List of Figures and Tables

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1 1.01 p p p p p p p p p p p p p p p p p p p. 59 Global Pharmaceutical Sales, Major World Markets: Population Size and Sales Growth Global Pharma Sales by Region: Pharmaceutical Sales by Region: Share of Worldwide Market Global Pharma Sales Growth by Region Top 10 Pharma Markets: 2003, 2007, 2011 Ten Fastest Growing Pharmaceutical Markets: Ethical Pharmaceutical Sales: Selected Emerging Markets Ethical Pharmaceutical Sales: Total PhRMA-member Company Sales, Ethical Pharmaceutical Sales: Total PhRMA-member Company Sales, Ethical Pharmaceutical Sales: Growth Rate, National Health Expenditures and Their Share of Gross Domestic Product: (Projected) U.S. Pharmaceutical Spending Growth vs. Total Healthcare Spending Growth: Growth in Prescription Drug Spending: Overall Consumer Price Index (CPI) and Medical-specific Consumer Price Index (MCPI): Major European Pharmaceutical Sales Pharmaceutical Market in Canada: Pharmaceutical Market in Latin America 2005 Pharmaceutical and Medicine Manufacturing in Africa

2 x 1.20 p p p p p p p p p p p p p p p p p p p p p p p p p p p p. 73 Top 10 Pharmaceutical Companies: 2008 Pharmaceutical Revenues Top 10 Biotechnology Companies: 2008 Revenue Worldwide Prescription Sales by Technology: Worldwide Ethical Pharmaceutical Sales: Top Therapeutic Classes, Top 10 Worldwide Drug Sales 2007 Top 10 Orphan Drug Sales Global Oncology Sales Estimate: Biologics Sales by Region 2007 Biologics Sales by Company 2007 Biologics Sales by Therapy Classes 2007 Biologics Sales Top Products Worldwide Medical Device Market: Projected Sales Through 2009 U.S. Medical Device Market: Projected Sales Worldwide Medical Device Sales: 2004 Estimated Market Share by Region Medical Device Market: Largest Treatment Areas by Total Sales, 2003 Select Medical Device Manufacturers: Total Device Revenues, 2008 Medical Devices: Worldwide and U.S. Revenues Generic Pharmaceutical Market: Total Worldwide Sales, Generic Pharmaceutical Market: Total U.S. Sales, Top 10 Generic Companies: 2008 Revenue Top 10 Generic Molecules by 2007 Sales Generics Percentage of Total Prescriptions Filled U.S. Prescriptions: Generic Share of Prescriptions: Generic Substitution Rates: Select Countries Sales Vulnerable to Generic Competition: Selected Top Companies Through 2012 Top Drugs Facing Generic Competition: U.S. Patent Expiration by Year Market Share Lost 12 Months After Patent Expiration

3 xi 2.01 p p p p p p p p p p p p p p p p p p p p p p p p p p p. 99 Projected R&D Spending: Pharmaceutical and Biotech Companies, R&D Spending Growth Rates: PhRMA-member Companies, A New Wave of Pipeline Growth: Projects Worldwide (Discovery Clinical) NME Approval and Domestic R&D Expenditure: World R&D Market Share: PhRMA-member Companies Domestic R&D Spending: PhRMA-member Companies, R&D Spending Abroad: PhRMA-member Companies, Top 10 Pharmaceutical Companies by R&D Spending: 2008 Top 10 Biotechnology Companies by R&D Spending: 2008 R&D Spending as a Percent of Sales: PhRMA-member Companies R&D Spending as a Percent of Sales: Distribution by Industry Type, 2009E Projected Pharma R&D as a Percent of Sales: Worldwide Spending, The Cost of Developing a Single Drug: Total Capitalized Costs, in Constant 2005 Dollars Costs per Approved Biopharmaceutical Total Spending on Clinical Collaborations: PhRMA-member Companies PhRMA-member R&D Spending: Expenditure by Function, 2006 Clinical Development: Total PhRMA-member Spending in the U.S., by Phase Spending on Development: Projected Spending, by Phase Spending on Development: Projected Spending Spending on Phase IV Trials: PhRMA-member Companies Distribution of R&D: Funding by Therapeutic Area, 2004 Distribution of R&D: Percentage of Total Funding Across Top Therapeutic Areas, Pharmaceutical R&D: Funding by Therapeutic Area, Sources of Trial Funding Industry and Government Sponsored R&D Expenditure, Sponsorship of Trials: Type of Sponsor, All Phases Sponsorship of Phase II Trials: Type of Sponsor

