ASSESSING THE EXISTING CAPACITIES AND CURRENT PRACTICES OF ECRIN NEW NETWORKS
PORTUGAL
Date of preparation: February, 2013
Work package 2: Capacity Building
Portugal Members: Emilia Monteiro, Pedro Caetano, Ana Pais
Faculdade de Ciências Médicas - Universidade Nova de Lisboa
I.
INTRODUCTION ........................................................................................................................... 3
II.
METHODOLOGY .......................................................................................................................... 5
III.
GLOBAL OVERVIEW ................................................................................................................. 6
IV.
RESULTS .................................................................................................................................. 7
1.
1.1.
Types of Medicinal Product .............................................................................................. 7
1.2.
Clinical Trial Development Phase ..................................................................................... 7
1.3.
Type of Clinical Trial ......................................................................................................... 8
1.4.
Therapeutic Areas............................................................................................................ 8
2.
NON-INTERVENTIONAL CLINICAL RESEARCH ........................................................................ 9
2.1.
Type of therapy ............................................................................................................... 9
2.2.
Therapeutic Areas (non-interventional) ......................................................................... 10
2.3.
Type of Clinical Study (non-interventional)..................................................................... 10
3.
NON-INTERVENTIONAL
AND
INTERVENTIONAL CLINICAL RESEARCH .......................... 11
3.1.
Interventional Studies vs Observational studies .......................................................... 11
3.2.
International Trials and National Trials ....................................................................... 11
3.3.
Status of the Sponsor ..................................................................................................... 12
3.4.
Design of clinical trials................................................................................................... 12
3.5.
Sponsorship ................................................................................................................... 12
3.6.
Years of Experience in Clinical Research ......................................................................... 13
3.7.
Services already offered by each Clinical Research Institution ........................................ 13
3.8.
Number of Personnel Involved by center in clinical trials ............................................... 14
4.
ORGANIZATION OF THE NATIONAL BODIES IN CHARGE OF CLINICAL RESEARCH ................ 15
5.
PRIVATE FUNDING OPPORTUNITIES FOR THE DEVELOPMENT OF CLINICAL TRIALS ............. 16
6.
PUBLIC FUNDING OPPORTUNITIES FOR THE DEVELOPMENT OF CLINICAL TRIALS ............... 17
7.
STRUCTURE OF THE NATIONAL NETWORK PtCRIN ............................................................. 18
7.1.
V.
INTERVENTIONAL CLINICAL RESEARCH ................................................................................ 7
Centers of the National Network ................................................................................... 19
CONCLUSION ............................................................................................................................ 20
Annex 1: Questionnaire sent to the institutions/centres.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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I.
INTRODUCTION
ECRIN (European Clinical Research Infrastructures Network) is an ESFRI (European Strategy Forum on
Research Infrastructures) European wide infrastructure. It supports multinational clinical research,
aimed at making Europe a single area for clinical studies, taking advantage of population size to recruit
patients, and unlocking latent scientific potential across the continent. By 2013 ECRIN will move from a
network project concept to have an ERIC status (European Research Infrastructure Consortium). ERIC´s
sustainability arises from the contribution and commitment of Member States. ECRIN-ERIC will be in
charge of supporting multinational clinical trials in Europe, an activity which ECRIN has been promoting
for several years.
Furthermore, the FP7-funded (Seventh Framework Programme) ECRIN-IA (Integrating Activity) project
which started in 2012 has an objective of further structuring the network and its user communities.
ECRIN-IA is designed to improve partnerships and capacities, with five main objectives:





Expanding the network and strengthening its national partners
Creating a common European culture among professionals and patient communities
Supporting cross-border connection of research networks
Further developing data management and monitoring tools for multinational trials
Making funding available for multinational clinical research projects
PtCRIN aims to become Portugal’s national hub for planning, setting up and increasing performance
standards of Clinical Research. Its emphasis is on clinical trials, particularly investigator-driven trials
and transnational studies.
PtCRIN is a founding member of ECRIN-ERIC, which from 2013 on will adopt the European Research
Infrastructure Consortium status (hereinafter "ERIC,” see www.ecrin.org). ERIC status is a legal entity
model established by Council Regulation (EC) n° 723/2009 of 25 June 2009. PtCRIN members include
13 of Portugal’s most important hospitals and research centers. PtCRIN desires to provide a strong
contribution to bring Portugal to the forefront of European clinical research within five years. This
contribution will be achieved by improving the Country’s capacity to perform high-quality clinical trials
and, also, by promoting collaboration within the Portuguese clinical research community around the
most innovative European clinical trials.
PtCRIN (http://web.fcm.unl.pt/ptcrin/) intends to fill a serious gap in Portugal’s innovation system.
Clinical research is a key final step to make research and development to come to fruition. While the
country has built a significant capacity in basic science, with emphasis in health research at molecular
and preclinical level, it has not been able to fully integrate its medical and health professional’s
community in this progress. Thus, due to the absence of interaction with a strong clinical research
community, Portuguese basic health research has not delivered meaningful clinical contributions,
immediately useful for patients and public health.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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As such the main mission of PtCRIN is developing and organizing Portuguese clinical research
infrastructures and capacity into a pattern of ever increasing attractiveness and international
competitiveness in innovation and quality.
In order to fulfill our mission PtCRIN will:
• Support and link infrastructures nationally, with exchanges between these infrastructures;
• Intermediate and support national and international multi-centre studies;
• Promote a high-quality and nationally harmonized study culture, e.g., by providing education and
training;
• Implement quality standards, i.e. definition and implementation of internationally recognized quality
standards for the conduct of studies;
• Promote the involvement of Portuguese clinical research in international networks;
• Promote the transfer of knowledge between basic research and therapeutic applications;
• Build bridges between health units, academia, industry and the authorities, as well as trade
organizations and professional associations.
The first task of the above mission was to identify Portuguese research capacities in order to improve
the existing infrastructures and capacities for clinical trials. The first step was achieved with the help of
the “Assessing the existing capacities and current practices” questionnaire which was sent to the
Portuguese centre.
This preliminary report collects the answers from the Portuguese health institutions performing clinical
trials and national authorities (INFARMED) presenting an overview of our network and its capacities.
PtCRIN believes that this network is important for the clinical research field because it will facilitate
communication in-between Portuguese clinical research centers and with Europe.
This report results will also be used in the preparation of the PtCRIN Strategic Plan, since its findings
about each organization and the network, namely strengths and weaknesses, will be used to fill the
gaps and determine which services are most needed in the future. The survey was an excellent tool to
disseminate information about ECRIN and PtCRIN, its missions and objectives in multinational
academic clinical trials.
Concerns about the quality data can be raised, e.g. services available in the centers, and more details
questionnaire will be forward implemented. Finally, this survey will be used at an international level to
establish a compare with other ECRIN hubs.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and
