Brazil: Clinical Development Profile


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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.

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Brazil: Clinical Development Profile

  1. 1. EW PR EV I BRAZIL Brazil Clinical Development Profile ©2014 Industry Standard Research
  2. 2. 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. 56 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 ©2014 | Preview of: Brazil Clinical Development Profile 2
  3. 3. act with confidence Table of Contents For table of contents and additional sample pages, download the full preview from our website: ©2014 | Preview of: Brazil Clinical Development Profile 3
  4. 4. act with confidence Sample Page Introduction act with confidence 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. ©2014 | Benchmarking European Investigator Payments 6 ©2014 | Preview of: Brazil Clinical Development Profile 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 ( 4
  5. 5. act with confidence Sample Page Brazil Health Statistics act with confidence 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 ©2014 | Brazil: Clinical Development Profile 13 ©2014 | Preview of: Brazil Clinical Development Profile 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 ( 5
  6. 6. act with confidence Sample Page Clinical Trial Overview act with confidence 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, ©2014 | Brazil: CROs obtain a license 27 as any other health provider. ANVISA does not register a CRO until they present a project to the ©2014 | Preview of: Brazil Clinical Development Profile 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 ( Contrary to the situation in Argentina, there is no obligation to disclose the conditions of the 6
  7. 7. act with confidence Sample Page For table of contents and additional sample pages, download the full preview from our website: ©2014 | Preview of: Brazil Clinical Development Profile 7
  8. 8. act with confidence Ordering Information For pricing and ordering information, please visit our website: Save on this, or any ISR report, by registering a free account Register now • Receive a $250 instant credit towards any ISR report • Earn 10% credit towards all future purchases • Receive advanced notifications on ISR’s latest reports and free resources 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.    For more information about our off-the-shelf intelligence and custom research offerings, please visit our Web site at www., email, or follow us on twitter @ISRreports. ©2014 | Preview of: Brazil Clinical Development Profile 8
  9. 9. The ISR Difference act with confidence Custom-quality syndicated market research ISR's Reports vs. The Common Syndicated Report How confident are you? Research methods Mostly primary research; always appropriate for the topic vs. vs. One size fits all; usually publically available data Data Collection ISR's proprietary data collection tools and channels support fast, high quality data collection vs. Struggle to recruit the right targets and enough of them Respondents Sophisticated screening ensures genuine decision-makers vs. Undisclosed methodologies and respondent demographics Sample Sizes Robust sample sizes that instill confidence vs. Often insufficient industry representation that leaves you defending results Analysts Decades of experience means more insights that are immediately usable vs. vs. Junior analysts capable of reporting numbers ©2013 | Preview of: Benchmarking the Pharma Industry’s HEOR Profile ©2014 | Preview of: Brazil Clinical Development Functions 9