4 xii 2.28 p p p p p p p p p p p p p p p p p p. 108 Sponsorship of Phase III Trials: Type of Sponsor Sponsorship of Phase IV Trials: Type of Sponsor Industry Sponsorship of Trials: Top Countries with Industry Sponsorship, All trials Industry Sponsorship of Phase II Trials: Top Countries with Industry Sponsorship Industry Sponsorship of Phase III Trials: Top Countries with Industry Sponsorship Industry Sponsorship of Phase IV Trials: Top Countries with Industry Sponsorship Total NIH Grants: Grants to All Research Interests, NIH Grants to Foreign Countries: Grants to All Research Interests, International NIH Grant Recipients: Top Recipients by Country, 2008 NIH Sponsorship of Trials: Top Countries with NIH Sponsorship, All trials NIH Sponsorship of Phase II Trials: Top Countries with NIH Sponsorship NIH Sponsorship of Phase III Trials: Top Countries with NIH Sponsorship NIH Sponsorship of Phase IV Trials: Top Countries with NIH Sponsorship NIH Grants by Disease: Estimated Distribution of Funding by Therapeutic Area, 2008 Federally Funded Clinical Research: Distribution of 2007 Funding by Source New NIH Grants: Type I Research Project Grants, NIH Funding by Region: Top 10 States and International by Total Grant Amount, 2007 NIH Funding per Capita: Top 10 States, p p p. 119 Clinical Trial Initiations: Based in FDA-1572, Worldwide Clinical Trials: Estimated Ongoing Phase I-III Trials, A New Wave of Pipeline Growth: Projects Worldwide (Discovery Clinical)

5 xiii 3.04 p p p p p p p p p p p p p p p p p p p p p p p p p. 131 Distribution of Clinical Development: Active Projects by Phase, as of December 2008 Clinical Trials per NDA: Mean Number of Trials in Drugs Reaching Approval by Phase NMEs/BLAs Submitted to the FDA by Year The Clinical Development Cycle The Pharmaceutical Development Cycle: Total Cycle Time: 20 Years Chance of IND-accepted Drug Entering a Development Phase Chance of Drug Completing Each Development Phase NCE Approval Success Rates by Therapeutic Class Sponsor Development Time Goals Causes of Study Initiation Delays in the United States Causes of Study Initiation Delays in Europe Enrollment Delays in the United States: Distribution of Delays in Site Enrollment Timeliness Enrollment Delays: Distribution of Delays in Site Enrollment Timeliness Drugs in Development by Therapeutic Area: Total Active INDs at Year-end 2007 for Top Categories Therapeutic Area Growth: Growth in Number of Active INDs, Number of Active INDs at Year-end, 2006 Distribution of Commercial and Non-commercial INDs, 2006 Top Six Pharmaceutical Pipelines: Total Drugs in Development, Including Collaborations, 2008 R&D Pipelines of Top Companies: Number of Total Drugs in Development, 15 Largest Pipelines R&D Pipelines of Top Companies: Number of Own-drugs in Development, 15 Largest Pipelines Top Countries in Trials: Most Listed Companies Licensing Among Top 10 Pharmas The Potential Cost of Delays: Worldwide Sales for the Top Five Blockbuster Drugs, 2007 Comparing Development Times: Mean Time from First Synthesis to Approval for NMEs Approved, 2001 Clinical and Approval Times: Total Time,

6 xiv 3.29 p p p p p p p p p p p p p p p p p p p p p p. 142 Comparing Cycle Times by NCE Type: Average Time in Years Average Clinical Development Time: Median Total Time from IND to Approval Average Cost of One Day of Clinical Development, 2005 Mean Exclusivity for First-in-class Approvals Average Clinical Development Time: Mean Total Time by Therapeutic Area and Phase Average Clinical Development Time: Mean Total Time by Therapeutic Area and Phase, Successful Trials Average Clinical Development Time: Mean Total Time by Therapeutic Area and Phase, Unsuccessful Trials Average Clinical Development Time: Mean Total Time by Company Size and Phase, all TAs Time to Completing Phase for Successful and Failed Trials Increases in Phase I Spending Improve Phase III Success Scope of Clinical Projects: Mean Number of Subjects and Sites per Trial Differences in Phase I Trials: Index of Number of Subjects in Phase I Trials for Selected TAs Differences in Phase I Trials: Index of Number of Sites in Phase I Trials for Selected TAs Differences in Phase II Trials: Index of Number of Subjects in Phase II Trials for Selected TAs Differences in Phase II Trials: Index of Number of Sites in Phase II Trials for Selected TAs Differences in Phase III Trials: Index of Number of Subjects in Phase III Trials for Selected TAs Differences in Phase III Trials: Index of Number of Sites in Phase III Trials for Selected TAs Trials by Phase in Russia: Drug and Biological Trials Listed on Clinicaltrials.gov Trials by Phase in Australia: Drug and Biological Trials Listed on Clinicaltrials.gov Trials by Phase in China: Drug and Biological Trials Listed on Clinicaltrials.gov Trials by Phase in India: Drug and Biological Trials Listed on Clinicaltrials.gov Trials by Phase in France: Drug and Biological Trials Listed on Clinicaltrials.gov

