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Brazil: Clinical Development Country Profile

  • February 2014
  • -
  • Industry Standard Research
  • -
  • 79 pages

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.

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

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-sizefits-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.

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 market 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. 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.

Table Of Contents

Brazil: Clinical Development Country Profile
Table of Contents

Copyright and Usage Guidelines ..5
Methodology and Sources ...6
Introduction .7
Brazil Health Statistics ..9
Health status summary 10
Life expectancy 11
Cancer incidence rate ..12
Female breast cancer incidence ..13
Male prostate cancer incidence ...14
AIDS incidence .15
HIV prevalence .16
Tobacco consumption ..17
Alcohol consumption ...18
Prevalence of diabetes - adults ...19
Prevalence of dementia ...20
Prevalence of obesity - adults .21
Practicing doctors 22
Health expenditure per capita .23
Total health expenditure as a share of GDP 24
Clinical Trial Overview 25
Regulatory overview .27
Clinical trial legislation .28
Clinical Trial Activity ..29
Number of Clinical Trials ...30
Clinical trials, by phase .30
Study type distribution (e.g. interventional) 30
Interventional trials, by phase .31
Observational trials, by phase ..31
Industry-funded study type distribution ..32
Industry-funded interventional trials, by phase ..32
Industry-funded observational trials, by phase ...33
Average Length of Clinical Trials ...34
Average trial length, by phase .34
Average interventional trial length, by phase ..35
Average observational trial length, by phase ..35
Average industry-sponsored interventional trial length, by phase .36
Average industry-sponsored observational trial length, by phase ..36
Projected vs. actual ongoing trial length, by phase .37
Projected vs. actual ongoing interventional trial length, by phase ..37
Projected vs. actual ongoing observational trial length, by phase ..38
Projected vs. actual ongoing industry-sponsored interventional trial length, by phase .38
Projected vs. actual ongoing industry-sponsored observational trial length, by phase ..39
Average Clinical Trial Enrollment ..40
Average enrollment by phase ..40
Interventional enrollment, by phase ...40
Observational enrollment, by phase 41
Industry-sponsored, interventional trial enrollment, by phase ...41
Industry-sponsored, observational trial enrollment, by phase 42
Selected Sponsor Distribution of Clinical Trials 43
Funding Source Distribution of Trials 44
Total funding source distribution of trials 44
Funding source distribution of phase I trials 44
Funding source distribution of phase II trials ...45
Funding source distribution of phase III trials ..45
Funding source distribution of phase IV trials ..46
Domestic service provider capabilities .47
Domestic Clinical Service Providers ...50
CIDP Biotech - Brazil ..51
Background / History ...51
Regulation and ethic committee ..52
GC - 2 .53
Background / History ...53
Company Profile Responses .54
Map of clinical activity .55
Press Release ..56
HRPC .57
Background / History ...57
Intrials ...58
Background / History ...58
Delays in site enrollment .59
Phases of operation breakdown ..59
Press Release ...60
Medicamenta MRS 61
Background / History ...61
Newco Trials ..62
Background / History ...62
PGS Medical Statistics ...63
Background / History ...63
PHC - Consulting and Scientific 64
Background / History ...64
Company Profile Responses .65
Company organization .66
Article from Exame Magazine ..67
Techtrials ..68
Background / History ...68
Company Profile Responses .69
Oracle partnership description 75
Domestic Service Provider Contact List .76
Brazil Pharma/CRO Associations 77
International CROs operating in Brazil ...78
About Industry Standard Research 79

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