2013 Clinical Trials Data Library

Transcription

1 CHAPTER ONE The Drug DevelOPmENT PiPEliNE Drugs in Worldwide Clinical Development New Drug Approvals Distribution of Global Drug Pipeline by Research Phase Worldwide Active R&D Projects in Development Distribution of Active Projects in Clinical Phases Only Distribution of Global Pipeline by Molecule Type Number of Companies with Active Clinical Projects Worldwide Top Five Largest Pharmaceutical Company Pipelines Most Active Clinical Pipelines Drugs in Preclinical Testing New Clinical Trials Started Worldwide Clinical Trial Initiations Worldwide Clinical Trials Volume Percent of Clinical Trials Initiated Outside the US Distribution of Active Clinical Trials Active Phase I Clinical Trials Worldwide Active Phase ii Clinical Trials Worldwide Active Phase iii Clinical Trials Worldwide Active Phase iv Clinical Trials Worldwide Distribution of Global R&D Projects by Therapeutic Area Drugs in Clinical Development by Therapeutic Area Top Five Most Active Therapeutic Areas in Clinical Testing Therapeutic Area Growth Global Compounds in R&D by Therapeutic Area: Top Five Global Compounds in R&D by Therapeutic Area: Next Five Worldwide R&D Pipeline by Therapeutic Area Worldwide R&D Pipeline by Therapeutic Area Worldwide R&D Pipeline by Therapeutic Area Worldwide R&D Pipeline by Therapeutic Area Projects in Development by Therapeutic Area Projects in Development by Therapeutic Area Projects in Development by Therapeutic Area Oncology Drugs in the R&D Pipeline Number of Vaccine Drugs in Development An Expanding Vaccine Pipeline Primarily Phase I and ii Growth in the Vaccines Development Pipeline First-in-Class Medicines in Development Drug Approvals for Rare Diseases Need for New Treatments for Alzheimer s Disease Need for Treatments: Parkinson s Disease Top Five Fastest Growing Therapeutic Areas by Prescription Drug Sales

2 CHAPTER TWO Drug Development PerfORmance Cycle Time Drug Development Duration Clinical Approval Times for Drugs and Biopharmaceuticals Clinical and Approval Times Cycle Time Acceleration Targets Success Rates Phase Transition Probabilities for All Drugs Success Rate Variation by Molecule Size NCE Approval Success Rates by Therapeutic Class Success Rates by Therapeutic Area and Phase Success Rates in Oncology Incidence of Project Cancellations Estimated Value of Cancellations Traditional Clinical Development Scope, Purpose and Duration Traditional Development Duration Average Cycle Time from Pre-study Visit to Site Initiation Are Global Trials Really Faster? Total Approval Phase for Drugs with NDAs or BLAs Submitted FY Total Approval Phase for Drugs with NDAs or BLAs Submitted FY

3 CHAPTER THREE Drug Development EConomics Global R&D Spending R&D Spending Biopharmaceutical Companies Invest in R&D Annual Growth in R&D Spending Annual Growth in R&D Spending Benchmark R&D Spend as a Percentage of Sales R&D Spending as a Percent of Sales by Sector Estimated Worldwide R&D Spending as a Percent of Sales Benchmark R&D Spending and Annual Growth Global R&D Spending by Clinical Trial Phase Global R&D Spending by Phase Direct and Capitalized Cost of Developing a Single Drug Total Global Spending on Clinical Development Clinical Services Outsourcing Reported Percentage of Annual R&D Budget Spent on Outsourcing Growth in Global Phase I-iii Clinical Trial Grant Spending Total Spending on Clinical Trial Grants Total Clinical Trial Grant Spending Clinical Trial Grant Sources for Academic Centers Industry Spending on Clinical Trial Grants by Phase (2008) Mean Cost Per Patient by Phase Annual Growth in Per Patient Cost Mean Cost Per Patient by Therapeutic Area Across Phases I-iii Screen Failure Costs as a Percentage of Total Cost per Patient Mean Per Patient Costs Relative to North American Rates Average Number of Patient Payments by Annual Recruitment Volume Reported Time Required for Sites to Process One Payment Reported Number of Administrative Steps per Patient Payment Mean Patient Reimbursement Per Visit Mean Patient Reimbursement Per Visit by Therapeutic Area Across Phases ii & iii Industry Spend on KOLs Average Hourly Rates