7 xv 3.51 p p p p p p p p p p p p p p p p p p p p p p p. 154 Trials by Phase in Poland: Drug and Biological Trials Listed on Clinicaltrials.gov Trials by Phase in Spain: Drug and Biological Trials Listed on Clinicaltrials.gov Trials by Phase in the United Kingdom: Drug and Biological Trials Listed on Clinicaltrials.gov Trials by Phase in Germany: Drug and Biological Trials Listed on Clinicaltrials.gov Rising Project Complexity: Mean Number of Procedures per Patient, Rising Project Complexity: Mean Number of Procedures per Patient by Phase, Clinical Trial Complexity by Trial Phase: U.S., Western Europe, Eastern Europe, Asia, Index of Cost of Conducting Trials: Select Countries, 2007 Cost of U.S. Clinical Trials: Mean Cost per Patient, by Phase, Cost of U.S. Clinical Trials: Median Cost per Patient, by Therapeutic Area, Mean Cost per Patient in Clinical Trials: U.S., Western Europe, Eastern Europe, Asia, Mean Cost per Patient by Therapeutic Area: U.S., Western Europe, Eastern Europe, Asia, Mean Cost per Patient by Therapeutic Area: U.S., Western Europe, Eastern Europe, Asia, Sample Patient Reduction from Adaptive Trial Approach Drugs in Pediatric Trials: Distribution of Projects by Phase Drugs in Pediatric Trials: Distribution of Projects by Phase, 2008 Top Five Therapeutic Areas in Pediatric Development Top Five Sponsors Conducting Pediatric Trials by Number of Pediatric Development Projects Grants of Pediatric Exclusivity by Company Grants of Pediatric Exclusivity by Type Written Requests for Pediatric Exclusivity Written Requests by FDA Review Division Proposed Pediatric Study Requests by FDA Review Division

8 xvi 3.74 p p. 155 Studies Requested, Pediatric: Patients Needed Post-marketing Commitments: Pediatric Components 5.01 p p p p p p p p p p p p p p p p p p p p p p p p p. 244 Factors Most Often Causing Study Delays in the United States Factors Most Often Causing Study Delays in Europe Factors Most Often Causing Study Delays in Asia-Pacific Enrollment Delays: Distribution of Delays in Site Enrollment Timeliness Enrollment Delays in the United States Enrollment Delays in Europe Factors That Could Best Prevent Future Delays in the United States Factors That Could Best Prevent Future Delays in Europe Factors That Could Best Prevent Future Delays in Asia-Pacific EDC as a Factor That Could Best Prevent Future Delays Factors That can Best Prevent Future Study Delays Factors That Could Best Prevent Future Delays How Has Sponsor Performance in the United States Changed in the Past Three Years With Regards to: How Has Sponsor Performance in Europe Changed in Past Three Years with Regards to: How Has Sponsor Performance in Asia Pacific Changed in Past Three Years with Regards to: Average Rating for the Typical Sponsor in the United States Average Rating for the Typical Sponsor in Europe Top Rated Sponsors in the United States Top Rated Sponsors in Europe Highest Frequency as a Top Three Rated Sponsor Across 27 Relationship Attributes in the United States Highest Frequency as a Top Three Rated Sponsor Across 28 Relationship Attributes in Europe Quality of General Project Management in the United States Quality of General Project Management in Europe Quality of the Study Initiation Process in the United States Quality of the Study Initiation Process in Europe

9 xvii 5.26 p p p p p p p p p p p p p p p p p p p p p p p p. 256 Quality of the Grant Payment Process in the United States Quality of the Grant Payment Process in Europe Quality of Staff Professionalism in the United States Quality of Staff Professionalism in Europe Quality of Workstyle in the United States Quality of Workstyle in Europe Quality of Ongoing Study Support in the United States Quality of Ongoing Study Support in Europe General Project Management Evaluated in the United States Project Attributes Evaluated in the United States Project Attributes Evaluated in the United States Personnel and Work Style Evaluated in the United States Relationship Attributes Evaluated in Europe Relationship Attributes Evaluated in Europe Relationship Attributes Evaluated in Europe Relationship Attributes Evaluated in Europe Comparing Performance Quality with Category Importance in the United States Comparing Performance Quality with Category Importance in Europe Essential Attributes to Study Success in the United States Essential Attributes to Study Success in Europe Essential Attributes to Study Success in Latin America Small Company Layoff Announcements: January 2008 to January 2009 Small Company Layoff Announcements: by Percentage of Staff Reduction Small Company Layoff Announcements Cost and Savings Estimates 6.01 p p p. 269 Worldwide CRO Market: CRO Market Size and Growth Rate, Number of Clinical CROs in Europe and North America Shifting Share of Clinical Projects: Share of Industry-sponsored Projects