current practices.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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II.
METHODOLOGY
The survey was prepared by ECRIN and sent to the all Portuguese health centers with ongoing
interventional clinical trials1; the cut-off was 4 ongoing clinical trials per center. These Health centers
represent 990 ongoing clinical trials of a total 1109 ongoing clinical trials during 2011 year, according
to INFARMED data.
This also represents a significant part of all Portuguese hospitals. According to the Ministry of Health
(ACSS) in Portugal there are 101 hospitals organized around 27 hospital centers.
The survey was sent to 14 Hospitals Centers (which represent +/- 57 public hospitals2); 8 Individual
Public Hospitals; 2 Universities; 4 Institutes; 2 Private Hospitals; 2 Private Organizations; 1 Primary Care
Unit and 1 Foundation. A total of 34 Health centers/Institutions Administrations Boards (representing
(±) 77 individual health institutions). See table 1.
Type of institution
Hospitals Centers
Individual Public Hospitals
Universities
Institutes
Number of Institutions Administrations
Boards
14
8
2
4
Number of individual health institutions
57
8
2
4
Private Hospitals
2
2
Private Organizations
Primary Care Unit
Foundation
2
1
1
2
1
1
TOTAL
34
Table 1: Portuguese health centers with ongoing with more than 4 Interventional clinical trials
77
This survey was designed to collect and to identify the strengths and needs of each Portuguese health
unit. The questionnaire was sent by email with a cover letter to each target contact. In addition PtCRIN
provided a website link to the on-line questionnaire.
The questionnaire was composed by 2 different sections:
· Overall description of Clinical research in the Country
· Assessing existing capacities and current practices in national health units centers with Interventional
and non- interventional clinical trials
Data analyses included:
· General analysis, i.e., comprehensive overview of clinical research types conducted in Portugal;
· INFARMED data regarding the interventional clinical trials;
· Health units data regarding personnel involved, Experience in clinical research, number of ongoing
clinical trials, services already offered by each Clinical Research Centre (CRC).
1
Source: Data available from the Medicinal Products Authority (INFARMED)
In Portugal, many individual public hospitals are part of hospital centers which include several neighboring
hospitals. This explains why the number of individual’s hospitals is larger than that of centers.
2
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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III.
GLOBAL OVERVIEW
The first step of our survey was achieved with the help of the “Assessing the existing capacities and
current practices” questionnaire, 34 Health centers/Institutions were contacted which represents 77
Portuguese individual health units. The deadline to submit the response was the 31st of September.
PtCRIN received answers from 14 Health centers/institutions which represents 34 individual health
centers. See table 2. This questionnaire was the first questionnaire for the network and the response
rate was 44%. Importantly, those who did answer are the Health institutions with more experience
and ongoing clinical trials. The response rate can also be explained by PtCRIN being relatively unknown
when the questionnaire was initially sent to the Health Administration Boards.
Health centers that received and completed the survey:
PORTUGUESE CENTERS
CENTRO HOSPITALAR E UNIVERSITARIO DE COIMBRA (CHUC)
CENTRO HOSPITALAR DE LISBOA NORTE (CHLN)
HOSPITAL DE SÃO JOÃO (HSJ)
CENTRO HOSPITALAR DE LISBOA CENTRAL (CHLC)
INSTITUTO PORTUGUÊS DE ONCOLOGIA DE PORTO FRANCISCO GENTIL (IPOPFG)
CENTRO HOSPITALAR DE LISBOA OCIDENTAL (CHLO)
INSTITUTO PORTUGUÊS DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL (IPOLFG)
HOSPITAL PROFESSOR DOUTOR FERNANDO FONSECA (HFF)
CENTRO HOSPITALAR DO PORTO (CHP)
ASSOCIAÇÃO PARA A INVESTIGAÇÃO BIOMÉDICA E INOVAÇÃO EM LUZ E IMAGEM (AIBILI)
CENTRO HOSPITALAR DO BAIXO VOUGA
INSTITUTO PORTUGUES DE ONCOLOGIA DE COIMBRA FRANCISCO GENTIL (IPOCFG)
CENTRO HOSPITALAR DE VILA NOVA DE GAIA/ESPINHO
CENTRO HOSPITALAR DE TRÁS-OS MONTES E ALTO DOURO
HOSPITAL DA LUZ, SA
HOSPITAL DE FARO
HOSPITAL BRAGA
HOSPITAL DO ESPÍRITO SANTO ÉVORA
CENTRO HOSPITALAR ENTRE DOURO E VOUGA
CENTRO HOSPITALAR DE SETÚBAL
CENTRO HOSPITALAR BARREIRO MONTIJO
ASSOCIAÇÃO PROTECTORA DOS DIABÉTICOS DE PORTUGAL (APDP)