4 CHAPTER FOUR Clinical ResEARCH PARTners Contract Clinical Outsourcing Total Global Market for Contract R&D Services Clinical Trial Laboratory Services Market Size Global Market for Contract Preclinical and Clinical Services Clinical Services Outsourcing The Integral Role of CRO Partners: Worldwide R&D Capacity Percentage of Budget Dollars Spent on Outsourcing Pharma Industry Job Cuts: U.S. Top Pharma Staffing Changes Pharma Executive Compensation Top CROs by Worldwide Employee Size Incidence of Site Management Responsibilities Outsourced to CROs Site Management Responsibilities Outsourced by Company Size Site Ratings of Sponsor and CROs Relationship Attributes Site Ratings of Sponsor and CRO Study Conduct Support Attributes Number of Sponsor FTEs Assigned per 100 Dedicated CRO FTEs Major CRO Proclivity to Acquire Companies Most Active Major CROs Profile--inVentiv Health Comparing Major CRO M&A Activity Over Two Time Periods Volunteer Consent Rates When Asked by Physician/PI to Participate Screen Failure Costs as a Percentage of Total Cost per Patient Incidence of Pre-study Visits Performed by Sponsors Impact of Pre-study Visits Industry Spend on KOLs Average Hourly Rates Average Number of Pages per Investigator Brochure Parexel Annual Revenue Parexel Annual Revenue Growth Rates Distribution of Fiscal 2012 Revenue Evolving Parexel Scale and Infrastructure Principal Investigator Disparities Sponsor Reports of Minority Investigator Performance Compared to that of White Investigators Comparing Site Ratings of Overall Relationship Quality with CROs Distribution of Contract Clinical Services Market Segments The Global Investigative Site Landscape 30 Years of Expanding Services and Outsourcing Models High Global Demand for CRO Services Leading CROs

5 CHAPTER FOUR Clinical ResEARCH PARTners Proportion of Top 30 Pharma Companies in at least One FSP/ Multi-FSP/Integrated Alliance Expected Impact from Strategic Outsourcing Relationships Sponsor Participation in Open Innovation Initiatives CHORUS Model Estimated Time and Cost Improvements Profile of the Structural Genomics Consortium Investigative Site Landscape Active Unique Investigators Filing Form 1572s World Wide Proportion of Novice Investigators Conducting Clinical Trials Global Distribution of 1572 Filings Distribution of Industry-Funded Clinical Trials in the U.S. Global Market Share of Active Clinical Trials by Investigative Site Setting Comparing Network Size Geographic Focus and Scope Largest Site Management Organizations in 2000 Number of Clinical Grants Awarded Distribution of Annual Study Volume per Investigator Top Investigative Site Operating Concerns Economic Outlook by Years of Site Experience Conducting Clinical Trials Rising Scope and Declining Size of Clinical Trials Site Reported Cancellations Site Reported Recovery of Start-Up Costs Associated with Cancellations Global Investigative Site Staffing Total FTE Employees per Investigative Site Mean Number of Employees by Staff Type (Full and Part Time) Mean Number of Employees by Staff Type by Region (Full and Part Time) Global Investigative Site Mean Revenue and Profitability Investigative Site Expenses and Profit Type of Accounting Method Used by Investigative Sites Wide Differences in Site Payable and Receivable Cycles Percentage of Clinical Research Revenue Owed That was Written off as Bad Debt in 2011 The Increasing Proportion of Low Volume Investigators Investigator Turnover Rates by Region Investigator Dropout Rates Investigator Continuity and Decay Rates Rolling Change in Total Active Unique Investigators Filing Form 1572s Investigative Site Outlook 2011 Investigator Dropout Rates Global Investigative Site Mean Revenue and Profitability Distribution of Total Investigative Site Expenses