10 xviii 6.04 p p p p p p p p p p p p p p p p p p p p p p p p p p p p. 283 Pharmaceutical R&D Spending: Outsourced R&D Growth Outpacing Growth in Total R&D CRO Involvement Use of CRO Services: Sponsors Reasons for Outsourcing Trial Efforts Top Niche CRO Services Utilized Top Niche CRO Services Utilized: 2003 and 2005 CRO Usage in Phase I - III Projects: Percent of Clinical Projects Where CRO Played Significant Role Top Public CRO Companies: 2008 Revenues Select CRO Share Prices: Compared with Major Indices CRO Acquisitions: Total Acquisitions of Clinical CROs, Select 2006 CRO Acquisitions of Phase I Operations Select 2005 CRO Acquisitions Select 2006 CRO Acquisitions: Part 1 Select 2006 CRO Acquisitions: Part 2 Estimated Revenue Matrix: Select Public CROs Sites Rating CRO Services Very Important and Excellent Attributes More Important for CROs Than Sponsors in Europe Attributes More Important for CROs Than Sponsors in the United States CRO Performance in the United States CRO Performance in Europe Comparing CRO Performance Quality with Category Importance in the United States Comparing CRO Performance Quality with Category Importance in Europe Top CROs in the United States Highest Frequency as a Top Three Rated CRO in the United States Across 29 Relationship Attributes CRO Project Management in the United States CRO Professionalism and Work Style in the United States CRO Project Initiation and Grant Payment in the United States CRO Ongoing Study Conduct in the United States CRO Project Management in Europe

11 xix 6.32 p p p p p p p p p p p. 288 CRO Professionalism and Work Style in Europe CRO Project Initiation and Grant Payment in Europe CRO Ongoing Study Conduct in Europe CRO Performance in the United States CRO Performance in Europe Top Rated CROs in the United States: Select Project Attributes SMO Market Size: Worldwide Total Sales of SMO Services, SMOs in Clinical Trials: Reported Annual Growth in Clinical Trials Conducted by SMOs Number of SMOs: Worldwide Totals by Region, 2006 SMO Company Size: Distribution of SMOs by Number of Investigators SMO Company Size: Distribution of SMOs by Number of Sites 7.01 p p p p p p p p p p p p p p p p p. 306 Pharmaceutical Outsourcing Penetration Outsourcing Expenditure: Percentage of R&D Expenditure Outsourced Trial Outsourcing Distribution: Outsourced Trials by Provider Type, 2006 Biotech Infrastructure Expenditure: Spend on Technology, 2005 Summary of Outsourcing Department Functions Distribution of Services Provided by Outsourcing Departments Top Services Provided by Outsourcing Departments Primary Department Responsibilities Primary Department Responsibilities, 2003 and 2005 Top Regions Handled by Outsourcing Departments Highest Degree Attained by Outsourcing Department Personnel Outsourcing Department Reporting Structure Outsourcing Department Staffing Profile Changes in Outsourcing Department Headcount: During Previous Months Location of Outsourcing Department Personnel Staff Workload How Department is Initially Engaged

12 xx 7.18 p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p. 321 Top Three Department Responsibilities Criteria Used to Measure Outsourcing Department Effectiveness Department Impact on Clinical Projects Last Year Impact on Clinical Projects: 2003 and 2005 Frequency of Preparing Justification Ideal Metrics Departments are Looking to Achieve Ideal Metrics Comparisons: 2003 and 2005 Types of Contracts Responsible for: Top Factors Rated Important when Selecting a Vendor Importance of Vendor: Selection Criteria Full-service and Niche Vendor: Selection Criteria Outsourcing Strategies Pursued Contract Pricing Structures Financial Incentives Utilized Financial Penalties Utilized Top Project Payment Schedule Structures Project Payment Schedule: Structures Utilized CRO Performance Metrics Gathered Top Methods of Communication Methods of Communication Utilized Total Active U.S. IRBs OHRP-registered IRBs IRBs by Location: States with the Highest Number of Active IRBs EDC Solutions: Estimated Market Size, What is the Percentage of Trials at Your Site That Uses EDC? In What Year Were You First Required to Use EDC? How Many Companies Have Trained You on EDC? What Type of EDC Have You Used at Your Site? What Type of Company Has Trained You on EDC? Has the Effectiveness of Your EDC Training Over the Course of Your Career: Paper vs. EDC Cost Comparison

