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Clinical Trials Latin America Oct 2010 1

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  • 1. Latin America as an opportunity for Clinical Research
  • 2. Latin America 21 countries, Area: 21 069 501 km2 Population: 569 million people Heterogeneous population Two major official Languages: Spanish and Portuguese Average Life expectancy 75 years Population Concentrated in Major Urban Areas such as Mexico City, Sao Paulo or Buenos Aires Estimated population Growth 12.5% by 2015 Economic growth rate: 5.3% (2006) = per capita Increase 3.8% GDP: 3,3 Trillion exchange Rate Source: wikipaedia.com, www.paho.org and www.unep.net
  • 3. Latin America as a Pharma Market 7 Major Players: Argentina, Brazil, Chile, Colombia, Mexico, Peru and Venezuela 3 Top Markets: Argentina, Brazil and Mexico. 50 billion (2008) projected to 80 billion (2013) Different growth between countries: •Government cost containment policies •Economic Stability a concern Generics Drug Industry encouraged Health Care reforms for more people to access Medication Source: Julianne Lewis. International Regulatory Affairs. John Hopkins University
  • 4. Growth Rate of Clinical Research in Latin America Latin America Clinical Trial authorizations. Overview and Update. Regulatory Focus. June 2009. Denis Hurley, Mirta Lipezker and Daniel Mazzolenis.
  • 5. Southern Cone The 3 major countries in Latin America, with a total population of 300 million people are:  Brazil (192.09 million),  Argentina (40.48 million),  Chile (16.99 million). The region's ethnicity make up makes patient enrollment for any clinical study simpler.
  • 6. Why Latin America? Recruitment 1. Large, ethnically diverse population. 2. Availability of treatment-naive patients in all therapeutic areas. 3. Complementary to Northern hemisphere sites for indications with seasonal variations (such as respiratory diseases). 4. Strong patient-doctor relationship. 5. Good compliance & retention rates (minimal dropout rates). 6. Niche for emerging and neglected diseases. 7. Many significant metropolitan areas with population concentration in big cities:  Sao Paulo 19.88m in Brazil  Buenos Aires 13.35m in Argentina  Santiago 7.2m in Chile (www.worldpharmaceuticals.net/editorials/013_march08/013_latin.pdf; http://www.ghf06.org/reports/35) OUTSTANDING ENVIRONMENT FOR EXCELLENT RECRUITMENT PERFORMANCE
  • 7. Compared Recruitment Region Recruited Recruited subjects/site/month Subjects/site/month 2006 2008 Latin America 2.2 2.3 Spain 1.6 2.2 France 1.4 2.2 USA 0.8 2.1 UK 1.0 2.1 Canada 1.2 1.2 Source: Leem- Leem Recherche. Place de la France dans la Recherche Clinique Internationale Enquete 2008. Paris 10 Octobre 2008
  • 8. Recruitment Potential Region Number of #of % of Patients per Studies recruited recruited million Analyzed subjects patients citizens Latin America 161 23 341 7.5% 46 USA 181 40 433 12.9% 133.1 Australasia 185 9 653 3.1% 140.8 UK 173 16 873 5.4% 276.9 Canada 191 14 695 4.7% 442 Source: Leem- Leem Recherche. Place de la France dans la Recherche Clinique Internationale Enquete 2008. Paris 10 Octobre 2008
  • 9. Why Latin America? Quality  Quality proven regional vendors for support services: couriers, warehouses, local central labs, investigator meeting locations.  ACRP Certification and Post Graduate, University Level, Clinical Research Masters available locally for Physicians, Study Coordinators and CRAs since 2007.  Highly Controlled regulatory environment, aligned and experienced with ICH-GCP guidelines compliance (e.g. in Argentina since 1996). OUTSTANDING ENVIRONMENT FOR PERFORMING QUALITY CLINICAL RESEARCH
  • 10. Why Latin America? Costs  Reasonable costs for research monitoring and regulatory services without compromising quality.  Decreased travel to and from sites (densely populated cities)  Multiple academic, public and private hospitals in small areas.  Lower budgets due to currency exchange and over availability of PI’s, keeps cost down. Average cost is 25% less than US Trials.  Salaries and Professional fees for Researchers and Medical procedures involved in research highly competitive compared to those of USA/Canada/Europe. NON-EXPENSIVE OPERATIVE COSTS FOR CLINICAL RESEARCH SERVICES
  • 11. Why Latin America?  Similar time Zone as the USA/ Europe (5 hour difference or less)  Adequate communication & IT technology at most sites  Presence of major pharmaceutical companies.  Just two Languages spoken across the region: Spanish and Portuguese. RESEARCH REQUIREMENTS AND NEEDS ARE EASILY MET
  • 12. Why Argentina, Brazil and Chile?  Fast accrual of patients.  Small competition for patients, when comparing to European countries and USA.  High prevalence of certain diseases.  Climate, racial and social diversity.  Independent Ethics Committees which meet the norms of the ICH and GCP Guidelines.  Specific legislation for Clinical Research continuously reviewed.
