academic research in europearchives.innovationinbreastcancer.com/files... · type 1: designed and...
TRANSCRIPT
Academic Research in Europe
Dra. Eva Carrasco
Scientific DirectorSpanish Breast Cancer Research Group
Type of clinical trials
Type 1:Designed and
sponsored by the Pharmaceutical
Industry, proposed to the Investigator and
accepted
Type 2:Designed and
sponsored by the Investigator, proposed to the Pharmaceutical Industry and accepted
Type 3:Designed and sponsored by the Investigator, not
supported by the Pharmaceutical Industry
Investigator sponsored clinical trials
Type 1:Designed and
sponsored by the Pharmaceutical
Industry, proposed to the Investigator and
accepted
Type 2:Designed and
sponsored by the Investigator, proposed to the Pharmaceutical Industry and accepted
Type 3:Designed and sponsored by the Investigator, not
supported by the Pharmaceutical Industry
Truly non commercialAcademic Trials
Is the academic research necessary?
Is the academic research necessary?
EORTC (2001)
“The 40% of the studies that have changed the management of
Cancer in the last 40 years have been sponsored by the Academy”
Is the academic research necessary?
YES!: there is a need to respond to “less” attractive questions for the pharmaceutical industry. “head to head” of already approved treatment options
Optimal duration of treatment
Studies needing a Long-term follow-up (adjuvant)
No drug-driven studies
Is the academic research necessary?
YES!: there is a need to respond to “less” attractive questions for the pharmaceutical industry. “head to head” of already approved treatment options
Optimal duration of treatment
Studies needing a Long-term follow-up (adjuvant)
No drug-driven studies
YES!: Need of high and quick recruitments of patients in clinical trials in cancer.
Is the academic research necessary?
Clinical trials
Clinical trials
Clinical trials
CT
Clinical trials
CT
Clinical trials
CT
Clinical trials
CT
Clinical trials
Before May 2004 After May 2004
Investigator clinical trial file
Academic clinical research issues
EU directive seems to be created thinking only on
registration of new compounds and
pharmaceutical industry research
Academic clinical research issues
Resources
Requirements
Academic clinical research issues
How to address these costs?
Public resources Charities Private sector (pharma industry)
How to address these costs?
0
100
200
300
400
500
600
700
800
Germany Denmark Spain France Italy The Netherland UK
Charities Public
4
1
2
64
413
1-61-1 2-2
Plus European funding: public_2007-2009 (265M€) and public-private_2007-2013 (2000M€)
Mill
ion
Eu
ros
(20
04
)
How to address these costs?
The role of funding and policies on innovation in cancer drug development. Panos Kanavos, Richard Sullivan, Grant Lewison, Willemien Schurer, Seth Eckhouse, Zefi Vlachopioti. European Cancer Research Managers Forum (ECRM). London School of Economics and Political Science, September 2009. Data of spending in R+D in oncology: Investment and Outputs of Cancer Research: from the Public Sector to Industry Public Industry. The Second Cancer Research Funding Survey. ECRM. European Cancer Research Managers Forum, Seth Eckhouse, Grant Lewison, Richard Sullivan, Septiembre 2007. Consulta de páginas webs en Octubre 2012: Webs pages:https://www.aecc.es/Paginas/PaginaPrincipal.aspx http://www.airc.it/ http://www.aicr.org.uk/ http://www.ailpescara.com/loginutenti.asp http://www.arc-cancer.net/ http://www.aphp.fr/ http://www.ayudas.net/Septimo_Programa_Marco_Investigacion_Desarrollo-11411BT1E2000R0P6O1PQ.html http://www.bmbf.de/en/ http://www.cancer.dk/om+os/The+Danish+Cancer+Society.html http://www.carreras-stiftung.de/ http://www.cnr.it/ http://www.cnrs.fr/ http://www.curie.fr/en http://dcs.kwfkankerbestrijding.nl/Pages/Home.aspx http://www.dfg.de/index.jsp http://www.en.fi.dk/councils-commissions/the-danish-council-for-independent-research/scientific-research-councils/medical-sciences http://www.fondazionefirc.it/ http://www.genomics.nl/ http://www.government.nl/ministries/vws http://www.inserm.fr/ http://www.isciii.es/ http://www.iss.it/chis/?lang=2 http://www.istruzione.it/web/hub/home https://www.krebshilfe.de/ http://www.legatumori.it/ http://www.ligue-cancer.net/ http://www.mineco.gob.es/portal/site/mineco/ http://www.obrasocial.lacaixa.es/ http://www.salute.gov.it/ http://www.wilhelm-sander-stiftung.de/cms/front_content.php http://www.zonmw.nl/en/