13 xxi 7.49 p p p p p p p p p p p p p p p p p. 330 Clinical Trial Laboratory Services: Total Sales, Clinical Trial Laboratory Services Market Share: Total Market = $1.6 Billion in 2005 Which Statement Best Describes the Type of Electronic Medical Record That You use? Estimated EHR Market Growth: EHR Uptake by Practice Size Top Five Benefits of EHR Top Five Barriers to Implementing EHR Patient Experience with New Medical Technologies Select EHR Providers Molecular Imaging Market: Various Techniques Molecular Imaging Market: Estimated Total Sales E-Diaries Market Estimate E-Diaries Uptake Estimate Technologies to Capture Clinical E-Diary Data: Phases I-III Compliance: Paper vs. E-Diaries Increased Compliance=Increased Quality of Results=Easier Trial Conduct E-Diaries Major Players 8.01 p p p p p p p p p p p. 345 Clinical Investigators: Number of Investigators Submitting INDs Clinical Investigators: U.S. vs. Non-U.S. Investigators Submitting INDs New Studies and New Investigators: All U.S. INDs New Studies and New Investigators: All U.S. Investigators New Studies and New Investigators: Non-U.S. Investigators First-time Investigators: First-time Investigators by Origin, Investigators Filing One Form 1572 Only Profile of Investigators Filing FDA-1572 Physicians Participating in Clinical Trials: Percentage of Surveyed Physicians with Clinical Trial Experience Number of Trials Participated in

14 xxii 8.12 p p p p p p p p p p p p p p p p p p p p p p p p p p. 358 Physician Inclination to Participate in Another Trial Why or Why Not Participate: Never Participated Why or Why Not Participate Again: Have Participated Referring Patients into Alternate Investigator's Clinical Trials Referring Patients into Alternate Investigator's Clinical Trials: Prior vs. Non-prior Reasons Physicians Don t Refer Patients into Trials: All Reasons Physicians Don t Refer Patients into Trials: Prior Reasons Physicians Don t Refer Patients into Trials: Non-prior What Would Increase Level of Comfort to Refer Patients: Prior What Would Increase Level of Comfort to Refer Patients: Non-prior R&D Personnel Number of People Employed in Health Care: Clinical Research Personnel: Distribution of Personnel by Specialty, 2006 U.S. Clinical Research Professionals: Total Number of Clinical Researchers by Employment Type U.S. Investigator Profile: Most Are Full-time Researchers European Investigator Profile: Most Are Part-time Researchers Latin American Investigator Profile: Most Are Part-time Researchers Aging Investigators: NIH Traditional Grant Recipients by Age, Medical School Graduates by Race and Ethnicity: European Study Coordinators: Percentage of Sites Employing a Study Coordinator Investigator Productivity: Number of Studies Conducted per Investigator Comparing Productivity: Average Number of Industry-sponsored Trials Conducted per Position Comparing Productivity: Average Number of Industry-sponsored Trials Conducted per Position Full-time Coordinators: Distribution of Sites by Number of Full-time CRCs CRC Productivity: 2001 vs Distribution of Full-time Coordinators

15 xxiii 8.38 p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p. 373 Distribution of Part-time Coordinators Patient Recruitment Specialist Distribution Patient Recruitment Specialists A Need for More Clinical Investigator Training Primary Training Sources for Investigators Industry Grants per Trial: Selecting Countries for Multinational Trials: Key Criteria Used by Sponsors Investigative Site Operating Concerns: Most Frequent Responses What Is the Biggest Challenge You Face Today? Investigative Site Perceptions of Changes in Profit per Grant Sponsor and CRO Payment Tardiness: Site Perceptions of Changes in Payment Timeliness Reported Operating Margins: Average Across Investigative Sites Real Fees per Patient: Average Fees Paid U.S. vs. E.U. Average Site Expenditures Typical Investigative Site Revenue Allocation: 2007 Grants vs. Volume Types of Trials Paying Subjects Phases of Trials Paying Subjects Payment Based on Size of Trial Was Payment Prorated? Institutional Policy Regarding Payment Factors Influencing Decision Not to Pay Subjects Factors Influencing Amounts of Payments Offered Would Recruitment Have Been Easier with Payment? Recruitment Would Have Been Easier if They Had Offered More Payment Biggest Challenges to Conducting Clinical Trials in Latin America Study Conduct in Latin America Training in Latin America Who Provided Training? Latin America Meeting Type Preference