  • 13. Clinical Trials in Latin America - Environmental factors-  Disparities in economic resources and access to health.  Most Health Research funded by industry.  Significant treatment naïve patient Population  Poor access to newly available (expensive) treatments and frequent enforcement for experimental treatment and procedures (control or study drug) to be provided at no cost.
  • 14. Clinical Trials in Latin America -Areas we are still working on-  Ethical Review Committees: following up, independence, transparency, competency, ethical training for members.  Research dedicated infrastructure.  Legal instruments at local or district level must synergize to stimulate research and improve quality and control.  Informed consent process strategies and tools; compliance with international + local regulations.  Lengthy approvals due to government regulations.
  • 15. Regulatory Agencies in Latin America Country Agency Website Argentina www.anmat.gov.ar Chile www.ispch.cl Colombia www.invima.gov.co/Invima/index.jsp Costa Rica www.ministeriodesalud.go.cr Bolivia www.sns.gov.bo Brazil www.anvisa.gov.br Ecuador www.msp.gov.ec Guatemala www.mspas.gob.gt Mexico www.salud.gob.mx Paraguay www.mspbs.gov.py Uruguay www.msp.gub.uy/index_1.html
  • 16. Regulatory Aspects in Southern Cone  ICH Good Clinical Practices have been adopted by Argentina, Chile ,Mexico, and Brazil. PAHO - Network for Drug Regulatory Harmonization and part of ICH Global Cooperation (Americas GCP guideline Issued).  Highly Controlled regulatory environment, aligned and experienced with ICH- GCP guidelines compliance (e.g. in Argentina since 1996).  Universal coverage to care overcomes ethical issues. Country Investigator FDA Steps GCP-MOH Witness Country Drug IND Involved Inspections Required Level Brochure Req? LAR Argentina Y N S/CRO, Y Y(1) Y IRB/IEC, ANMAT (3) Brazil Y (t) Y S/CRO, Y N Y IRB/CONEP/ ANVISA (2) Chile Y N S/CRO, IRB, Y N Y JIRB, ISP (3)
  • 17. Regulatory Overview Opportunities Challenges CTA REVIEW •CONEP and ANVISA reviews are now •Importation process in all countries may PROCESS parallel process. delay FPFV planned date •ANMAT back to adhering with 5330/97. •GICONA is a new electronic CTA submission system in CHILE. INSPECTIONS •ANMAT consolidates Inspections BY MOH program and plans for sponsor/CRO overview, ISP ongoing since 2008 ANVISA starting. ETHICS/ ICF •ANMAT incorporates GCP compliance •Questions about rational for placebo requirement for all Institutional IRBs use and trial design by ANMAT/CONEP. reviewing research •ANVISA requires treatment availability after study at no cost. OTHER New national GCP related Regulations •ANVISA Data to be exported needs to planned for the next year. have an open site with originating CA and intention to commercialize locally.
  • 18. Our tips for your strategy Early planning a must: review processes and steps involved. Selecting a CRO based in the region a plus: Regulatory affairs professionals native to the country, and familiar with culture, laws and regulations and standards. Be aware of local requirements on regulatory setup critical documentation . Plan ahead, pick sites smartly and fit them into your strategy.
