BRAZILBRAZIL
Brazil Clinical Development
Profile
©2014 Industry Standard Research www.ISRreports.com
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Report OverviewIn this report, ISR provides insight into the clinical trial regulation and development environment, sponsor and
service provider activities, and population “health status” for Brazil.
Methodologies:ISR gathered content for this report via an exhaustive secondary research effort and from company profile
questionnaires that were distributed to CROs profiled in this report.
Q1, 2014Publication Date
79Pages
56Charts and Graphs
Report Structure: 1. Introduction
2. Brazilian Health Statistics
3. Clinical Trial Overview and Trial Metrics
4. Profile of Domestic Clinical Service Providers
5. Brazil Pharma/CRO Associations
6. International CROs Operating in Brazil
Valuable for: Clinical Operations, Medical Directors, Patient Recruitment,
Site Selection, Portfolio Management
What you will learn in this report:
How you can use this report:
• How population health status, regulations and clinical trial activity, and international and domestic company partnerships make Brazil one of the top emerging global pharmaceutical markets
• Insights from domestic service provider
organizations on conducting clinical trials in Brazil
• Clinical trial operational metrics for Brazil-only clinical studies
• Compiled lists and contact details for domestic and international service providers in Brazil
• Understand how Brazil compares to other countries on a variety of health condition scales so the reader can best consider the areas in which Brazil may be beneficial as a trail site
• Understand the legal, logistical, and regulatory details for conducting Brazilian trials, and illustrate the benefits and drawbacks of conducting trials in Brazil
NEXT: Table of Contents and Sample Pages
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Table of Contents
Copyright and Usage GuidelinesMethodology and SourcesIntroductionBrazil Health Statistics
Health status summary
Life expectancy
Cancer incidence rate
Female breast cancer incidence
Male prostate cancer incidence
AIDS incidence
HIV prevalence
Tobacco consumption
Alcohol consumption
Prevalence of diabetes – adults
Prevalence of dementia
Prevalence of obesity – adults
Practicing doctors
Health expenditure per capita
Total health expenditure as a share of GDP
Clinical Trial OverviewRegulatory overview
Clinical trial legislation
Clinical Trial Activity
Number of Clinical Trials
Clinical trials, by phase
Study type distribution (e.g. interventional)
Interventional trials, by phase
Observational trials, by phase
Industry-funded study type distribution
Industry-funded interventional trials, by phase
Industry-funded observational trials, by phase
Average Length of Clinical Trials
Average trial length, by phase
Average interventional trial length, by phase
Average observational trial length, by phase
Average industry-sponsored interventional trial length, by phase
Average industry-sponsored observational trial length, by phase
Projected vs. actual ongoing trial length, by phase
Projected vs. actual ongoing interventional trial length, by phase
Projected vs. actual ongoing observational trial length, by phase
Projected vs. actual ongoing industry-sponsored interventional trial length, by phase
Projected vs. actual ongoing industry-sponsored observational trial length, by phase
Average Clinical Trial Enrollment
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Average enrollment by phase
Interventional enrollment, by phase
Observational enrollment, by phase
Industry-sponsored, interventional trial enrollment, by phase
Industry-sponsored, observational trial enrollment, by phase
Selected Sponsor Distribution of Clinical Trials
Funding Source Distribution of Trials
Total funding source distribution of trials
Funding source distribution of phase I trials
Funding source distribution of phase II trials
Funding source distribution of phase III trials
Funding source distribution of phase IV trials
Domestic service provider capabilities
Domestic Clinical Service ProvidersCIDP Biotech - Brazil
Background / History
Regulation and ethic committee
GC - 2
Background / History
Company Profile Responses
Map of clinical activity
Press Release
HRPC
Background / History
Intrials
Background / History
Delays in site enrollment
Phases of operation breakdown
Press Release
Medicamenta MRS
Background / History
Newco Trials
Background / History
PGS Medical Statistics
Background / History
PHC – Consulting and Scientifc
Background / History
Company Profile Responses
Company organization
Article from Exame Magazine
Techtrials
Background / History
Company Profile Responses
Oracle partnership description
Domestic Service Provider Contact ListBrazil Pharma/CRO AssociationsInternational CROs operating in BrazilAbout Industry Standard Research
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Introduction
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Introduction
Welcome to ISR’s second Investigator Payments report highlighting Europe’s clinical trial compensation. In this report, ISR wanted to gain a better understanding of what drives investigator payments so that sponsors and CROs can benchmark their payment levels and better plan for study costs.
Determinants of investigator payments come in many forms such as therapeutic area, compound orientation, trial complexity, and patient needs. Is there a one-size-fits-all formula that can be applied uniformly across studies to produce the most effective compensation plan? Perhaps not, but by using this array of compensation averages provided by site personnel and by understanding their non-monetary motivations for trial participation, ISR believes a sponsor or CRO can recruit and retain high quality sites without breaking the budget.
This is a site-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR ([email protected]).
Sample Page
Brazil’s population is approximately 200 million and represents enormous potential for the pharmaceutical industry. The country is beginning to build a reputation for high-quality clinical trials and biodiversity, and is attracting multinational pharmaceutical companies as it continues to develop its domestic providers as well.