CENTRO HOSPITALAR DE LEIRIA/ POMBAL
CENTRO HOSPITALAR TONDELA/ VISEU
UNIVERSIDADE DO MINHO & CENTRO CLINICO ACADÉMICO DE BRAGA
HOSPITAL DISTRITAL DE SANTARÉM EPE
INSTITUTO DE OFTALMOLOGIA DR. GAMA PINTO
HOSPITAL PÚBLICO PRIVADO DE CASCAIS DR. JOSÉ DE ALMEIDA
HOSPITAL DISTRITAL DA FIGUEIRA DA FOZ, EPE
HOSPITAL DIVINO ESPÍRITO SANTO DE PONTA DELGADA EPE
CENTRO HOSPITALAR DA COVA DA BEIRA
4
FUNDAÇÃO CHAMPALIMAUD
3
UNIVERSIDADE DE AVEIRO - SECÇÃO AUTÓNOMA DE CIÊNCIA DA SAÚDE
3
CENTRO DE SAUDE DE OEIRAS
Ongoing Interventional
3
Clinical Trials
158
135
98
96
61
61
48
46
43
25
24
20
14
13
13
12
12
12
11
10
9
8
8
7
6
5
5
5
4
4
4
0
0
0
Table 2: Centers that completed the survey highlighted in green.
The most productive institutions regarding clinical research were amidst the 44% response rate. For
example nine out of the 10 most productive institutions answered the questionnaire.
Additional documentation: Annex 1 includes the questionnaire sent to the institutions/centres.
3
Source: Data available from the Medicinal Products Authority (INFARMED).
4
Centers without clinical trials ongoing but with interest in PtCRIN activities.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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IV. RESULTS
Description and Definition of the clinical research (CR) conducted in the country.
1. INTERVENTIONAL CLINICAL RESEARCH5
1.1. Types of Medicinal Product
Biological / biotechnological origin
76
Chemical origin
42
Another type of medicinal product
13
Immunological medicinal product
(such as vaccine, allergen, immune serum)
Other extractive medical product
3
Plasma derived medical product
1
Cell therapy medicinal product
0
Gene therapy medicinal product
0
Radiopharmaceutical medicinal product
0
Medicinal product containing genetically modified organisms
0
2
Table 3: Types of Medicinal Product submitted to INFARMED (2012).
1.2. Clinical Trial Development Phase
Chart 1: Total number of applications and Clinical Development Phase submitted to INFARMED (2012).
5
Source: Data available from the Medicinal Products Authority (INFARMED), 2012
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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1.3. Type of Clinical Trial
Safety
114
Efficacy
110
Pharmacokinetics
64
Treatment
59
Pharmacogenomics
38
Pharmacodynamics
29
Pharmacogenetics
22
Pharmacoeconomics
17
Dose - Response
15
Prophylaxis
4
Diagnostic
1
Bioequivalence
1
Medical devices
(with IMP that is a combination product with a device)
Advanced therapies
(cells/tissues not considered medicinal products)
Organ transplants
2
Data not available
Data not available
Table 4: Type of clinical trial submitted to INFARMED (2012).
1.4. Therapeutic Areas
Chart 2: Total number per Therapeutics areas submitted to INFARMED (2012).
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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2.
NON-INTERVENTIONAL CLINICAL RESEARCH 6
2.1. Type of therapy
12
11
10
10
8
8
6
4
4
4
3
2
2
1
1
1
1
0
CHP; AIBILI; Hospital da Luz; IPOPFG; SACS-UA; IPOLFG; CHLO; CHLN; CHLC; CHUC; CCAB-UM
CHP; AIBILI; Hospital da Luz; IPOPFG; IPOLFG; Inst. Oftalm. Dr. Gama Pinto; CHLO; CHLN; CHLC; CCAB-UM
CHP; AIBILI; Hospital da Luz; IPOPFG; CHCB; CHLO; CHLC; CCAB-UM
IPOLFG; IPOPFG; CHLN
CHP; IPOPFG; CHLN; CHLO; CHLC
AIBILI
CHLO; CHLC; CHUC; HFF Med.IV
CHUC
SACS -UA
SACS-UA; IPOPFG
CHLC
Chart 3: Non-Interventional clinical research type of therapy per centers. Data provided by the centers.
3 items are the principal type of therapy by a minimum of 50% of the responders: Medicinal Products,
Medical Devices and surgery which reflects the type of clinical study performed in Portugal.
6
Data provided by the centers.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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2.2. Therapeutic Areas (non-interventional)
9
9
8
8
7
4
3
4
3
2
1
1
1
CHP; AIBILI; SACS-UA; CHCB; CHLO; CHLC; CHUC; CCAB-UM; HFF-Medicina IV
CHP; AIBILI; H. LUZ; CHLO; CHLC; CHUC; CCAB-UM; HFF-Medicina IV
CHP; CHLO; CCAB-UM
CHP; AIBILI; SACS-UA; CHLO; CHLC; CHUC; HFF-Medicina IV
CHP; H. LUZ; IPO Porto; SACS-UA; IPO Lisboa; CHLO; CHLC; CHUC; CCAB-UM
CHP; CHLN; CHLC; CHUC
CHP; CHLO; CHLC
CHP; AIBILI; H. LUZ; IPO Porto; CHCB; CHLO; CHLC; CCAB-UM
CHLO;CHLC; CCAB-UM; HFF-Medicina IV
Inst. Oftalm. Dr. Gama Pinto; AIBILI
SACS-UA
CCAB-UM
HFF-Medicina IV
Chart 4: Main Therapeutic areas performed in the clinical Centers. Data provided by the centers.
2.3. Type of Clinical Study (non-interventional)

