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Barriers for Clinical Research in
Latin America
Jorge Gomez, M.D., Ph.D.
Office of Latin American Cancer Program
Development
National Cancer Institute (NCI)
National Institutes of Health (NIH)
U. S. National Cancer Institute (NCI)
The Department of Health and Human Services is the principal agency for
protecting the health of all Americans. It is comprised of the Office of the
Secretary and 11 Operating Divisions.
The NIH provides leadership and direction to programs designed to improve
the health of the United States by conducting and supporting research
The National Cancer Institute (NCI) conducts and supports research,
training, health information dissemination, and other programs with
respect to the cause, diagnosis, prevention, and treatment of cancer,
rehabilitation from cancer, and the continuing care of cancer patients and
the families of cancer patients in the US and globally.
Office of Latin American Cancer Program
Development (OLACPD)
Vision
• To advance local and global initiatives to prevent,
diagnose, and treat cancer by facilitating the
development of a comprehensive cancer research
infrastructure in Latin America
Mission
• To advance the mission of NCI by collaborating
with government agencies, researchers, and
organizations to further cancer research in Latin
American countries
Significance of Cancer Research for
Public Health in US and Latin America
The decrease of deaths from infectious disease, urbanization and lifestyle
trends, and the aging of the global population has attributed to increased
cancer deaths worldwide
Cancer has caused more deaths worldwide than AIDS, tuberculosis, and
malaria combined (Source: WHO) and is currently ranked among the top three
killers in Latin America
Cancer deaths and co-morbidities create additional burdens to healthcare
systems
Collaborations in cancer research can provide a foundation for future
development of evidence-based cancer detection, therapeutic and prevention
strategies, and technologies
United States-Latin America Cancer
Research Network (US-LA CRN)
Bi-lateral agreements (LOI)
through governments
launched a new concept for
global partnership. Each
country established their
respective network of
institutions and
investigators to conduct
cancer research.
United States
Mexico
Brazil
Chile
Uruguay
Argentina
US-LACRN
About Latin American Cancer Research Network
Most technologically advanced countries in Latin America
National program developed for cancer prevention, control, detection, and treatment
Developed training programs in-country and in other countries
Research collaborations with other Latin American countries
Cancer epidemiology and morbidity resembles the trends observed in Latin American countries
Infrastructure supporting cancer research
Public Healthcare system
Academic institutions/trained professionals
Clinical research collaborations and facilities
Telecommunications
Bioinformatics (systems and software applications)
United States-Latin America Cancer
Research Network (US-LA CRN)
Argentina Brazil Chile Mexico Uruguay United States
BREAST CANCER
First collaborative project of the US-LA CRN
The cancer research networks from each country cooperatively engaged in
the development of the clinical protocol; standardization of
clinical/oncology procedures, pathology procedures, molecular biology
procedures; development of epidemiologic questionnaire; testing and
training of the bioinformatics tools; and, development of QC and QA
checkpoints.
MOLECULAR PROFILING OF STAGE II AND III BREAST CANCER IN LATIN
AMERICAN WOMEN RECEIVING STANDARD OF CARE TREATMENT
The primary objective is to characterize the distribution of invasive breast cancer stage II
or III molecular profiles (luminal type A, luminal type B, human epidermal growth factor
receptor 2 (HER2)-like, basal) in Latin American women.
Secondary Objectives
To find an association between molecular profiles and histopathologic characteristics of the tumor
prior to treatment, including histological type, size, lymph node involvement, and surrogate
markers.
To estimate the rate of pathologic complete response (pCR) to standard neoadjuvant chemotherapy
in each of the breast cancer molecular subtypes and to evaluate any differences in success rates
among the molecular subtype cohorts. In addition, a more complex and detailed pathologic
evaluation called residual cancer burden (RCB) will be used to evaluate partial pathologic
response to therapy.
To discover and develop predictive and prognostic gene expression signatures.
To determine three- and five-year overall survival (OS), time to first failure (TFF) and disease-free
survival (DFS) for each molecular subtype and to evaluate any differences in those parameters
among the subtype cohorts.
To document the demographic and epidemiologic characteristics of each molecular subtype
NCI-INCA Building Partnerships for Latin
America
Building strategic partnerships
that can lead the way to forming
concrete and effective alliances
with:
Other governments (Ministry of
Health, Ministry of Science &
Technology)
International Organizations ( PAHO
and WHO)
NGOs (Susan G. Komen Foundation
for the Cure )
Professional Societies (ASCO,
FLASCA, AMEH)
NCI/FIC
Resources
Grants
Contracts
Knowledge Transfer
Training
Public-Private
Partnerships
Industry
Professional Societies
Advocacy Organizations
US-LA CRN
Latin American
Partners
Goverments
Academia
Contributions
(US/Foreign)
Philanthropic and
In-kind services
Foundations
Benefits for Latin American Countries
 Advancing cancer research and establishing sustainable infrastructure
1.
2.
3.
Basic & Clinical Research
Training
Advanced Technologies and Capacity Building
Focusing on 21st century biomedical concepts
Impact on pubic health on national and regional level
Improving biobanking process in Latin America
Enhancing existing cancer research networks
Heighten public awareness on the significance of collaborative cancer
research for reducing cancer morbidity
GLOBAL HEALTH AS AN NIH PRIORITY
“Global health research ‘should be a
conversation with other countries,’
but not one in which the great
‘United States tells the world what
the answers are without listening to
their experiences’."
Remarks of NIH Director Francis Collins
FIC’s Global Health Matters Newsletter
NIH “Town Meeting”
August 17, 2009