According to IMS Health’s Medicines Outlook Through 2016 Report, the pharmaceutical mar-ket in Brazil has experienced, on average, a 15.6% compound annual growth rate (CAGR) from 2007-2011. IMS forecasts that Brazil will experience a CAGR of 12-15% from 2012-2016. It is also estimated that Brazil’s pharmaceutical spend per capita will be $180.
The Brazilian pharmaceutical market does pose a number of challenges due to its diverse nature. A challenge for foreign players planning to enter the market is the legal framework of the country. This forces the companies into partnering with local companies, resulting in profit and control sharing. The legal and regulatory framework for patents is limited, leading to a lack of protection for intellectual property rights.
In the process of writing this report, ISR reached out the CROs profiled in this report. Question-naires were sent to contacts within these companies that asked questions regarding the com-pany’s profile, the benefits and shortcomings of conducting trials in Brazil, and trends they’ve noticed in those planning to outsource clinical studies in Brazil. Not all of the CROs profiled in this report provided answers to the questionnaire that was sent.
The complete responses from the CROs that responded are included in their entirety in this re-port. However, there were a few trends ISR noticed in the responses that we believe are worth highlighting in this portion of the report. Primarily, ISR noticed that regulatory related concerns are the primary concerns respondents voiced with regard to conducting clinical trials in Brazil.
The question posed by ISR was: “What are the challenges in conducting a trial in Brazil?” Some of the responses received are shown below:
“The main challenge is to improve regulatory submission timelines.”
“Regulatory approvals timing”
“The current regulatory scenario shows that depending on the project type it could take around 7-9 months for having the study approved by all required regulatory agencies (CEP, CONEP and ANVISA).”
Timeline issues are typically a main concern in clinical research and, within the Brazilian contract research market, regulatory issues are a major factor contributing to timeline delays. Respondents from the domestic Brazilian CROs realize regulatory delays associated with con-ducting clinical trials in Brazil are substantial and often reach out to clients to make them aware of the delays that could be experienced.
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Brazil Health Statistics
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Female breast cancer incidenceThe following chart, from the Health at a Glance OECD 2011 report, shows age-standardized female breast cancer incidence rates, 2009 (or nearest year)� Brazil reports a rate of 42�3 per 100,000 females� This number is lower than the OECD average of 71�6�
21.6 22.9
27.2 28.3
36.2 38.9 40.1 41.0 42.3 42.7 43.2 44.9
48.9 50.2
53.4 57.9
60.0 61.0
65.5 67.7
69.9 71.6
76.0 76.2
81.8 82.3 82.7 83.2 84.8 86.2 86.3 86.6 87.9 89.1 89.4 89.4
93.9 96.8 96.8
99.7 109.4
0 20 40 60 80 100 120
China India
Mexico Turkey
Indonesia Korea Chile
South Africa Brazil
Japan Russian Federation
Greece Poland Estonia
Slovak Republic Hungary Portugal
Spain Slovenia
Czech Republic Austria OECD
United States Norway
Germany Luxembourg
Sweden Canada
Australia Iceland
Italy Finland
United Kingdom Denmark
Switzerland New Zealand
Ireland Netherlands
Israel France
Belgium
Age-standardized rates per 100,000 population
Female breast cancer incidence The following chart, from the Health at a Glance OECD 2011 report, shows age-standardized female breast cancer incidence rates, 2009 (or nearest year). Brazil reports a rate of 42.3 per 100,000 females. This number is lower than the OECD average of 71.6.
©2014 Industry Standard Research
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Clinical Trial Overview
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Regulatory overviewAccording to SOMO’s Putting Contract Research Organisations on the Radar, the Brazilian regulatory agency ANVISA or Agência Nacional de Vigilância Sanitária (the Brazilian equivalent of the United States FDA) changed the regulatory process to expedite the regulatory approval of multicenter clinical trials in 2009� Today, only local ethics committees of the coordinator sites have to approve the study instead of all local ethics committees that have jurisdiction over each investigative site involved� After this approval is granted, the National Ethics Committee (CONEP) and ANVISA are approached simultaneously for approval� ANVISA is also the agency that gives approval for importation�
SOMO also goes on to reveal there are no regulatory requirements to disclose the conditions of the contracts between the sponsors of the study and the CROs, or between the sponsors and the principal investigators, to the ethics committees� ANVISA has access to the conditions but it is not used to evaluate whether the contractual arrangements protect the rights of the research participants�
SOMO’s Brazil regulatory flowchart
Putting Contract Research Organisations on the Radar
CROs in case study countries 45
The choice of the coordinator site is now crucial as the approval for all investigators sites is now in the hands of one local ethics committee. If used appropriately, the new legislation should not weaken the protection of clinical trial participants. However, in an interview, a member of the National Ethics Commission expressed concern and emphasised the need to monitor the implementation of the new process.125 The interviews with CROs indicate that the speed of proposal approval by the ethics committees is an important decisive factor in selecting the coordinating centre.126
Figure 5: Regulatory flowchart – Brazil127
Source: Business Insights.