Incidence

Treatment

Prevalence

Prophylaxis

Safety

Effectiveness
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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3. NON-INTERVENTIONAL
AND
INTERVENTIONAL CLINICAL RESEARCH
3.1. Interventional Studies vs. Observational studies
300
Total nº of ongoing Observational studies:
250
Total nº of ongoing Interventional studies:
200
150
150
100
157
11
0
35
38
5
65
10
60
30
10
50
10
0
62
2
13
6
0
22
0
42
126
48
21
7
6
3
6
Chart 5: Total Number of ongoing Interventional Studies vs. Observational Studies. Data provided by the
centers.
3.2. International Trials and National Trials
Centers
Nº International
Trials
Nº National
Trials
CHP
35
0
AIBILI
37
11
Hospital da Luz
10
0
IPO Porto
69
7
SACS-UA
0
10
IPO Lisboa
62
0
Inst. Oftalm. Dr. Gama Pinto
13
2
CHCB
0
0
CHLO
32
11
CHLN
0
0
CHLC
33
13
CHUC
120
6
11
2
CCAB- UM
HFF-Medicina IV
Total
8
2
430
64
Table 5: Total number of national and international trials, including both interventional trials and
observational. Data provided by the centers.
Importantly, we know from INFARMED that there is only a handfull of national clinical trials, therefore
we can only assume that of the 64 ongoing national trials perhaps as most are observational studies.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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3.3. Status of the Sponsor
Chart 6: Status of the Sponsor. Data provided by INFARMED.
During the year of 2012 only 3 academic clinical trials were submitted to INFARMED.
3.4. Design of clinical trials
Chart 7: Total number of clinical trials design submitted to INFARMED (2012).
3.5. Sponsorship
Chart 8: Clinical trials Sponsorship submitted to INFARMED (2012).
Most questions point to the fact that the majority of funding is private, the public Sponsorship is
mainly from the national agencies (FCT, QREN) or European programs from EU-FP7.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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3.6. Years of Experience in Clinical Research
Years of experience in clinical research of the institution
CHUC
CHLN
AIBILI
IPO Lisboa
CCAB- UM
HFF-Medicina IV
SACS-UA
IPO Porto
CHLO
Inst. Oftalm. Dr. Gama Pinto
CHLC
Hospital da Luz
CHCB
CHP
0
5
10
15
20
25
30
35
Chart 9: Number of Years of Experience in Clinical Research.
3.7. Services already offered by each Clinical Research Institution
14
12
10
Numbers
of
centers
8
6
4
2
CHP; AIBILI; SACS-UA; IPO LISBOA;
CHLO; CHUC;CCAB-UM; HFF Med.IV
AIBILI; IPOPORTO; SACS-UA; IPO
LISBOA; CHLO; CHUC;CCAB-UM; HFF
Med.IV
AIBILI; IPOPORTO; SACS-UA; IPO
LISBOA; CHLO; CHLC; CHUC;CCAB-UM
CHP; AIBILI; SACS-UA; CHLO; CHUC
0
AIBILI; SACS-UA; IPO LISBOA; Inst.
Oftal. Gama Pinto; CHLO; CHUC
CHP; AIBILI; IPO PORTO; SACS-UA;
IPO LISBOA; Inst. Oftal. Gama Pinto;
CHLO; CHLN; CHLC; CHUC;CCAB-UM;
HFF Med.IV2
CHP; AIBILI; IPO PORTO; CHLO; CHUC
Chart 10: Services offered by each Clinical Research Centre
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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3.8. Number of Personnel Involved by center in clinical trials
Chart 11: Personnel Involved by center in clinical trials
The Portuguese clinical research centers which responded to the questionnaire are responsible for
701 ongoing clinical trials, if we compare with the total number of Physicians that is 736, this
represents one physician per clinical trial and 99% are working not exclusively.
The total number of pharmacists is 44, study nurses 149, project managers 131, CRA/ monitors 46,
the total number of statisticians 11 and data managers 19. This represents the importance of a
continued creation of high-value employment among the healthcare community and education.
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4. ORGANIZATION OF THE NATIONAL BODIES IN CHARGE OF CLINICAL RESEARCH
INFARMED – Under the aegis of the Ministry of Health the National Institute of Pharmacy and
Medicines (http://www.infarmed.pt/portal/page/portal/INFARMED/ENGLISH) is the National
Regulatory Authority that evaluates, authorises, regulates and controls human medicines as well as
health products namely medical devices, homeopathic products and cosmetics.
The Institute's main goal is to ensure the quality, safety and efficacy of medicines and the quality,
safety and performance of health products in order to avoid the risks of their use while ensuring
adequate standards of public health and consumer's protection.
CEIC - National Ethics Committee for Clinical Research, http://www.ceic.pt , Ethics Committee on the
clinical trial of medicinal products for human use, it is according to to the provisions in Law No.
46/2004 of 19 August, an independent body constituted by individuals linked to health and other
areas of activity, whose mission is to safeguard the rights, safety and welfare of participants in clinical
trials, by issuing an opinion on ethical research protocols that are submitted.
In order to fulfill this objective, the CEIC is the preliminary assessment and monitoring of all clinical
trials of medicines for human use.
CNPD – Comissão Nacional de Protecção de Dados – is the Portuguese Data Protection Authority.
The CNPD is an independent body, with powers of authority throughout national territory. It is
endowed with the power to supervise and monitor compliance with the laws and regulations in the
area of personal data protection, with strict respect for human rights and the fundamental freedoms
and guarantees enshrined in the Constitution and the law. http://www.cnpd.pt/english/index_en.htm
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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5. PRIVATE FUNDING OPPORTUNITIES FOR THE DEVELOPMENT OF CLINICAL TRIALS
There are a limited number of private foundations which do support clinical research. There is no
data about the level of donations specifically for clinical research but it is certainly well below that of
government funding for academia. The pharmaceutical industry also supports research mainly
through their association, awards from individual companies, or collaboration with patient
associations. In general these are not large grants (< 50.000€) and the industry sponsors mainly
hospitals rather than academia. Some examples:
 Fundação Calouste Gulbenkian
 Fundação Champalimaud
 Prémio Pulsar em Investigação: Hospital Pedro Hispano
 Prémios Pfizer de Investigação Clínica e Investigação Básica
 Prémio SCML/MSD em Epidemiologia Clínica
 Bolsa de Investigação APMGF/AstraZeneca – Cuidados de Saúde Primários
 Bolsa Jovens Especialistas de Pneumologia SPP-AstraZeneca

