More Related Content More from Industry Standard Research (20) Brazil: Clinical Development Profile2. act with confidence
Report Overview
In 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.
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Charts and Graphs
Q1,
2014
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
Publication Date
79
Pages
Valuable for:
Clinical Operations, Medical Directors, Patient Recruitment,
Site Selection, Portfolio Management
What you will learn in 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
How you can use this report:
• 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
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Sample Page
Introduction
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Introduction
Brazil’s population is approximately 200 million and represents enormous potential for the
Welcome to ISR’s second Investigator Payments report highlighting Europe’s clinical
pharmaceutical industry. The country is beginning to build a better understanding of clinical
trial compensation. In this report, ISR wanted to gain a reputation for high-quality
trials and biodiversity, and is attracting multinational pharmaceutical companies as it continues
what drives investigator payments so that sponsors and CROs can benchmark their
to develop its domestic providers as well.
payment levels and better plan for study costs.
According to IMS Health’s Medicines Outlook Through 2016 Report, the pharmaceutical marDeterminants of investigator payments come in many forms such as therapeutic
ket in Brazil has experienced, on average, a 15.6% compound annual growth rate (CAGR) from
area, compound orientation, trial complexity, and patient needs. Is there a one-size2007-2011. IMS forecasts that Brazil will experience a CAGR of 12-15% from 2012-2016. It is
fits-all formula that can be applied uniformly across studies to produce the most
also estimated that Brazil’s pharmaceutical spend per capita will be $180.
effective compensation plan? Perhaps not, but by using this array of compensation
averages pharmaceutical personnel and by understanding their non-monetary
The Brazilianprovided by site market does pose a number of challenges due to its diverse
motivations for for participation, planning to a sponsor or CRO can recruit and
nature. A challengetrial foreign playersISR believes enter the market is the legal framework of
the country. This forces thewithout breaking the budget. local companies, resulting in profit
retain high quality sites companies into partnering with
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. Questionnaires were sent to contacts within these companies that asked questions regarding the company’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 report. 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 conducting 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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Sample Page
Brazil Health Statistics
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Female breast cancer incidence
Female breast cancer incidence
The following chart, from the Health at a Glance OECD 2011 report, shows ageThe following chart, from the Health at a Glance OECD 2011 report, shows age-standardized female
standardized incidence rates, 2009 (or nearest year). Brazil reports a rate of 42.3
breast cancer female breast cancer incidence rates, 2009 (or nearest year)� Brazil per 100,000 females.
This number isof 42�3 than100,000 females� This 71.6.
reports a rate lower per the OECD average of number is lower than the OECD
average of 71�6�
109.4
Belgium
France
Israel
Netherlands
Ireland
New Zealand
Switzerland
Denmark
United Kingdom
Finland
Italy
Iceland
Australia
Canada
Sweden
Luxembourg
Germany
Norway
United States
OECD
Austria
Czech Republic
Slovenia
Spain
Portugal
Hungary
Slovak Republic
Estonia
Poland
Greece
Russian Federation
Japan
Brazil
South Africa
Chile
Korea
Indonesia
Turkey
Mexico
India
China
99.7
96.8
96.8
93.9
89.4
89.4
89.1
87.9
86.6
86.3
86.2
84.8
83.2
82.7
82.3
81.8
76.2
76.0
71.6
69.9
67.7
65.5
61.0
60.0
57.9
53.4
50.2
48.9
44.9
43.2
42.7
42.3
41.0
40.1
38.9
36.2
28.3
27.2
22.9
21.6
©2014 Industry Standard Research
0
20
40
60
80
100
Age-standardized rates per 100,000 population
120
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Sample Page
Clinical Trial Overview
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Regulatory overview
According 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
Putting Contract of the coordinator sites have to
ethics committeesResearch Organisations on the Radarapprove 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�
The choice of on coordinator site is no crucial as requirements to disclose the
SOMO also goes the to reveal there arenowregulatory the approval for all investigators sites is now in
the hands the contracts between the sponsors of the study and new legislation
conditions of of one local ethics committee. If used appropriately, thethe CROs, or should not
weaken the protection of clinical trial investigators, to the ethics interview, a member of the
between the sponsors and the principalparticipants. However, in an committees�
National Ethics to the conditions but it is not used emphasised the need to
ANVISA has accessCommission expressed concern and to evaluate whether the monitor the
125
implementation of the new process. The interviews with CROs indicate
contractual arrangements protect the rights of the research participants� that the speed of
proposal approval by the ethics committees is an important decisive factor in selecting the
126
coordinating centre.
SOMO’s Brazil regulatory flowchart
Figure 5: Regulatory flowchart – Brazil
Source: Business Insights.
127
Source: SOMO
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 Clinical Development Profile to operate,
www.ISRreports.com ©2014 | Brazil: CROs obtain a license
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as any other health provider. ANVISA does not register a CRO until they present a project to the
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regulatory agency.
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 (info@ISRreports.com).
Contrary to the situation in Argentina, there is no obligation to disclose the conditions of the
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About Industry Standard Research
Industry Standard Research (ISR) is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise.
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