The first Brazilian regulation that mentions the word CRO (known as ORCP in Brazil) is the RDC number 39, which was approved on 5 July 2008. This regulation defines the concept of CRO and its obligations. Like in Argentina, the only requirement is that the CROs obtain a license to operate, as any other health provider. ANVISA does not register a CRO until they present a project to the regulatory agency.
Contrary to the situation in Argentina, there is no obligation to disclose the conditions of the contracts between the sponsors of the study and the CROs, or between the sponsors and the principal investigators, to the ethics committees. This means that ECs cannot include the lines of responsibility in their judgement when deciding whether to allow a clinical trial to proceed. ANVISA has access to this information, but it is not used to evaluate whether the contractual arrangements protect the rights of the research participants.
For an overview of the main legislation regarding clinical trials in Brazil, see Table 10.
125 Brasília, 9 September 2010. 126 Interview clinical investigator, Sao Paulo, 17 August 2010. 127 Emerging Clinical Trial Locations. Market dynamics and the changing healthcare and regulatory environment, Business
Insights, July 2009.
Source: SOMO
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Clinical Trial Overview
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Average interventional trial length, by phase
The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development� How to read the table: Ongoing Phase I interventional studies are projected to take, on average, 19 months to complete�
Ongoing(projected trial length)
(months)
Recently Completed Trials
(actual trial length)
(months)
Average(months)
Average(months) 32 (N=415) 22 (N=556) 26 (N=971)
Phase 1 19 (N=3) 30 (N=5) 26 (N=8)
Phase 2 15 (N=15) 23 (N=27) 20 (N=42)
Phase 3 43 (N=54) 25 (N=65) 32 (N=119)
Phase 4 31 (N=91) 22 (N=144) 25 (N=235)
No Phase 36 (N=78) 24 (N=87) 29 (N=165)
Average observational trial length, by phase
The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development� How to read the table: Ongoing observational studies are projected to take, on average, 36 months to complete�
Ongoing(projected trial length)
(months)
Recently Completed Trials
(actual trial length)
(months)
Average(months)
Average(months) 36 (N=60) 30 (N=71) 32 (N=131)
Phase 0 23 (N=1) 39 (N=1) 31 (N=2)
Phase 1
Phase 2 45 (N=1) 45 (N=1)
Phase 3
Phase 4
No Phase 37 (N=57) 29 (N=70) 32 (N=127)
©2014 Industry Standard Research
©2014 Industry Standard Research
This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR ([email protected]).
Average interventional trial length, by phase
The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development. How to read the table: Recently completed Phase I interventional studies took, on average, 30 months to complete.
Ongoing(projected trial
length)
(months)
Recently Completed Trials
(actual trial length)
(months)
Average(months)
Average(months) 22 (N=556)
Phase 1 30 (N=5)
Phase 2 23 (N=27)
Phase 3 25 (N=65)
Phase 4 22 (N=144)
No Phase 24 (N=87)©2014 Industry Standard Research
Data available in full report
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Clinical Trial Overview
www.ISRreports.com ©2014 | Brazil: Clinical Development Profile 35
Average interventional trial length, by phase
The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development� How to read the table: Ongoing Phase I interventional studies are projected to take, on average, 19 months to complete�
Ongoing(projected trial length)
(months)
Recently Completed Trials
(actual trial length)
(months)
Average(months)
Average(months) 32 (N=415) 22 (N=556) 26 (N=971)
Phase 1 19 (N=3) 30 (N=5) 26 (N=8)
Phase 2 15 (N=15) 23 (N=27) 20 (N=42)
Phase 3 43 (N=54) 25 (N=65) 32 (N=119)
Phase 4 31 (N=91) 22 (N=144) 25 (N=235)
No Phase 36 (N=78) 24 (N=87) 29 (N=165)
Average observational trial length, by phase
The table represents the average number of months trials conducted only in Brazil took (recently completed trials) or are scheduled to take (ongoing trials) by their phase of development� How to read the table: Ongoing observational studies are projected to take, on average, 36 months to complete�
Ongoing(projected trial length)
(months)
Recently Completed Trials
(actual trial length)
(months)
Average(months)
Average(months) 36 (N=60) 30 (N=71) 32 (N=131)
Phase 0 23 (N=1) 39 (N=1) 31 (N=2)
Phase 1
Phase 2 45 (N=1) 45 (N=1)
Phase 3
Phase 4
No Phase 37 (N=57) 29 (N=70) 32 (N=127)
©2014 Industry Standard Research
©2014 Industry Standard Research
This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR ([email protected]).
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Biostatistics
Clinical trial services
Data archiving/
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Data process
optimization
E-trials/E-pro
Full-service CRO
Market access
Med community access
Multilingual
Medical writing
Patient recruitment
Pharmacovigilance
Reporting & analytics
Site management
General
Allergy
Anesthesiology
Antibiotics
Antivirals
Cardiology
Dermatology
Devices & Imaging
Diabetes
©2014 Industry Standard Research
Data available in full report
Domestic service provider capabilities
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