Bolsa de Investigação Fundação AstraZeneca / Faculdade de Medicina da Universidade de Lisboa
 Bolsa De Estudo Pedro Eurico Lisboa - SPD/BAYER
 Prémio Hargreaves - SPD/JABA
 Bolsa Dr. M.M Almeida Ruas - SPD/NOVO NORDISK
 Prémio Sanofi-Aventis - SPD/SANOFI-AVENTIS
 Prémio De Investigação Clínica Na Diabetes Nuno Castel-Branco - SPD/LILLY Portugal
 Prémio Melhor Artigo Científico: Investigação Clínica FMUC - GAI
 Prémios, Bolsas de Estudos e Menções Honrosas da Liga Portuguesa Contra a Epilepsia
 Prémio Professor Alexandre Moreira – Investigação em Medicina Sexual
 Grande Prémio BIAL de Medicina
 Prémio BIAL de Medicina Clínica
 Merck Sharp and Dohme (MSD): Prémio do NEDVC “AVC e Investigação Clínica
 Prémio NEDAI | de Investigação Clínica em Auto-Imunidade 2012
 Bolsa D. Manuel de Mello - José de Mello Saúde
 Prémio Janssen Neurociências
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6. PUBLIC FUNDING OPPORTUNITIES FOR THE DEVELOPMENT OF CLINICAL TRIALS 7
The Fundação para a Ciência e a Tecnologia (FCT) consists in continuously promoting the
advancement of scientific and technological knowledge in Portugal, exploring opportunities that
become available in any scientific or technological domain to attain the highest international
standards in the creation of knowledge, and to stimulate their diffusion and contribution to improve
education, health, environment, and the quality of life and well being of the general public.
This mission is mainly accomplished through the funding, subsequent to the evaluation of the merit,
of proposals presented by institutions, research teams or individuals in public open calls, and also
through cooperation agreements and other forms of support in partnership with universities and
other public or private institutions, in Portugal and abroad. FCT annual budget is around 400 million
euros.
FCT supports several science and technology prizes. The available information includes:

