Emerging Clinical Trial Locations -Latin America: Market dynamics and the changing healthcare and regulatory environment

Table of Contents

Executive summary

• Introduction
• Conducting clinical trials in emerging markets
• Latin America

Chapter 1 Introduction

• Summary
• Introduction
• Generic competition
• Intellectual property protection
• Managing regulatory compliance
• Cost containment and government funding restrictions
• Obtaining and maintaining competitive advantage
• Recruitment and retention of a skilled workforce
• Improvement to R&D productivity
• High risks and costs associated with drug development
  • Escalating costs of clinical trials
  • Global increase in the number of clinical trials conducted
  • Longer R&D timelines
  • Increased attrition rates during R&D
• Clinical trial study design and planning
• Clinical trial study design
• Clinical trial study protocol
• Clinical trial sponsors
• Identifying and recruiting patients
• Role of CROs
• Information technology and new technology platforms
• Drivers of development
  • Advantages associated with EDC
  • Advantages of electronic Clinical Trial Management Systems
  • (CTMS)
  • Cost saving
• Issues and challenges
  • Electronic records and signatures
  • Integration and linkage of electronic systems
  • Security and confidentiality of patient data

Chapter 2 Conducting clinical trials in emerging markets

• Summary
• Introduction
• Market drivers
• Rapid recruitment of patients and clinical trial investigators
• Significant cost benefits
• Improving transparency and efficiency of regulatory systems
• Harmonization and standardization of regulatory requirements
• Expansion of CROs
• Conducive hospital infrastructure and healthcare systems
• Enhanced clinical site effectiveness
• Future commercial value
• Key barriers
• Concerns over the clinical trial transparency
  • Publication bias
  • Selective reporting
  • Duplicate publication
  • Conflict of interest
• Availability of demographic and epidemiology data
• Critical components concerning capacity building
• Assimilation of individual national regulations and guidelines
  • United States
  • Japan
  • European Union
• Language translation
• Ethical challenges
  • Health needs of the population under study
  • Respect for potential and enrolled subjects
  • Ethical oversight
  • Lack of review by institutional review board (IRB)
  • Absence of informed consent
  • Scientific validity
• Inadequate protection of intellectual property
• Clinical trial logistics
  • Import licenses and applications
  • Customs regulations
  • Storage, handling and distribution
• Selecting an appropriate CRO
• Patient enrolment
  • Site selection
  • Site activation
  • Patient recruitment

Chapter 3 Latin America

• Summary
• Introduction
• Geographic
  • Brazil
  • Argentina
  • Mexico
• Political
  • Brazil
  • Argentina
  • Mexico
• Economic
  • Brazil
  • Argentina
  • Mexico
• Market dynamics
• Vital statistics - Brazil
  • Population statistics
  • Epidemiology and prevalence of major disease
• Vital statistics - Argentina
  • Population statistics
  • Epidemiology and prevalence of major diseases
• Vital statistics - Mexico
  • Population statistics
  • Epidemiology and prevalence of major disease
• Pharmaceutical market
• CRO market
• Clinical trial market
• Market drivers
• Significant cost savings
• High concentration of population in urban centers
• High ethnic diversity
• High patient enrolment, compliance and retention rates
• A major growing Latin American pharmaceutical market
• Reverse seasons advantages
• Commonality of Spanish language
• Accessibility to medical professionals and clinical trial investigators
  • National clinical trials register - Argentina
• Key barriers
• Concerns over intellectual property protection
• Inconsistent regulatory environment
• Cultural challenges and issues
• Healthcare
• Healthcare system- Brazil
• Hospital resources - Brazil
• Healthcare system - Argentina
• Hospital resources - Argentina
• Healthcare system - Mexico
• Hospital resources - Mexico
• Regulation and guidelines
• Regulatory authorities
  • The Pan American Network for Drug Regulatory Harmonization (PANDRH)
  • ANVISA - Brazil
  • Brazilian Research Ethics Commission (CONEP)
  • ANMAT - Argentina
  • SSA - Mexico
  • COFEPRIS - Mexico
• Clinical trial regulation
  • Brazil
  • Argentina
  • Mexico
• Guidelines
  • Good Clinical Practices: Document of the Americas
  • The Buenos Aires Declaration on Ethics and Clinical Trials
  • Import licenses for drugs in clinical trials - Mexico
• Outlook