6 CHAPTER FOUR Clinical ResEARCH PARTners Perceived Economic Conditions Profit Expectations for 2012 Sponsor Payment Promptness Revenue and Profitability by Investigative Site Size Profile: Small Sites Profile: Mid-sized Sites Profile: Large Sites Growth in Clinical Grant Revenue by Investigative Site Type The Investigative Site Landscape in Western Europe Allocation of Clinical Trial Grant Expenses Investigative Site Personnel Size Distribution of Investigators by Site Type Perception of 2012 Economic Conditions Compared to 2011 Average Clinical Trial Grant Size Traditional and Non-Traditional Recruitment Tactics Used Typical Site Enrollment Performance Enrollment Achievement by All Sites in a Given Region Top Factors Most Often Causing Clinical Trial Delays Clinical Research Coordinators Years in Current Position Comparison to Previous Years Years Clinical Research Experience Comparison to Previous Years Years in Current Position by Years of Clinical Research Experience Clinical Research Coordinator Workload Clinical Research Coordinator Salaries Clinical Research Coordinator Salaries Distribution of Full-Time Clinical Research Coordinators Distribution of Part-Time Clinical Research Coordinators Summary of Significant Differences For-Profit vs Not-for-Profit Highest Level of Education Completed Highest Level of Education Completed Certification Certification - Organization Year Certified Ongoing Training Primary Training Sources PI and CRC Ratings of GCP Training Primary Payer of CE Credits Distribution of Full-Time Clinical Research Coordinators Distribution of Part-Time Clinical Research Coordinators Study Coordinators: Number of Years in Current Position Years in Clinical Research Study Coordinator Experience

7 CHAPTER FOUR Clinical ResEARCH PARTners Length of Employment at Current Site Study Coordinator Employment Continuity Annual Full-Time CRC Turnover Rate Position CRCs Most Aspire to Advance Into Study Coordinator Base Salary Supplemental Income Average Supplemental Income Base Salary Increase Within Past Year Average % Base Salary Increase Number of Studies Personally Overseeing Number of Patients Personally Overseeing Number of Hours Worked Per Week Responsibility Distribution Activity Distribution Change in Level of Responsibilities Over Past Year Change in CRC Responsibilities Over Past Year Perception: Is Salary Commensurate with Additional Workload? Most Common Obstacles in Completing Tasks Top Perceived CRC Career Benefits Top Perceived CRC Career Challenges Study Coordinator Distribution by Site Type PhRMA Personnel Various Clinical Trial Activities CRA Time Allocation by Region Regional Variation in CRA Quality-of-Life Assessments Patients/Study Volunteers Average Number of Volunteers Enrolled per Clinical Trial Factors Contributing Most to Delays in Enrolling the First Patient Study Start-Up Cycle Time by Site Type Study Start-Up Cycle Time by Region Study Volunteer Attrition Rates Reasons Patients Seek Clinical Trials Information Methods Used to Search for Clinical Trials Internet Resources Most Used by Patients for Clinical Trials Information Preferred Method to Contact Research Centers to Participate in a Clinical Trial Participation in a Clinical Trial Consider Participating in a Clinical Trial Again Resources Used to Learn About Participating in Clinical Trials Did You Seek Assistance in Deciding to Participate in a Clinical Trial Individual Involved in the Decision-Making Process Evaluation of the Informed Consent Process Before the Start of the Clinical Trial

8 CHAPTER FOUR Clinical ResEARCH PARTners Did You Feel that You Understood the Benefits and Risks of Participating in a Clinical Trial? Volunteer Ratings of Research Staff Who Conducted the Clinical Trial Study Participant Concerns Preference for Follow-up on Clinical Trials How Many Studies Have You Participated In? Most Frequent Illness Addressed? How Did You First Contact the Study Center? How Much Time Did it Take Before the Study Staff First Contacted You? How Long Was The Study? How Many Visits Were Required for the Study? How Aware Were You About Clinical Trials as a Treatment Option Prior to Learning About this Study? Factors Impacting Volunteer Willingness to Participate Factors Reducing Volunteer Willingness to Participate Who Helped You Make the Decision to Participate? Study Participation Concerns How Knowledgeable Was Your Physician About Where You Could Find More Information About Active Clinical Trials? Were You Compensated for Your Participation in the Study? Did You Receive Any Support that Assisted You in Participating? Type of Support Received? Whom Did You Initially Meet With On Your First Visit? Did You Receive an Informed Consent Form Before Beginning the Study? 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 Was Medical Care Helpful During the Trial? Dropping Out of the Study Reasons for Dropping Out How Would You Rate the Overall Quality of Care Received During the Study? Would You Participate in a Clinical Trial Again? Would You Recommend that a Member of Your Family or Friend Participate in a Clinical Study? Distribution of Time Spent Blogging Per Week 2011 Internet Usage Statistics Blogger Demographics