Fernando Gil International Prize

L’Oréal Portugal Medals of Honor for Women in Science

FCT Santander Universities Research Prize for young Lecturers and Researchers

Prize for scientific or technical translation into the Portuguese language FCT / União Latina

Pulido Valente Prize

Maria Cândida da Cunha Prize

Harvard-Medical School-Portugal Program
Other research public funding opportunities:
Innovation Agency

Projectos de I&D em Co-promoção

Projectos Mobilizadores

Qualificação de Recursos Humanos

I&D internacional
7
Funding through calls not restricted to clinical research
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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7. STRUCTURE OF THE NATIONAL NETWORK PtCRIN
PtCRIN is not yet an independent formal organization and is being hosted by Nova Medical School and
Portuguese Society of Pharmacology. PtCRIN (http://web.fcm.unl.pt/ptcrin/) is funded through an
ECRIN/FP7 project (ECRIN –IA, INFRA – 2011.1.1.5), by Nova Medical School for building, personnel,
equipment, consumable and administrative as an infrastructure by Nova Medical School.
Investigators from several hospitals and medical schools participate through representatives.
The coordination structure of the network is linked with this temporary management structure. The
ECRIN Network Committee Member and PtCRIN National Representative coordinate these efforts
while the final flowchart of PtCRIN is not properly established.
The organization responsibilities include the seamless integration of PtCRIN in ECRIN and its
networks. The integration will take advantage of central ECRIN training programs, access to SOP
(standard operating procedures) developed within ECRIN, consultants in study design, participation in
academic clinical trials sponsored by the ECRIN partners, and combined recruitment.
With the establishment of PtCRIN as a consortium, during the 2013 year, the network is expected to
be efficient, achieve significant visibility and attract academic clinical trials sponsored by European
partners.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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7.1. Centers of the National Network
The survey was sent to all Portuguese health units with Ongoing Interventional clinical trials8 as
described in the Methodology section, but not all are PtCRIN subscribers although most of members
include representatives from 9 out of the 10 most productive centers in Portugal regarding output of
commercial clinical trials.
Ongoing
Interventiona
PORTUGUESE CENTERS
l clinical
trials
CENTRO HOSPITALAR E UNIVERSITARIO DE COIMBRA, (CHUC)
158
CENTRO HOSPITALAR DE LISBOA NORTE (CHLN)
135
HOSPITAL DE SÃO JOÃO (HSJ)
98
CENTRO HOSPITALAR DE LISBOA CENTRAL (CHLC)
96
INSTITUTO PORTUGUÊS DE ONCOLOGIA DE PORTO FRANCISCO GENTIL (IPOPFG)
61
CENTRO HOSPITALAR DE LISBOA OCIDENTAL (CHLO)
61
INSTITUTO PORTUGUÊS DE ONCOLOGIA DE LISBOA, FRANCISCO GENTIL (IPOLFG)
48
HOSPITAL PROFESSOR DOUTOR FERNANDO FONSECA (HFF) - Serviço Medicina IV
46
CENTRO HOSPITALAR DO PORTO (CHP)
43
ASSOCIAÇÃO PARA A INVESTIGAÇÃO BIOMÉDICA E INOVAÇÃO EM LUZ E IMAGEM (AIBILI)
25
CENTRO HOSPITALAR DO BAIXO VOUGA
24
INSTITUTO PORTUGUES DE ONCOLOGIA DE COIMBRA FRANCISCO GENTIL (IPOCFG)
20
CENTRO HOSPITALAR DE VILA NOVA DE GAIA/ESPINHO
14
HOSPITAL CURRY CABRAL, EPE
13
CENTRO HOSPITALAR DE TRÁS-OS MONTES E ALTO DOURO, EPE
13
HOSPITAL DA LUZ, SA
13
HOSPITAL DE FARO
12
HOSPITAL BRAGA
12
HOSPITAL DO ESPÍRITO SANTO ÉVORA
12
CENTRO HOSPITALAR ENTRE DOURO E VOUGA
11
CENTRO HOSPITALAR DE SETÚBAL
10
CENTRO HOSPITALAR BARREIRO MONTIJO
9
ASSOCIAÇÃO PROTECTORA DOS DIABÉTICOS DE PORTUGAL (APDP)
8
CNTRO HOSPITALAR DE LEIRIA/ POMBAL
8
CENTRO HOSPITALAR TONDELA/ VISEU