Chapter 4 Appendix

• Introduction to clinical trials
• Clinical trial phases
  • Phase I
  • Phase II
  • Phase III
  • Phase IV
• What is a clinical trial
• Clinical trials of pharmaceutical agents
• Types of clinical trial
  • Pilot studies
  • Proof of concept (PoC) trials
  • Randomized clinical studies
  • Controlled clinical trials
  • Parallel studies
  • Parallel group trials
  • Cohort studies
  • Case control studies
• Role of the chief investigator
• Clinical trial protocol and procedure
• Determination of the clinical trial size
• Role of the coordinating centre and trials unit
• Role of the trial coordinator
• The trial principle investigator
• Forms and data management
• Trial data analysis and evaluation
• Ethical issues and conduct of clinical trial research
• Interpretation and publication of clinical trial results
• Principle regulatory agencies
• The European Agency for the Evaluation of Medicinal Products (EMEA)
• The United States Food and Drug Administration (US FDA)
• Japanese Ministry of Health, Labor and Welfare (MHLW)
• Methodology statement
• Primary Data and Information Gathering
• Secondary data and information gathering
• Definitions of Product-Life Cycle stages
• Glossary of abbreviations and acronyms

List of Figures

• Figure 1.1: Key issues facing Pharma and Biotech companies
• Figure 1.2: Cost of bringing a drug to market ($m), 1975-2008
• Figure 1.3: Pharmaceutical R&D expenditure ($bn), 2004-2009e
• Figure 1.4: Biotechnology R&D expenditure ($bn), 2004-2009e
• Figure 1.5: Cost of clinical trials in the US ($bn), 2005-2011e
• Figure 2.6: Comparison of locations across selected countries
• Figure 2.7: Korean Food and Drug Administration (KFDA) Approval Process
• Figure 2.8: CRO Segment Leaders
• Figure 2.9: Enhanced clinical site effectiveness (patients per site) in the emerging countries
• Figure 2.10: Fewer ineffective sites in the emerging countries
• Figure 2.11: Critical components for capacity building/conducting clinical trials
• Figure 2.12: Assessing clinical trial location feasibility
• Figure 2.13: CRO selection criteria
• Figure 3.14: Population projection (' 000s) - Brazil, 2000-2050
• Figure 3.15: Population projection (thousands) - Argentina, 2000-2050
• Figure 3.16: Population projection (thousands) - Mexico, 2000-2050
• Figure 3.17: Forecast growth ($bn) Latin America pharmaceutical market, 2008-2013
• Figure 3.18: Latin America pharmaceutical market 2008
• Figure 3.19: No. of clinical trials in Latin America, 2000-2008
• Figure 3.20: Clinical trials by phase in Latin America (number of trials), 2008
• Figure 3.21: Registered Research Ethics Committees (REC) by Region - Brazil 2008
• Figure 3.22: Regulation of clinical trials in Latin America 2007
• Figure 3.23: Regulatory flowchart - Brazil
• Figure 3.24: Regulatory flowchart - Argentina
• Figure 3.25: Regulatory flowchart - Mexico

List of Tables

• Table 2.1: Demographics of selected emerging markets, 2007
• Table 2.2: Ethical principles & their application for research
• Table 3.3: Ten leading causes of death, Argentina, 2003
• Table 3.4: Ten leading causes of death, Mexico, 2004 (compared to rate in 2000)
• Table 3.5: Top 10 pharma companies ($m) in Brazil, Argentina, and Mexico, 2008
• Table 3.6: Major CROs operating in Latin America, 2009
• Table 3.7: Ten leading causes of death in Brazil, 2003
• Table 3.8: Snapshot of hospitals in Argentina, 2007