16 xxiv 8.68 p p p p p p p p p p p p p p p p. 381 Live Meetings Most Valuable at Meetings Least Valuable at Meetings Do You Typically Attend the Study-Start up Meeting? Protocol Training Preferred Learning Methods Remote Meetings: Positives Remote Meetings: Negatives Who Attends Investigator Meetings? Novel Approaches to Investigator Meetings Percent Receiving Formal Training in Clinical Trials: Based on Number of Trials Participated in What Type of Training Did You Receive? Was the Training Adequate? What Factor Would Have the Most Impact on Your Decision to Leave Your Current job? What Other Type of Training do You Feel is Essential to Do Your Job? What is the Top Factor That Contributes to Delays in the Conduct of Your Trials at Your Site? 9.01 p p p p p p p p p p p p. 397 Average Number of Evaluable Patients per NDA 2003 Clinical Trial Participation by Country Frequency of Online Health Searches in the Last Month How U.S. Patients Learn About Trials Individuals Using the Internet to Find Health-related Information World Internet Penetration Rates Types of Online Health Information Portals Used by Patients Trial Information Distribution: Helping Patients Understand Research Risk May Impact Participation Ways in Which Patients Supplement Their Doctor s Efforts Race/Ethnicity Volunteer Education Levels What Language do You Speak at Home?

17 xxv 9.13 p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p. 413 How Many Studies Participated in Most Frequent Illness Addressed How Did You First Contact the Study Center? Promptness of Study Staff Reply How Long Was the Study? How Many Visits Were Required for the Study? Awareness of Clinical Trials Prior to Learning of the Study Factors Impacting Study Participation Factors Reducing Volunteer Willingness to Participate Deciding to Participate in Trials Study Participation Concerns Physicians Ability to Guide Patients to Additional Information on Trials Compensation for Participation Patient Support Type of Support Received Initial Visit Informed Consent Did You Read the Informed Consent Form? Who Reviewed the Informed Consent Form with You? How Well Did You Understand the Informed Consent Form? I Understood That I may Receive a Placebo (Sugar Pill) Instead of the Investigational Medicine Understanding Study Expectations Understanding Study Expectations Understanding Study Expectations Volunteer Satisfaction With Efficacy of Care Dropping Out of the Study Reasons for Dropping out Volunteer Satisfaction with Quality of Care in Trials Volunteer Experiences Family Referrals Factors Impacting Participation in Pediatric Studies Projected Change in U.S. Population Mix:

18 xxvi 9.45 p p p p p p p p p p p p p p p p p p p p p p p p p p. 426 Minority Participation in NIH Phase III Trials: Domestic Trials Funded by NIH, Subgroup Representation in Clinical Trials Minority Participation in Clinical Trials Enrollment by Sex: Protocols Exclusive to Sex: How Interested are You in the Results of New Health Research Studies? Which of the Following Reasons Did You Have for Not Participating? How Did You Feel About Participating in this Health Research Study? Opinions on Privacy Protection in Medical Studies What Are the Main Reasons for Not Wanting to Give Advance General Consent or to Have Your Information Used Without a Consent? I Trust my Health Care Providers to Protect the Privacy of my Personal Medical Records Health Researchers can Generally be Trusted to Protect the Privacy of Medical Records The Privacy of Personal Medical Records is Not Well Protected Today by Laws and Practices I Still Worry About a Professional Health Researcher Seeing my Medical Records Cancer Incidence by Race/ethnicity and Sex, 2004 Prostate Cancer by Race/ethnicity, 2004 Breast Cancer by Race/ethnicity, 2004 Cervical Cancer by Race/ethnicity, 2004 HIV/AIDS Distribution by Race/ethnicity, Pancreatic Cancer Incidence by Race/ethnicity and Sex, 2004 Lung Cancer by Race/ethnicity and Sex, 2004 Diabetes Incidence by Race/ethnicity, U.S. Population Without Health Insurance: 2004 and 2007 U.S. Population Without Health Insurance by Income Level, 2004 and 2007 Source of Prescription Drugs Expenditures: Top Therapeutic Categories Contributing to Drug Expenditures: 2006