Indirect investment in oncology research: Health care systems Universities
Direct investment in oncology research: Basic/translational research
Drug development (clinical research)
Public funding
Data form 2006-2007. The role of funding and policies on innovation in cancer drug development. Panos Kanavos, Richard Sullivan, Grant Lewison, WillemienSchurer, Seth Eckhouse, Zefi Vlachopioti. 2009. European Cancer Research Managers Forum (ECRM). London School of Economics and Political Science, September 2009. Investment and Outputs of Cancer Research: from the Public Sector to IndustryPublic Industry. The Second Cancer Research Funding Survey. ECRM. European Cancer Research Managers Forum, Seth Eckhouse, Grant Lewison, Richard Sullivan, September 2007.
Public funding: direct investment
0
200
400
600
800
1000
1200
Germany Denmark Spain France Italy The Netherland UK
Título del gráficoBasic research Clinical research
426M€
1.100M€
389M€
233M€144M€
33M€77M€
56
2
64
9
18Investment per capita
High number of financing organizations with small investment
Higher investment in the UK, followed by Germany, France and Italy.
Cancer research is considered a priority in the UK and the Netherlands, not in other EU countries (though increasing).
Mainly through indirect sources (health care systems and Universities).
Direct investment:
Mainly dedicated to basic research
Clinical research focused on early phases
Public funding in Europe: summary
Fragmentation
Distribution vs public investment: Similar to public investment in the UK. Higher than public investment in countries like Denmark
and Sweden. Almost non existence in countries like Spain or Ireland.
Many small organizations focused on specific cancer types
Some big organizations with a general focus and huge investment in cancer research (Trust42 in the UK)
Charities
Through big Pharma
Contribution trend to be underestimated (lack of information provided by industry):
In 2004 3.1 B € in R&D in cancer worldwide.
Estimated to be a quarter of the total cancer research investment.
Private sector
Increasing worldwide and specifically in Europe.
Public-private collaboration
Big drug development centres in academic environments.
Example of the NCRI in the UK
65%
35%
2003
Internal R&D investment External R&D investment
55%
45%
2012
Spanish data: source BD metrics (14th edition)
Cooperative Groups: objectives
The main objective is to promote independent academic research in the field of Oncology applied to a particular tumor type or several types of cancer, in order to translate this research into practical applicability to patients.
Other objectives include the dissemination of the obtained results and knowledge, contributing to the scientific evidence.
Contribution to continuous medical education.
Cooperative Groups: advantages
Access to a broad, well-established network of highly qualified investigators and specialized hospitals and research centres.
Input from internationally renowned opinion leaders in cancer research.
Expertise in clinical trial design, conduct and analyses.
Scientific credibility by having the study conducted independently.
Money savings.
Cooperative Groups: different models
According to area of research: Multiple tumour types Focused on one tumour type
According to geography: Local (one country) International:
Direct membership of investigators Network (group of groups)
Local CG in all types of cancer
ICORG is a non-profit association officially registered in Ireland in 1996
ICORG is a collaboration of three parties – the Irish Clinical Oncology Research Group (ICORG) in Dublin, the Clinical Research Support Centre (CRSC) in Belfast, and oncology professionals
throughout Northern Ireland and the Republic of Ireland.
