Academic Research in LA

Academic Research in LA Dr. Carlos H. Barrios Faculdade de Medicina, PUCRS Instituto do Câncer, HMD LACOG, Latin American Cooperative Oncology Group Porto Alegre, Brasil

36% improvement

Age-Adjusted Male Mortality Siegel R, et al. CA Cancer J Clin 2011;61:212-236. VC 2011 American Cancer Society.

Age-Adjusted Female Mortality Siegel R, et al. CA Cancer J Clin 2011;61:212-236. VC 2011 American Cancer Society.

Age adujsted mortality rates, women. Brazil (1979-2004) Source, INCA, MS, Brazil

Number of Studies www.clinicaltrials.gov (N=160.326) ClinicalTrials.gov currently lists 160.326 studies in 181 countries Researched on Feb 2 nd 2014. www.clinicaltrials.gov

Number of Studies www.clinicaltrials.gov (N=160.326) ClinicalTrials.gov currently lists 160.326 studies in 181 countries Non-US Only (45%) US Only (40%) Not Specified* (9%) Both US/Non-US (6%) Total 160,326 Researched on Feb 2 nd 2014. www.clinicaltrials.gov

Clinical Research in South America - 2014 World 160.326 South America 5474 (3.4%) Argentina 1689 Bolivia 24 Brazil 3708 (2.3%) Chile 904 Colombia 724 Ecuador 84 Guyana 1 Paraguay 15 Peru 688 Suriname 1 Uruguay 48 Venezuela 137 www.clinicaltrials.gov, (Feb, 2014)

Number of Studies in Cancer www.clinicaltrials.gov (N=41.757) Researched on Feb 2 nd 2014. www.clinicaltrials.gov

Clinical Cancer Research in South America - 2014 World 41.757 South America 1.030 (2.4%) Argentina 452 Brazil 711 (1.7%) Chile 213 Colombia 146 Ecuador 19 Peru 231 Uruguay 20 Venezuela 38 www.clinicaltrials.gov, (Feb, 2014)

Clinical Cancer Research Europe - 2014 World 41.757 www.clinicaltrials.gov, (Feb, 2014)

Early vs. Late Phase Trials in Emerging Regions Asia 102 6% Latin America 22 4% 35 6% 540 32% 435 26% 181 31% 52 3% 562 33% 26 6% 61 14% 329 56% 16 3% 11 2 6% 1% 41 22% 199 44% 18 4% 145 32% Middle East 127 68% 6 3% Africa clinicaltrials.gov

CLINICAL RESEARCH REGULATORY TIMELINES ACROSS THE WORLD 5-12 months CANADA 3-4 months 5 months REINO UNIDO SUÉCIA 3 months 4-5 month s UNITES STATES 3 months FRANÇA 12 months MÉXICO 3 4 months COLOMBIA PERU 4 5 months BRAZIL 10-14 months 3 months 4 months AUSTRÁLIA CHILE ARGENTINA 4 4,5 months 9 months 4 months Adapted from: Hurley D. GCP Journal March 2006. 41st Annual Drug Information Association Meeting, 2005.

REGULATORY AGENCIES APPROVAL TIMES in the ALTTO trial (BIG02-06) Average* 58d 26d 60d 171d TIME TO APPROVAL IN DAYS P=.046 P=.21 P=.05 In this study the regulatory agencies in South America required many more days to approve the protocol in comparison to remaining regions EUROPE NORTH AMERICA ASIA-PACIFIC SOUTH AMERICA AFRICA PARTICIPATING COUNTRIES ANOVA F = 3.39, P = 0.031

Nature, Vol 450, November 29 th, 2007

Nature, Vol 450, November 29 th, 2007 US$28 billion investment in S&T 1.5% of GDP (increase of 50%)

US$28 billion investment in S&T 1.5% of GDP (increase of 50%) Lack of technological innovation in the private industry. Most researchers in the public sector. Nature, Vol 450, November 29 th, 2007

US$28 billion investment in S&T 1.5% of GDP (increase of 50%) Lack of technological innovation in the private industry. Most researchers in the public sector. 2% of scientific publications Ranking 15 th in the world Nature, Vol 450, November 29 th, 2007

US$28 billion investment in S&T 1.5% of GDP (increase of 50%) Lack of technological innovation in the private industry. Most researchers in the public sector. 2% of scientific publications Ranking 15 th in the world 0.1% of global registered patents Nature, Vol 450, November 29 th, 2007

Nature, Vol 450, November 29 th, 2007

Brazil Research and Development Expenditure (% of GDP) Brazil 2010: 1.1% http://www.worldbank.org/br Nature, Vol 450, November 29 th, 2007

In 2011, R&D expenditure was 0 65% of GDP, which is many times less than in developed countries

Saturation of Clinical Trial Sites Region Number of Trial Sites (per 1M Population) US 82 Western Europe 11 Central / Eastern Europe 8 Latin America 2 Asia Pacific < 1 Source: Raps Focus, 2009, Latin American CTAs

Private Participation in R&D is Relatively Low in LA (% of R&D financed by the private sector) Sources: RICYT (Red de Indicadores de Ciencias y Tecnologia, 2007 OEDC Data, 2008

Where are the Researchers? Private Sector Government University Brazil, Ministry of Science and Technology Main Science and Technology Indicators OECD, 2007

Industry-University Collaboration in LA (relatively low as compared with other countries) Weighted Average: Rating is from 1-7 (7 means highest collaboration) World Economic Forum: Global Competitiveness Report 2010-2011.

Comparative Patenting by LA Countries (Cumulative 2004-2009) US Patent Office Data, 2004-2009

Scientific Publications by Researchers from Brazilian Institutions (1992-2008) Thomson Reuters (Scientific) Inc. Web of Science (Science Citation Index Expanded), May 2010.

Brazilian Science in Latin America Source: Thomson Reuters. National Science IndicatorsBrazilian Ministry of Science and Technology, 18 Sep 2007. http://www.mct.gov.br/index.php/content/view/9257.html Source: Thomson Reuters. National Science Indicators Brazilian Ministry of Science and Technology, 18 Sep 2007. http://www.mct.gov.br/index.php/content/view/9257.html

The Geography of Clinical Cancer Research. Analysis of ASCO Abstracts Saad ED, et al. Annals of Oncology 21:627, 2010

The Geography of Clinical Cancer Research. Analysis of ASCO Abstracts There was a statistically significant temporal trend in the proportion of multinational studies. Multinational studies and abstracts with United States nationality were more frequently presented in oral and poster fashion and had more frequent involvement of the pharmaceutical industry. Saad ED, et al. Annals of Oncology 21:627, 2010

Clinical Research in LA: Challenges Regulatory Processes; Bureaucracy. Lack of Investment (Public and Private). Sponsor is responsible for 100% of costs (need to cover standard procedures). Post-study medication provision. Restrictions in sending biological material across borders for genetic testing. Human Resources: Training and support of young talents. Public Education (general population) with regard to Clinical Research. Need to develop and support a Culture of Cooperation.

Potential of Accrual 173 70 members 57 sites 12 countries 164 145 138 133 111 108 LACOG Institutions Number of new cases per month = 7001 105 96 80 58 58 1265 Breast Prostate Colorrectal: Lung Skin Stomach Cervix Head and Neck Uterus 204 LNH Sarcoma Melanoma Larynx 210 697 Brain Thyroid 213 Kidney Esophagus 306 514 Pancreas Leukemia 307 379 497 Hepatic LH Mieloma