19 xxvii 9.71 p p p. 428 Health Care Expenditure as a Percent of Income: 2004 Health Care Expenditure by Age Group: 2004 The Five Most Costly Conditions in the U.S.: 1997 and p p p p p p p p p p p p p p p p p p p p p p p p p p p. 451 Total NDA Submissions and Approvals, Total NDA Approvals, Total NME Approvals, NMEs and Domestic R&D Expenditure: NDAs Approved by Review Status NDA Approvals by Chemical Type: NDA Approvals by Chemical Type FDA Orphan Drug Approvals FDA Orphan Drug Designations FDA Orphan Drug Designations by Therapeutic Area, 2005 FDA Orphan Drug Designations: Designations Granted by Therapeutic Area, Combination Products Assignments by Center FY2004-FY2007 Combination Products Under Review: FY2004-FY2007 New Biologic Approvals: Oncology NCE Launches per Year: NDA Approvals and Post-marketing Commitments: Status of Open Post-marketing Commitments: As of 2/4/09 Percent of NCEs/NASs First Launched in U.S.: by PDUFA Cohort Total Original IND Submissions: Commercial and Non-commercial IND Submissions: Original Commercial INDs by Year Generic Submissions and Approvals: Generic Drug Tentative Approvals: Generic Approval Times: Median Time to Approval, ectd Submissions: Submissions as of Date First Action by FDA: All NDAs, Fiscal Year Cohorts First Action by FDA: Priority NDAs, Fiscal Year Cohorts First Action by FDA: Standard NDAs, Fiscal Year Cohorts

20 xxviii p p p p p p p p p p p p p p p p p p p p p p p p p. 463 FDA Fast Track Designations: Outcome of Fast Track Applications, FDA Fast Track Designations Granted by Therapeutic Area Accelerated NDA Review: NDAs Receiving Priority or Orphan Status Accelerated NME Review: NMEs Receiving Priority or Orphan Status, by Year Priority Review Status: Priority Review Designations by Therapeutic Area, 2004 Priority NDA/BLA Approval Rates: Percentage Approved per Six-month Interval, by Year of Submission Standard NDA/BLA Approval Rates: Percentage Approved per sixmonth Interval, by Year of Submission Average Exclusivity for Newly Launched Drugs IDE Submissions: Total Submissions Received by Filing Type, IDE Decision Times: Average Time from Filing to Decision, HDE Applications: Total Submissions Received by Filing Type, (k) Classifications: Submission Outcomes, FY2002-FY (k) Submissions: Total Submissions Received, PMA Filings: Submission Outcomes, PMA Applications: Total Submissions Received by Filing Type, FDA Site Inspections: Site Inspections by Target, FDA Site Inspections: Site Inspections Worldwide by Outcome, FDA Site Inspections: Most Common Citations by Type, FDA Site Inspections: Common Citations by Type, FDA Site Inspections: Percent Site Inspections for Investigator Conduct, Resulting Actions from FDA Inspections: Data by Country, Resulting Actions from FDA Inspections: Data by Country, Resulting Actions from FDA Inspections: Data by Country, International Clinical Investigator Inspections: FY Location of International Inspections: (n=727)

21 xxix p p p p p p p p p p p. 469 Investigator Disqualifications: Number of Disqualifications from CDER/CBER, Responsibility for Compliance Failure: Who Investigators Believe Is Responsible for Compliance Failure FDA Public Health Advisories: Safety Warnings Issued for Approved Drugs, 2004 FDA Public Health Advisories: Safety Warnings Issued for Approved Drugs, 2005 FDA Public Health Advisories: Safety Warnings Issued for Approved Drugs, 2006 Approved Drugs Withdrawn from Market: Adverse Event Reporting FDA Biomonitoring Inspections with Site Visits: FY2000-FY2005 Process for FDA Review of Human Drug Applications: Total Costs PDUFA Fees Collected Top 10 Drug Classes Impacted by Medicare Part D p p p p p p p p p p p p p p p p. 493 Ongoing Clinical Trials: Estimated Phase I Trials, 2008 Ongoing Clinical Trials: Estimated Phase II Trials, 2008 Ongoing Clinical Trials: Estimated Phase III Trials, 2008 Ongoing Clinical Trials: Estimated Phase IV Trials, 2008 World R&D Market Share: PhRMA-member Companies Growth of Foreign-based Studies Clinical Trial Initiations: Based on FDA-1572, Sources of 1572 Filings: Origin of Studies Initiated: Clinical Trials by Origin: All U.S. INDs Site Locations by Number of Countries Submitting 1572s Selecting Countries for Multinational Trials: Key Criteria Used by Sponsors 1572s by Region: s in Established Regions: s Outside North America: s in Ascending Markets: As a Percentage of All 1572 Filings, by Year

