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January 2015
21 countries, Area: 21 069 501 km2
Population: 590 million people Heterogeneous population Two major official Languages: Spanish and Portuguese (Brazil) Average Life expectancy 75 years Population Concentrated in Major Urban Areas such as Mexico City, Sao Paulo or Buenos Aires
Source: www.paho.org and www.unep.net
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
Country # open studies 3
Trend4
Brazil 1210
Mexico 493
Argentina 384
Chile 222
Colombia 207
Peru 137
Country # open studies 3
Trend4
Venezuela 17
Panama 55
Costa Rica 8
Ecuador 24
Uruguay 17
Bolivia 7
Paraguay 5
(3) Info captured as open studies in clinicaltrials.gov on 24 Dec 2014 and (4)
In comparison to 24 December 2013
0
200
400
600
800
1000
1200
1400
1-Aug-10 1-Aug-11
Brazil
Mexico
Argentina
Chile
Peru
Colombia
Info captured as open studies in clinicaltrials.gov last measure 02 Aug 2013
Country # Inspections (% OAI) % VAI
Brazil 39 (0%) 41%
Mexico 22 (0%) 72%
Argentina 45 (0%) 44%
Chile 9 (0%) 44%
Peru 5 (20%) 60%
Colombia 3 (0%) 33%
Panamá 1 (0%) 100%
Costa Rica 4 (0%) 25%
Paraguay 1((0%) 100%
Ecuador 2 (0%) 0%
http://www.accessdata.fda.gov/scripts/cder/CLIIL/, Total Open studies en Vlinicaltrials.gov on 26 Dec 2011
ONLY ONE COUNTRY (PERU) HAS HAD 1 OAI RESULT
IN THE LAST 11 YEARS
http://www.accessdata.fda.gov/scripts/cder/CLIIL/, Total Open studies en Vlinicaltrials.gov on 26 Dec 2011
0
5
10
15
20
25
30
35
40
45
OAI
VAI
NAI
ARGENTINA IS THE MOST INSPECTED COUNTRY IN LATIN
AMERICA, POSSIBLY CORRELATED TO PROPORTIONAL
DATA CONTRIBUTES TO FILINGS
1. Large, ethnically diverse population. 2. Increasing access to healthcare and medications. 3. Complementary to northern hemisphere sites for indications with seasonal variations (such as respiratory diseases). 4. Strong patient-doctor relationship, leading to good compliance & retention rates (minimal dropout rates). 5. Niche for emerging and neglected diseases. 6. Many significant metropolitan areas with population concentration in big cities:
Sao Paulo 11.31 m in Brazil (190.8 m) Mexico City 21.2 m in Mexico (116.2 m) Buenos Aires and Suburbs 15 m in Argentina (40.11 m) Santiago 6.1m in Chile (17 m)
OUTSTANDING ENVIRONMENT FOR
EXCELLENT RECRUITMENT PERFORMANCE
Region Recruited
subjects/site/month 2006
Recruited Subjects/site/month 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 October 2008
OUTSTANDING RECRUITMENT PERFORMANCE ONCE
SITES ARE ACTIVATED
Region Number of
Studies Analyzed
#of recruited subjects
% of recruited patients
Patients per million 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 October 2008
LOWER DENSITY OF RESEARCH STUDIES LEAVES ROOM
TO GROW MAINTAINING SUBJECTS PARTICIPATION RATES
Quality proven regional vendors for support services: couriers,
warehouses, regional and national central labs, investigator meeting
locations.
Clinical Research Professionals 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 and Brazil since 1996).
OUTSTANDING ENVIRONMENT FOR
PERFORMING QUALITY CLINICAL RESEARCH
Decreased travel to and from sites (densely populated cities).
Multiple academic, public and private hospitals in small areas.
Salaries and Professional fees for Researchers and medical
procedures involved in research highly competitive compared to
those of USA/Canada/Europe.
Reference Sites concentrating less prevalent diseases help optimize
costs and simplify site selection.
NON-EXPENSIVE OPERATIVE COSTS
FOR CLINICAL RESEARCH SERVICES
RESEARCH REQUIREMENTS AND
NEEDS ARE EASILY MET
Similar time Zone as the USA/ Europe (5 hour difference or less)
Adequate communication & IT technology at most sites
Presence of major pharmaceutical companies and CROs.
Just two Languages spoken across the region: Spanish and Portuguese.
Potential for growth of the Clinical Research activity.
Clinical Research Professionals (Investigators and Sponsors) are
organized to foster training and shape regulations for an continuously
improving environment for clinical trials.
Relatively fast inclusion of subjects once site is active.
Smaller competition for patients compared to EU countries and
USA.
High prevalence of certain diseases and big reference institutions in
densely populated cities with a long research tradition.
Climate, racial and social diversity.
Agencies and Research Ethics Committees meet ICH GCP standards
and Follow PAHO GCPs (America´s Document).
Specific legislation for Clinical Research continuously reviewed,
keeping up to the latest standards and technology.
Disparities in economic resources and access to health.
Most health research is industry sponsored.
Poor access to newly available (expensive) treatments
Frequent requirement that best proven treatment after the study to
be provided at no cost, for chronic indications.
Set up regulatory realistic timelines and awareness of involved steps
are important for sponsors to know what to expect.
Importation / exportation careful planning a must.
Placebo use rationale needed, Medical and Scientific opinion within
the research location a plus.
Research Review Committees are improving: following up,
independence, transparency, competency, clinical research ethics and
GCP training for members.
Research dedicated infrastructure such as Phase I units and Biologics
administration facilities. More are needed as research grows.
Legal instruments at local or district level must synergize to stimulate
research and continue actual oversight and improve timelines.
Focus on the question that the protocol needs to answer, not on the
Investigator fees. Follow up on protocol final results.
Country Agency Website
Argentina www.anmat.gov.ar
Chile www.ispch.cl
Colombia www.invima.gov.co
Costa Rica www.ministeriodesalud.go.cr
Bolivia www.sns.gob.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
Electronic Submissions (GICONA, NOTIVISA, ANMAT)
Increasing Oversight (ANMAT, INS, ANVISA, ISP)
Accreditation/Registration of Research Review Committees (ISP, INVIMA, ANVISA, INS, MoH Bs As Province, CONIS-CEC, Province of Cordoba, MoH Bs As City, HS in Mexico).
National Registries (ReBEC, ReNIS, RePEC, RNEC) aligned with ICTRP (PAHO-OMS)
Early planning a must: always 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.
IT TAKES TIME TO SET UP LATIN AMERICA,
BUT RECRUITMENT IS RELIABLE AND
CAN HELP COMPLETE YOUR STUDY
The slide that follows: Is based on an example of pre-registration phase III studies involving (bio)pharmaceutical products. Times may be reduced significantly if the study is a phase IV.
If you plan to include typical holiday months (January and February) in your set up period, you must know there may be delays due to lack of quorum with some committees or shortage of staff with the agencies.
Service Agreements, Insurance for Subjects and Letter of Authorization to local Representative Entity are critical documents for an efficient study start up.
IT TAKES TIME TO SET UP LATIN AMERICA,
BUT RECRUITMENT IS RELIABLE AND
CAN HELP COMPLETE YOUR STUDY
TEL: +54 11 4553 2682/ 4554-9346
FAX: +54 11 4554 8933
Anne Blanchard, CCRA, CEO
www.blanchardyasociados.com
