CenterWatch Clinical Trials Data Library

Transcription

1 CHAPTER ONE THE DRug DEvElOPmENT PiPEliNE» Drugs in Worldwide Clinical Development» 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 Six largest Pharmaceutical Company Pipelines» most Active Clinical Pipelines» New Drug Approvals» Declining global Clinical Trial volume» Worldwide Clinical Trial initiations» Percent of Clinical Trials initiated Outside the us» Worldwide Clinical Trials volume» 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» global Compounds in R&D by Therapeutic Area» Distribution of global R&D Projects by Therapeutic Area» Drugs in Clinical Development by Therapeutic Area» Therapeutic Area growth» most Active Therapeutic Areas» Worldwide R&D Pipeline by Therapeutic Area (Anabolics Biopharmaceuticals)» Worldwide R&D Pipeline by Therapeutic Area (Bone, Cartilage, Connective Tissue System Drugs Digestive System Drugs)» Worldwide R&D Pipeline by Therapeutic Area (Drug Addiction & Abuse Drugs immunologics)» Worldwide R&D Pipeline by Therapeutic Area (motor System Drugs Wound & Burn Treatment)» Projects in Development by Therapeutic Area (Anti-cancers Formulations)» Projects in Development by Therapeutic Area (musculoskeletal Dermatologicals)» Projects in Development by Therapeutic Area (Blood & clotting miscellaneous)

2 CHAPTER TWO DRug DEvElOPmEnT PERfORmAnCE Cycle Time» Drug Development Duration: Cycle Time in Years from InD Approval to nda Approval» Clinical Approval Times for Drugs and Biopharmaceuticals» Average Clinical Development Time: mean Total Development Time in months» Clinical and Approval Times» Cycle Time Acceleration Targets: Phases II-III 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: grant Dollars lost due to Cancellations in millions» Traditional Clinical Development Scope, Purpose, and Duration» Traditional Development Duration

3 CHAPTER THREE DRug DEvEloPmEnT EConomiCs» global R&D spending» Annual growth in R&D spending» Annual growth in R&D spending (cont d)» 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» Total Clinical spending by Phase» global R&D spending by Phase» Distribution of Total global R&D spending» Direct and Capitalized Cost of Developing a single Drug» Total global spending on Clinical Development» growth in global Phase i-iii Clinical Trial grant spending» Total spending on Clinical Trial grants» Total Clinical Trial grant spending» mean Cost Per Patient by Phase» Annual growth in Per Patient Cost» Clinical Trial grant sources for Academic Centers» industry spending on Clinical Trial grants by Phase» mean Cost Per Patient by Therapeutic Area Across Phases i-iii» mean Patient Reimbursement Per visit» mean Patient Reimbursement Per visit by Therapeutic Area Across Phases ii & iii

4 CHAPTER FOUR CLINICAL RESEARCH PARTNERS Contract Clinical Outsourcing» Clinical Services Outsourcing» The Integral Role of CRO Partners: Worldwide R&D Capacity» Percentage of Budget Dollars Spent on Outsourcing» Global Market for Contract Preclinical and Clinical Services» Top CROs by Worldwide Employee Size» Incidence of Site Management Responsibilities Outsourced to CROs» Site Responsibilities Outsourced by Company Size» Site Ratings of Sponsor and CRO Relationship Attributes» Site Ratings of Sponsor and CRO Study Conduct Support Attributes» Sponsor and CRO Payment Tardiness: Site Perceptions of Changes in Payment Timeliness» Clinical Trial Laboratory Services Market Size 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 US Global Market Share of Active Clinical Trials by Investigative Site Setting» Comparing Network Size» Geographic Focus and Scope» SMOs of Yesteryear» Number of Clinical Grants Awarded» Top Investigative Site Operating Concerns» Distribution of Annual Study Volume per Investigator» 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 is Written off as Bad Debt in 2011»

5 CHAPTER FOUR CLINICAL RESEARCH PRACTICES Patients / Study Volunteers» 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 Study Participation» 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: Physician Visits and Medication Treatment» Understanding Study Expectations: Understanding the Risks» Understanding Study Expectations: Information Received Matched Actual Experience» 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?

6 CHAPTER FIVE CLINICAL RESEARCH PRACTICES Protocol Design» Rising Protocol Complexity and 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: CAGR» How Important is Protocol Design to Your Decision to Participate in a Clinical Trial? 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 (cont d)» Frequency of Attributes in Top 3: Good / Excellent Ratings» Essential Attributes to Study Success» The Top Sponsors by Essential Attributes» Evaluating Sponsor Performance: Better and Much Better Rating» Evaluating Sponsor Performance: Worse and Much Worse Rating» Comparing Performance Quality to Category Importance» Comparing Attribute Importance to Sponsor Performance - Gaps» Quality of Staff Professionalism: Sponsor» Quality of Workstyle: Sponsor» Quality of General Project Management: Sponsor» Quality of Study Initiation Process: Sponsor» Quality of Ongoing Study Conduct: Sponsor» Quality of Grant Payment Process: Sponsor» Average 2011 Relationship Quality Rating for the Typical CRO» 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

7 CHAPTER FIVE CLINICAL RESEARCH PRACTICES» Quality of Staff Professionalism: CRO» Quality of Workstyle: CRO» Quality of General Project Management: CRO» Quality of Study Initiation Process: CRO» Quality of Ongoing Study Conduct: CRO» Quality of Grant Payment Process: CRO Patient Recruitment» Distribution of Global Development Spending, Trial Volume, and Patient Enrollment» Probability of Successful Investigative Site Performance» A Typical Multi-Site Recruitment Pattern» 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» Enrollment Delays» Enrollment Delays by Region» Percent of Sites Extending Patient Enrollment Period Section Cover Slide: 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

8 CHAPTER SIX THE GlobAl PHARmACEuTICAl market» Global Pharmaceutical Sales» Year-by-Year Growth in Global Pharmaceutical Sales» 2010 Global Pharmaceutical Sales by Region» largest Therapeutic Areas by Global Pharmaceutical Sales» largest Therapeutic Areas by Global Pharmaceutical Sales (cont d)» u.s. Generic market Share of Prescription Sales» Growth in Worldwide Prescription and otc Sales by Therapeutic Area: » Growth in Worldwide Prescription and otc Sales by Therapeutic Area: (cont d)» Global Sales Contribution by Age of Drug» Annual Growth Rate of u.s. Prescription Pharmaceutical market» 2010 u.s. Prescription Sales for the Top 10 Therapeutic Classes» 2010 u.s. Prescription Sales for the Next Top 10 Therapeutic Classes» Top 12 u.s. Prescription Products by u.s. Sales, 2010» Next 13 u.s. Prescription Products by u.s. Sales, 2010» 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» Worldwide medical Device market: Projected Sales» u.s. medical Device market: Projected Sales» Select medical Device manufacturers» Generic Pharmaceutical market» Top 10 Generic Companies

9 CHAPTER SEVEN DRUG DEVELOPMENT REGULATION IND and NDA Submissions and Approvals» Number of IND Submissions» Number of INDs Submitted Each Quarter» Total NDA Submissions and Approvals» Original NDA / BLA Submissions» NDA Submissions by Filing Status» BLA Submissions by Filing Status» 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 Regulatory Review and Approval Cycle Time» Cycle Time in Years from IND Approval to NDA Approval» Mean NME Approval 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 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