Mission and aims
Mission: To enable Irish patients to gain early access to new cancer treatments.
Aims: To promote, design, conduct and facilitate clinical cancer
research in the island of Ireland. Clinical cancer research means the investigation of methods
of prevention, diagnosis, management and treatment of patients with cancer.
Affiliated members
20Institutions
Group structure
Local CG in breast cancer
GEICAM is a non-profit association officially registered in Spain on April 4th, 1995
From June 2009 GEICAM is also a foundation registered in the Spanish Ministry of Education.
Mission
“Promote clinical, epidemiological and translational research as well as education and divulgation in Breast Cancer”
Affiliated members
Medical Oncologists(n=399)
Pathologists/biologistspGEICAM (n=86)
Surgeons/gynecologistsqGEICAM (n=123)
Radiologists/Nuclear Medicine
dGEICAM (n=39)
Radiation Oncologists/Physics
rGEICAM (n=74)
Epidemiologists/Prevention Medicine
epiGEICAM (n=5)
Other: 3
PharmacologistsfGEICAM (n=1)
Total: 730 members working in 181 institutions
General Assembly(399 voting members)
Steering Committee(20+5+working
groups coordinators+
Scientific Director)Renewal every
three years
Group structure
GEICAM Headquarter
Dr. Joan Albanell. Coordinator
Dr. Federico Rojo. Coordinator
Dr. Agustí Barnadas
Dr. Juan de la Haba
Dr. José E. Alés
Dr. José M. López Vega
Dra. Laura Estévez
Dr. Ángel Guerrero
Dr. José A. López Gª Asenjo
Dr. Manuel de las Heras
Dr. Miguel Martín. Strategic Advisor
Dr. Ramón Colomer
Dr. Ander Urruticoechea. Coordinator netGEICAM
Dr. Emilio Alba
Dr. José Palacios
Dr. Enrique de Aláva
Dra. Ana Lluch
Dr. Enrique de Lerma
Dr. Ignacio Aranda
TRANSGEICAM
renewable every three years
NEOADJUVANT
Dr Miguel A. Seguí. Coordinator
Dr. Miguel Gil
Dr. Lourdes Calvo
Dr. Pedro Sánchez Rovira
Dr. Ignacio Chacón
Dr. Melcior Sentís
Dr. Ignacio Tusquets
Dr. Manuel Ramos
Dr. Isabel Álvarez
Dr. Helena García
Dr. Marta Santiesteban
Dr. Julia Jiménez
Dr. Antonio Piñero
ADJUVANT
Dr. Álvaro Rodríguez-Lescure. Coordinator
Dr. Amparo Ruíz
Dr. Manuel Ruíz Borrego
Dr. César Rodríguez
Dr. Mireia Margelí
Dr. Sonia Servitja Torno
Dr. Amparo González Sanchís
Dr. Luis de la Cruz
Dr. Carlos Jara
EPIDEMIOLOGY / CHEMOPREVENTION
Dr. José M. Baena
Dr. Marina Pollán. Coordinator Epi
Dr. Miguel Martín
Dr. Ignacio Tusquets
Dr. Montserrat Muñoz
Dr. Laura Estévez
Dr. Pedro Sánchez Rovira
Dr. José E. Alés. Coordinator Chemo
Dr. Carlos Jara
Dr. Beatriz Pérez Gómez
Dr. Lola Salas
METASTATIC
Dr. Antonio Antón. Coordinator
Dr. Miguel Martín.