7
UNIVERSIDADE DO MINHO & CENTRO CLINICO ACADÉMICO DE BRAGA
6
HOSPITAL DISTRITAL DE SANTARÉM EPE
5
INSTITUTO DE OFTALMOLOGIA DR. GAMA PINTO
5
HOSPITAL PÚBLICO PRIVADO DE CASCAIS DR. JOSÉ DE ALMEIDA
5
HOSPITAL DISTRITAL DA FIGUEIRA DA FOZ, EPE
4
HOSPITAL DIVINO ESPÍRITO SANTO DE PONTA DELGADA EPE
4
CENTRO HOSPITALAR DA COVA DA BEIRA
4
FUNDAÇÃO CHAMPALIMAUD
1
UNIVERSIDADE DE AVEIRO - SECÇÃO AUTÓNOMA DE CIÊNCIA DA SAÚDE
0
CENTRO DE SAUDE DE OEIRAS
0
PtCRIN
Subscriber
Represented
Represented
Represented
Represented
Represented
Represented
Represented
Represented
Represented
Represented
Represented
Table 6: Portuguese Clinical Research Infrastructures Network Subscribers
PtCRIN members include representatives from 9 out of the 10 most productive centers in Portugal
regarding output of commercial clinical trials.
8
Source: Data available from the Medicinal Products Authority (INFARMED)
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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V. CONCLUSION
The survey “Assessing the Portuguese Clinical Research existing capacities and current practices” was
accomplished and sent to ECRIN to be included in the European survey.
Regarding clinical trials with human medicines, the main source of data was INFARMED. PtCRIN now
knows that most trials in Portugal are with biologics. Also, the majority of them are Phase III, with
phase I trials being negligible. Their cover all types of objectives from pharmacokinetics to efficacy.
The leading therapeutic areas are cancer and rare diseases; pediatrics, neuroscience and
cardiovascular areas are also common. The majority of trials are international and privately funded.
National and publically funded interventional trials in Portugal are inexistent.
Regarding, non-interventional or observational studies, the main source of data was the centers
themselves. The main findings of the questionnaire are that type of therapy is with medicinal
products, medical devices and surgical interventions. There are some therapy niches which could be
explored further: advanced therapies, nursing, and validation of research tools. As for the therapeutic
areas, the most common are cancer, cardiovascular and neuroscience. Other areas that are being
covered are ophthalmology, aging, AIDS, and nutrition.
When the productivity of centers in both these types of studies is compared it is notice worthy that in
general the stronger one institution is in clinical trials, the stronger it also is in observational trials.
Data collected from the centers regarding the services were surprising more specific tools are needed
to ensure the quality of data.
When it comes to human resources in clinical research, one very important finding is that personnel
involved in clinical research is part time. The other is that the ratio of physicians to other support
personnel of clinical trials (research nurses, pharmacists, project managers, statisticians, data
managers, monitors) is very high, that is 736 physicians to 400 other professionals. This indicates that
physicians do not seem to be able to count on strong multidisciplinary teams to support them in
conducting clinical research. Also, the ratio of physician per trial is about 1 (736 physicians to 701
ongoing trials).
The scenario revealed above shows that there is much to be done in Portugal regarding productivity
and resources. The participation in PtCRIN of the more active centers doing clinical research will allow
a more specific identification of needs and constrains to be surpassed.
Report on results from the survey Assessing the Portuguese Clinical Research existing capacities and current practices.
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