9 CHAPTER FOUR Clinical ResEARCH PARTners Clinical Trial Information Seekers: Main Motivation Health Seekers Areas of Interest Profile of Six Million Clinical Trial Information Seekers Study Volunteer Disparities in Clinical Research Patient Perceptions of Clinical Research Safety by Race and Ethnicity Patient Concentration by Physician Race and Ethnicity Patient-reported Top Sources of Clinical Trial Information Growth of Routine Usage of Social Networks by Adult Internet Users Patient Organizations Funding Clinical Research Distribution of Medical Apps on Mobile Devices

10 CHAPTER FIVE Clinical research PRACTICEs Protocol Design Protocol Complexity and Execution Burden Complexity and Work Burden by Phase Impact on Clinical Trial Performance Protocol Complexity Impact on Cycle Time Growth in Protocol Complexity and Work Burden by Phase How Important is Protocol Design to Your Decision to Participate in a Clinical Trial? Phase II and III Study Execution 2012 Distribution of Protocol Procedures The Impact of Complexity on Study Performance Amendment Prevalence Amendment Prevalence by TA Avoiding Amendments Amendment Timing Procedure Support of Endpoints Distribution of Procedures by CSR/Analysis Plan Classifications Distribution of, and Total, Direct Cost per Classified Protocol Procedures Distribution and Cost of Procedures by Endpoint Classification and Phase Relationship Management and Effectiveness Average 2011 Rating of Relationship Quality for a Typical Sponsor Sponsor Rating of Overall Relationship Quality Regional Comparison--Average Sponsor Ratings Average Sponsor Ratings by Site Type Average Sponsor Ratings by Years of Experience Company Ratings of Relationship Quality Company Ratings of Relationship Quality Frequency of Attributes in Top 3 Essential Attributes to Study Success The Top Sponsors by Essential Attributes Evaluating Sponsor Performance Evaluating Sponsor Performance Comparing Performance Quality to Category Importance Comparing Attribute Importance to Sponsor Performance--Gaps Quality of Staff Professionalism Quality of Workstyle Quality of General Project Management Quality of Study Initiation Process Quality of Ongoing Study Conduct Quality of Grant Payment Process Average 2011 Relationship Quality Rating for the Typical CRO

11 CHAPTER FIVE Clinical research PRACTICEs Benchmark Proportion of Sites Rating CRO Relationship Quality Regional Comparison of Average CRO Ratings Average CRO Ratings by Site Type Average CRO Ratings by Years of Experience The Top Rated CROs Site Ratings by Experience and Setting Comparing Performance Quality to Category Importance Comparing Attribute Importance to CRO Performance--Gaps Quality of Staff Professionalism Quality of Workstyle Quality of General Project Management Quality of Study Initiation Process Quality of Ongoing Study Conduct Quality of Grant Payment Process Sponsors Engaging More Sites to Each Enroll Fewer Patients Investigative Site Enrollment Performance CL0513/CL0513_060. png Number of Countries in which Sponsors are Placing Clinical Trials Key Performance Metrics For Investigative Sites by Region Trends in Oncology Trial Protocol Complexity Days Spent On Site Each Month by Study Monitors Prevalence of Academic Research Faculty Relationships with Industry Comparing Site Ratings of Overall Relationship Quality with CROs Sponsors Receiving Top Relationship Ratings from their Sites Site Assessment of Relationship Attribute Importance and of Sponsor Ability to Provide Them Gaps Between Relationship Attribute Importance and Excellence Ratings of Sponsor Ability to Provide Them Individual Relationship Attributes Rated the Highest Individual Relationship Attributes Rated the Lowest Sites Rate Each Company s Overall Reputation as a Sponsor of Clinical Research Patient Recruitment Distribution of Global Development Spending, Trial Volume and Patient Enrollment Probability of Successful Investigative Site Performance Preferred Patient Recruitment Methods Aggregate Patient Recruitment Success Rates Reasons Patients Seek Online Clinical Trials Information Individuals Who Would Most Influence Your Decision to Participate Top Site Perceived Factors Contributing to Faster Cycle Times Factors Contributing Most to Delays in Enrolling the First Patient Factors That Most Often Cause Delays Factors That Could Best Prevent Future Delays