Dr. Montserrat Muñoz
Dr. Ricardo Sánchez Escribano
Dr. Isabel Blancas
Dr. Isabel Lorenzo
Dr. Julia Jiménez
Dr. Antonio Piñero
FAMGEICAM
Dr. Ivan Márquez Rodas. Coordinator
Dr. Gemma Llort Pursals
Dr. Ignacio Blanco
Dr. Sonia Servitja
Dr. Teresa Ramon y Cajal
Dr. Raquel Andres
Dr. Santiago Gonzalez
Dr. Ana Laura Ortega
Dr. Ana Casas
Dr. Antonio González Martín
Dr. Enrique Barrajón
Dr. Ander Urruticoechea
Dr. Ramón Colomer
Dr. Encarna Adrover
Dr. Joan Albanell. Coordinador
Dr. Federico Rojo. Coordinador
Dr. Agustí Barnadas
Dra. Ana Lluch
Dr. Emilio Alba
Dr. Juan de la Haba
Dr. José E. Alés
Dr. José M. López Vega
Dra. Laura Estévez
Dr. Ángel Guerrero
Dr. Miguel Martín. Asesor estratégico
Dr. Ander Urruticoechea (netGEICAM)
Dr. Ramón Colomer
Dr. Alberto Ocaña
Dra. Marta Santisteban
Dr. Manuel de las Heras
Dr. José Palacios
Dr. José A. López Gª Asenjo
Dr. Enrique de Aláva
Dr. Enrique de Lerma
Dr. Ignacio Aranda
TRANSGEICAM
Trials approval process working groups
International GC in all cancer types
The EORTC was founded as an international organization under Belgian law in 1962 by eminent oncologists working in the EU
countries and Switzerland.It was named GECA and became the EORTC in 1968.
300 Universities or Hospitals 2500
Physicians
6000 new patients a year
30 countries
Aims and mission
The aims of EORTC are:to develop, conduct, coordinate, and
stimulate translational and clinical research in Europe to improve the management of cancer
and related problems by increasing survival but also patient quality of life.
European Union:Belgium: 3France: 7Germany: 1The Netherlands: 5United Kingdom: 2Italy: 1
Non-EU countriesSwitzerland: 2
Affiliated members
The primary interests of the EORTC are clinical trials that investigate strategic therapeutic questions that will influence medical practice or will fundamentally
improve the understanding of a disease.
The EORTC Scientific Strategy encompasses the following types of clinical trials: Large phase III academic trials aimed to change the
standard of care Trials with a strong translational research component Trials addressing rare tumor types Trials optimizing integration of new agents in therapeutic
strategies.
Scientific strategy
Group structure
Brain tumours Breast cancer Children´s Leukaemia Gastrointestinal tract cancer Genito-urinary cancers Gynaecological cancer Head and neck cancer Imaging Infectious diseases
Leukaemia Lung cancer Melanoma Pathobiology Pharmacology and Molecular
mechanisms group Quality of Life Radiation oncology Soft tissue and bone sarcoma
Groups and task forces
Cancer in de elderlyCutaneous lymphoma
Endocrine tumours
Groups
Task forces
International network in breast cancer
Association founded by leading European opinion leaders in 1999. Network of 49 cooperative
groups in 50 countries31
EUROPE
1CANADA
6LATIN-
AMERICA
8ASIA
2AUSTRALIA
Mission
BIG facilitates and accelerates breast cancer research at the international
level by stimulating cooperation between its members and other
academic networks, and collaborating with, but
working independently from, the pharmaceutical industry.
General Assembly(49 voting members)
Executive board:9 members
Renewal every four years
Group structure
Trials development and conduct
The “Lead” Model. Trials led and run by the “BIG Network”. BIG HQ acting as coordinating data centre and providing statistical leadership (BrEAST Data Centre and Frontier Science Research and Technology Foundation). HERA and ALTTO.
The “Co-Lead” Model. Trials led and run by a BIG Group, with one or more other partners, and in which the BIG HQ is involved as a “Co-Lead”. NeoOLYMPIA.
The “Supporter” Model. Trials supported by the BIG umbrella, with a limited role for BIG HQ. PENELOPEB.
Thanks!