22 xxx p p p p p p p p p p p p p p p p p p p p p p p p p p p s by Foreign Country: BRIC Countries, s by Foreign Country: BRIC Plus MK Countries, s by Ascending Region s by Foreign Country: Asia-Pacific Countries Part I, s by Region: Asia-Pacific Countries Part II, s by Top Five European Countries: U.S. INDs from Select Latin American Countries: Canadian Regulatory Review: NDSs Submitted and Approved, Canadian Regulatory Review: NASs Submitted and Approved, Canadian Regulatory Review: CTAs Submitted, Canadian Regulatory Review: CTAs Submitted by Phase, Canadian Regulatory Review: Priority Review Submissions Approved, Canadian Regulatory Review: Median Time to Approval for Priority and Standard NDSs, Canadian Regulatory Review: Median Time to Approval for Priority and Standard NASs, NIH Grants to Canada Large Market Potential in Asia-Pacific Japanese NDA Approvals: FY Japanese Regulatory Review: Priority NDAs Approved Japanese Regulatory Review: NCEs Approved, New Drug Approvals in Japan: Conditional vs. Non-conditional New Drug Approvals in Japan: Conditional vs. Non-conditional Clinical Development Period Japanese Bridging Study Consultations Japanese Bridging Study Approvals Japanese Regulatory Review: Initial CTNs Submitted for new Chemical Entities (NCEs), Clinical Trial Notifications for Drugs: Japan Japanese vs. Overseas Approval: Years From Overseas Approval to Japanese Approval, new Drugs Approved in 2005 Average Time From Initial Global Launch to Start of Marketing

23 xxxi p p p p p p p p p p p p p p p p p p p p p p p p p p p p. 521 Japanese Approvals Accelerating: Time from NDA to Approval by Year of Submission, E Japanese Regulatory Review: New Medical Devices Approved, FY Japanese Regulatory Review: Generic Approvals, FY Japanese CROs: Number of Employees Japanese CROs: Employee Breakdown by Services Japanese CROs: Breakdown of Outsourced Projects by Services Japanese CROs: Employee Breakdown by Services NIH Grants to Japan Korean Trials Korean Trials: Drugs vs. Biologics Korean Trials: Biologic Trials, Clinical Trials in Taiwan: Local vs. Multinational Clinical Trials in Taiwan by Phase Singapore Regulatory Review: New Drug Approvals, Singapore Regulatory Review: Clinical Trials Initiated by Phase, Singapore Regulatory Review: Clinical Trials Initiated, 2007 Singapore Biomedical Sciences Employment Growth Number of Clinical Trials in Hong Kong Australian Trials by Phase: FY2004/2005 Australian Regulatory Review: Estimated Category 1 Applications, 2003/ /2008 Australian Regulatory Review: Orphan Drug Designations Granted NIH Grants to Australia EU Regulatory Review: Outcomes for Centralized MAAs, EU Regulatory Review: MAAs Submitted Under the Centralized Procedure, EU Regulatory Review: Mutual Recognition Applications, EU Regulatory Review: Orphan Medical Product Designations, EU Regulatory Review: Orphan Designation Review Time, EU Regulatory Review: Orphan Designations,

24 xxxii p p p p p p p p p p p p p p p p p p p p p p p p p p p p p. 535 EU Regulatory Review: Mean Centralized MAA Review Times, NIH Grants to EU Members: Clinical Trials Approved in Russia Percentage of Clinical Trials Conducted by CROs in Russia Russian Patients Enrolled in Clinical Trials Originating Country of International Clinical Trials in Russia Active Phase II-IV Sites: East Europe/Russia Registered Trials: Emerging Cities Major Barriers to Expansion of the Polish Clinical Trials Market Indian Investigators Filing 1572s NIH Grants to India Projected Indian Pharmaceutical Market: The Indian Clinical Trials Market: an Overview Healthcare Coverage in India by Source Indian Pharmaceutical Market by Therapeutic Area Latin American Demographics Population Distribution by Age: World and Select Latin American Countries Latin American Populations: Five Largest Countries Argentine Clinical Trial Protocols Approved: Trial Sponsors in Argentina: Argentine Trials by Phase: South African Healthcare Market Estimated Pharmaceutical Use in China: NIH Grants to Foreign Countries: Grants to All Research Interests, International NIH Grant Recipients: Top Recipients by Country, 2008 AT Kearney Overall Country Attractiveness Index for Clinical Trials International Regulatory Bodies: Selected Regulatory Bodies and Filing Names Regulatory Bodies for Selected EU Countries Drug Spending as a Percentage of Total Health Spending:

25 xxxiii p p p. 537 Percent of GDP Spent on Health Care: Select Countries, Source of Prescription Drugs Expenditures: Public vs. Private Spend on Healthcare: Asia-Pacific