Barriers for Clinical Research in Latin America

1. 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)

2. 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.

3. 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

4. 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

5. 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

6. 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)

7. 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; developmentof epidemiologic questionnaire; testing and training of the bioinformatics tools; and, development of QC and QA checkpoints.

8. 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

9. 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 AdvocacyOrganizations US-LA CRN Latin American Partners Goverments Academia Contributions (US/Foreign) Philanthropic and In-kindservices Foundations

10. Benefits for Latin American Countries • Advancing cancer research and establishing sustainable infrastructure • 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

11. “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’." Global Health as an NIH Priority Remarks of NIH Director Francis CollinsFIC’s Global Health Matters Newsletter NIH “Town Meeting”August 17, 2009