Barriers for Clinical Research in Latin America

Jorge Gomez, M.D., Ph.D.Office of Latin American Cancer Program

DevelopmentNational Cancer Institute (NCI)

National Institutes of Health (NIH)

U. S. National Cancer Institute (NCI)

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.

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

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

Uruguay

Chile

Argentina

US-LACRN

About Latin American Cancer Research NetworkMost technologically advanced countries in Latin AmericaNational program developed for cancer prevention, control, detection, and treatmentDeveloped training programs in-country and in other countriesResearch collaborations with other Latin American countriesCancer epidemiology and morbidity resembles the trends observed in Latin American countries

Infrastructure supporting cancer researchPublic Healthcare system Academic institutions/trained professionalsClinical research collaborations and facilitiesTelecommunicationsBioinformatics (systems and software applications)

United States-Latin America Cancer Research Network (US-LA CRN)

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.

Argentina Brazil Chile Mexico Uruguay United States

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

NCI/FIC Resources

GrantsContracts

Knowledge TransferTraining

NCI/FIC Resources

GrantsContracts

Knowledge TransferTraining

Public-Private PartnershipsIndustryProfessional SocietiesAdvocacy Organizations

Public-Private PartnershipsIndustryProfessional SocietiesAdvocacy Organizations

Latin AmericanPartners

Goverments Academia

Latin AmericanPartners

Goverments Academia

Contributions(US/Foreign)Philanthropic and In-kind servicesFoundations

Contributions(US/Foreign)Philanthropic and In-kind servicesFoundations

US-LA CRN

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)

Benefits for Latin American Countries

Advancing cancer research and establishing sustainable infrastructure1. Basic & Clinical Research2. Training3. 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 CollinsFIC’s Global Health Matters Newsletter

NIH “Town Meeting”August 17, 2009