  • 19. Argentina, Brazil and Chile
  • 20. Argentina
  • 21. PHARMACEUTICAL PROTOCOLS ASSESSED AND APPROVED BETWEEN 1994 – 2006 (Argentina) 250 223 200 161 158 158 144 150 150 134 116 122 119 105 95 100 80 50 0 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 1894 TRIALS (until Dec.31st 2006)
  • 22. SPONSORS PROFILE - Argentina (1994 - 2006) 1200 1083 1000 800 600 400 286 198 200 104 0 INTERNAT.PHARMAC.COMP. NATIONAL PHARMAC.COMP. INDEPENDENT RESEARCHERS CRO/SMO Source: ANMAT
  • 23. Clinical Trials According to Research Phase- Argentina- (1994-2006) 5% 3% 17% 20% 55% PHASE I PHASE II PHASE III PHASE IV BIOAVAIL. Source: ANMAT 1894 TRIALS
  • 24. Regulatory Flowchart Argentina Document Translation and Review Investigator IRB Institutional Review IEC Board Independent Ethics Committee (If IRB not GCP compliant) Ministry ANMAT of Justice Regulatory Agency (PHI) DNPDP Study Start
  • 25. Argentina- Regulatory Process Day 0 We receive Protocol, Brochure and ICF from Sponsor. Translation ordered. Day 5 Collection of signature and Protocol Agreement Page to Investigator. Start Contract Review Process by sites. Day 10 ICF Translation Finalized (Review of ICF to local requirements, start of Back translation) Day 15 Review ICF for local Requirements and further Back translation Finished submission for sponsor approval Day 20 Translation of Protocol and Brochure Finalized, sponsor approved ICF: Submission to IEC and IRB Day 40 Final Approval from IEC/ IRB. Submission of Final ICF to MINJUS. Notification to Ministry of Health City of Bs As. Day 47 Submission to ANMAT. Day 157 Approval by ANMAT. (supposing no questions asked in the middle, otherwise clock will stop)
  • 26. Chile
  • 27. Chile World Class regulatory environment including internationally recognized ethical committee guidelines. Financial Incentives by government Agency (CORFO) designed to attract clinical research. Over 1274 reliable, competitive and highly skilled researchers.
  • 28. Chile  1274 Clinical Trial Investigators  Main clinical trials carried out in Chile: Infectious Diseases, Oncology, Bronchiopulmonary and Cardiology  120 Clinical Trials approved in 2007  Patients readily recruited from both public and private health systems
  • 29. Clinical Research Investment in Chile
  • 30. Regulatory Flowchart Chile Document Translation and Review Investigator IRB Institutional Review Board IEC Independent (Jurisdiction) Ethics Committee ISP- Regulatory Agency Study Start
  • 31. Chile - Regulatory Process Day 0 We receive Protocol, Brochure and ICF from Sponsor. Translation ordered. Day 5 Collection of signature and Protocol Agreement Page to Investigator. Start Contract Review Process by sites. Day 10 ICF Translation Finalized (Review of ICF to local requirements, start of Back translation) Day 15 Review ICF for local Requirements and further Back translation Finished submission for sponsor approval Day 20 Translation of Protocol and Brochure Finalized, sponsor approved ICF: Submission to Independent IRB and Jurisdictional EC Day 80 Final Approval from IEC/IRB. Submission of Notification to ISP. Day 90 ISP does not Object Study
  • 32. Brazil
  • 33. Protocol Issues Identified by CONEP Source: CONEP 2000-2005
  • 34. Regulatory Flowchart Brazil Document Translation and Review 4-6 W Investigator ANVISA Regulatory Agency Submission of LEC CEP approval to ANVISA Local Ethics Committee Product Importation CONEP National Ethics Committee Study Start
  • 35. Regulatory Timelines in Brazil Day 0 Receipt of Protocol, Brochure and ICF from Sponsor. Translations ordered Day 5 Collection of signature and Protocol Agreement Page to Investigator. Start Contract Review Process by sites. Day 10 ICF Translation Finalized (Review of ICF to local requirements, start of Back translation) Day 15 Review ICF for local Requirements for Back translation Finished submission for sponsor approval Day 20 Translation of Protocol and Brochure Finalized, sponsor approved ICF: Submission to IEC and IRB. Day 70 Submission to ANVISA/ CONEP – The EC submits it to CONEP. Ok, if EC don´t ask for some clarifications. If it is applicable, depending on the queries, we should answer within 5 days or less. Day 240 Final Approval from ANVISA/ CONEP
  • 36. Contact us Echeverría 3989 1172 South Dixie Hwy Apt. 2 “B”- Buenos Aires City Suite# 442 - Coral Gables C1430BTL FL33146 USA ARGENTINA TEL: +54 11 4553 2682/4554 9346 FAX: +54 11 4554 8933 Anne Blanchard, CCRA, Managing Partner anne@blanchardyasociados.com.ar anne74@ciudad.com.ar www.blanchardyasociados.com.ar
  • 37. Find out more, contact us! Blanchard & Asociados Blanchard & Associates Echeverría 3989 – 2 B 1172 South Dixie Hwy Buenos Aires Suite# 442 Coral Gables C1430BTL FL33146 ARGENTINA USA TEL: +54 11 4553 2682/ 4554-9346 FAX: +54 11 4554 8933 Anne Blanchard, CCRA, CEO anne@blanchardyasociados.com.ar anne74@ciudad.com.ar www.blanchardyasociados.com.ar