused on rare diseases of the intestine and the derivatives of the foregut. That is why the Pediatric
Surgeons and Pediatric Gastroenterologists made a joint venture to establish an ERN for these children and advocate
optimal transition to adulthood in this ERN. The mission of
ERNICA is to promote optimal patient care of rare inherited
and congenital digestive tract–related disorders from infancy
to adulthood providing high-quality and accessible education
and supporting research, improving clinical standards and
services, and reducing health inequalities in Europe. The vision
of ERNICA is to provide the best multidisciplinary initial care
for all European patients with rare intestinal diseases throughout their lives regardless of their country of origin.
ERNICA comprises two work streams. WS1, intestinal
anomalies, has two main groups: (a) rare anomalies of the
esophagus (esophageal atresia, achalasia, etc.) and (b) rare
anomalies of the intestine, such as M. Hirschsprung’s disease,
intestinal atresia, congenital enteropathies and motility disorders, chronic intestinal pseudo-obstruction, microvillus
inclusions disease, familial adenomatous polyposis, necrotizing enterocolitis, etc. A separate group is focused especially on intestinal failure/short bowel syndrome, related to
some of these diagnoses. WS2 concerns congenital diaphragmatic hernia and abdominal wall malformations (gastroschisis and omphalocele, respectively).
The focus of the network is defined in especially five work
packages: capacity building and training, standards of care,
e-health, research and fetal medicine, and therapy. The work
package on fetal therapy is installed under the leadership of
gynecologists of European fetal centers and focuses on
malformations of the intestinal tract, urogenital tract and
congenital diaphragmatic hernia, and other anomalies to be
treated during pregnancy.
The coordinator of ERNICA is Rene Wijnen, Erasmus, MC
Sophia Children, Rotterdam, The Netherlands. Furthermore,
more than 20 European pediatric surgeons are involved in
this network at this moment.
Over the last two decades, important contributions were
made at national, European, and international levels to foster
collaboration in rare diseases research. Setting up ERNs for
rare diseases and complex conditions is one of the most
important steps toward this goal.
ERNs are an exciting new form of cooperation at the
European level between health care providers with specialized expertise, with the overall aim of improving care for
patients with rare diseases and complex conditions. All
surgical ERNs aim at improvement of diagnosis, creation of
more equitable access to high-quality treatments, and care of
patients with rare urogenital diseases and complex conditions requiring highly specialized surgery.
ERNs seem to provide an obvious added value to patients
and medical personnel because they ensure proper data
collection, training of health care professionals, virtual MDT
expert advice, and efficient use of research centers and
resources. Due to the fact that ERNs are organized centrally
in a sort of combination between bottom-up and top-down
approach, they possess clear definitions of roles and responsibilities and access and authorizations for use of IT platforms. Undoubtedly the involvement of patients, which
seems to be at various stages of organization between
different ERNS, is crucial to the final success of ERNs.
Management of rare diseases, rare cancers in particular,
poses specific problems including, above all, delays in diagnosis due to poor diagnostic precision and therapeutic mismanagement.13,14 But due to the ERNs being highly organized
with planned coordinators group meetings, it is possible to
establish protocols for interactions between ERNs, exchange
guidelines and best practice, and share experience on what
might decrease mismanagement. What seems crucial is the
fact that reference networks and research consortia need to
improve dissemination of information to potential patients,
the general public, and the primary care community. In order
for the ERNs to work, potential caregivers have to know how to
contact specific ERNs and how to collaborate.
It is too early to determine yet whether ERNs program will
turn out be a successful venture; however, it seems that it is a
step in the right direction aiming to improve health care
quality, reduce access inequalities, and increase overall
medical experience and knowledge in a highly complex
setting of rare and complicated diseases.
Conflict of Interest
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clinical knowledge in rare liver diseases across Europe. Working closely with the clinical centers, doctors, and patients, the
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across Europe, update clinical guidelines to enable standardization of care and to provide patients with relevant highquality information ( The network as well
as the management board is chaired by Dave Jones, Newcastle,
United Kingdom. Today, 29 liver units from 12 European
member states are listed for the ERN “rare-liver.”
First-line diseases, which have an impact on pediatric
surgery, are biliary atresia and choledochal cysts. These
entities are allocated to the pediatric pillar, which is coordinated by Ekkehard Sturm, Tübingen, Germany. Integrating
the initiative “Biliary Atresia and related diseases” into the
rare-liver activities, Claus Petersen, Hannover, Germany, is
actually in charge of the surgically relevant pediatric diseases
Wijnen et al.
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Wijnen et al.
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