12 CHAPTER FIVE Clinical ResEARCH PRACTICES Enrollment Delays Enrollment Delays by Region Percent of Sites Extending Patient Enrollment Period Development Technology Solutions EDC Solutions Estimated EHR Market Growth Hospital System Adoption of EHRs Practicing Physician Adoption of EHR Systems Barriers to Hospital System Adoption of EHRs Top Barriers to Practicing Physician Adoption of EHRs ect Systems at Investigative Sites Top Reasons for Delay in Improving ect Compatibility at Sites Preferred EDC Training Method Top Suggestions for Ways to Improve Sponsor/CRO Help Desk Support Proportion of Companies Performing 100% Source Verification CRA-reported Days per Month Spent Visiting Sites by Region Factors Determining the Frequency of On-site Monitoring Visits Total CRA-reported Workload per Month Growth of Routine Usage of Social Networks by Adult Internet Users Distribution of Medical Apps on Mobile Devices Technology Use Among IRBs Top 10 Pharma Companies On Twitter

13 CHAPTER SIX The GlobalPharmACEuTICAl Market Global Pharmaceutical Sales Year-by-Year Growth in Global Pharmaceutical Sales Patent Expirations: Worldwide Sales At Risk 2010 Global Pharmaceutical Sales by Region Top 10 Pharma Companies in the Middle East and North Africa (MENA) Region Largest Therapeutic Areas by Global Pharmaceutical Sales Largest Therapeutic Areas by Global Pharmaceutical Sales Growth in Worldwide Prescription and OTC Sales by Therapeutic Area Growth in Worldwide Prescription and OTC Sales by Therapeutic Area Global Sales Contribution By Age of Drug 2010 U.S. Prescription Sales for the Top 10 Therapeutic Classes 2010 U.S. Prescription Sales for the Next 10 Therapeutic Classes Top 10 U.S. Prescription Products by U.S. Sales, 2011 Top 10 U.S. Prescription Products by U.S. Sales, 2011 Worldwide Prescription Drugs Sales Top 10 Companies Worldwide Prescription Drugs Sales Next 10 Companies Worldwide Prescription Drugs Sales Top 10 Companies Worldwide Prescription Drugs Sales Next 10 Companies Worldwide Market Share of Prescription Drugs Sales Top 10 Companies Worldwide Market Share of Prescription Drugs Sales Next 10 Companies U.S. Generic Market Share of Prescription Sales Top 10 Generic Companies 2012 Generic Revenues U.S. Prescriptions Filled with Generics Global Biosimilars Medicare Prescription Drug Program Select Medical Device Manufacturers MENA Market Life Expectancy

14 CHAPTER SEVEN Drug DevelopmENT Regulation Drug Development Regulation IND and NDA Submissions and Approvals Number of IND Submissions Number of INDs Submitted Each Quarter YTD Total NDA Submissions and Approvals Original NDA/BLA Submissions NDA Submissions by Filing Status BLA Submissions by Filing Status NDAs Approved in First Review Cycle NMEs/NBEs First-Cycle Review Outcomes NME Submissions by Filing Status Number of NDAs and NMEs Approved Approved NDAs and NMEs Receiving Priority Designations NMEs Approved with Postmarketing Requirements and/or REMs NME/BLA Approvals NDA Approvals New Biologic Approvals FDA Orphan Drug Approvals FDA Orphan Drug Designations FDA Orphan Drug Approvals and Designations Regulatory Review and Approval Cycle Time Cycle Time in Years from IND Approval to NDA Approval Mean NME Approvals Times Median Approval Times for Biotech Drugs and Biologics Mean EMA Processing Time for Human Medicinal Products FDA Inspection Results FDA, CDER Inspections of Sponsors and CROs Complaints Filed Against Investigators Complaints Filed Against Investigative Sites as a Percentage of Active INDs CDER Inspections of Clinical Investigators Investigator Deficiencies: Final Classification of OAI Bioresearch Monitoring Inspections Overseen by FDAs CDER Site Audit Preparedness Warning Letters Issued to Principal Investigators FDA Inspection Results Investigator Disqualifications Estimated Time to Enroll FDA-Regulated Phase iii Cancer Studies Global Distribution of FDA-Regulated Clinical Trials Rising Proportion of New and Inexperienced Investigators Complaints Received, and Inspections Performed, by the FDA for Noncompliance and Fraud Distribution of Complaints against Investigators for Noncompliance and Fraud

15 CHAPTER SEVEN Drug DevelopmENT Regulation Volume of Physician-filed INDs Investigator-Initiated Trials as a Proportion of Active INDs Tracking IND Submission Sources and Growth Rates Number of Commercial IRBs in the U.S. Annual Reported Change in Workload and Resources Required Incidence and Level of Commercial IRB Use by Institutional IRBs Technology Use Among IRBs Evaluable Patients per NDA Average Number of Pages per Investigator Brochure