Description
The cost of drug development has soared during the past ten years compelling pharmaceutical and biotechnology companies to look for new, smarter ways of conducting clinical research. Driven by mounting market pressures, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry. This industry has evolved from providing limited clinical trial services in the 1970s to a full-service industry that today encompasses the entire drug development process, including preclinical evaluations, study design, clinical trial management, data collection, biostatistical analysis, and completing product regulatory requirements.
Outsourcing is not a new concept to pharmaceutical companies; however, its use increased dramatically in the mid-1990s, and it is expected to continue to increase going forward. It is estimated by 2004 nearly 42% of all pharmaceutical drug development expenditures will be committed to outsourcing, as compared to the 4% that was outsourced in the early-1990s. Some estimate that there are currently over 1,200 organizations involved in the clinical research, including pharmaceutical and biotechnology in-house clinical research, site management organizations (SMOs), academic medical centers, private research sites, and contract research organizations (CROs).
CROs were first organized as outsourcing service companies that provided only clinical trial management. Today, many CROs have expanded their scope of services to provide comprehensive management of the complex drug trial processes for their client companies, as well as providing access to vast areas of expertise, which may not exist in the client’s internal organization. Over the past few years, CROs have received the lion’s share of outsourced clinical research revenue. In 2001, in the United States, CROs received an estimated 60% of the clinical research outsourced from pharmaceutical companies.
Typically, large CROs compete on the basis of medical and scientific expertise in specific therapeutic areas; the ability to manage large-scale trials on a global basis with strategically located facilities; by providing medical database management capabilities; providing statistical and regulatory services; the proven ability to recruit principal investigators, and patients into studies; and the ability to integrate information technology with systems to improve the efficiency of contract research. The combination of the growing trend by pharmaceutical companies to outsource a wider range of services, and the need to pass products through the testing and regulatory process in a rapid, cost-effective manner, has lead to skyrocketing growth of the CRO market. The CRO market grew from $1 billion in 1992 to more than $8 billion in 2002. CROs enrolled 7 million research subjects in 1992, and 20 million in 2001.
The efficiency of a clinical trial can be greatly compromised by the challenge of efficiently enrolling patients, securing clinical trial sites, and collecting data. Pressure to expedite clinical trials, while reducing the cost of the trials, has led to yet another new, rapidly evolving business: Site Management Organizations (SMOs). SMOs are quickly consolidating the fragmented clinical investigator market into well-managed networks of sophisticated clinical research sites. SMOs are management service companies that organize and manage multi-site clinical trials through contractual relationships with site owners, or direct ownership of the sites. Analysts estimate that the SMO industry will grow at a rate of about 43% per year over the next few years. Although SMOs represent competitors of CROs, they are also often subcontractors to them. It is estimated that as many as half of an SMO’s clients are CROs.
It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner. To accomplish this goal, pharmaceutical companies are relying on outsourcing strategies to provide the services that can bring their therapeutics to market faster.
This report explores the complexities and costs of the clinical research in the drug development process. In addition to a thorough evaluation of the market data, the report goes on to
- examine government regulations governing human trials,
- describe how and where clinical trials are conducted,
- examine the process by which investigators and patients are recruited,
- identify the trends and issues in outsourcing clinical research, and
- profile CROs, SMOs and various niche competitors in the clinical trials industry.
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
- Government Regulation of Clinical research
- New Drug Application
- New Drug Approval Times
- New Molecular Entities
- Fast Track, Priority Review and Accelerated Approval
- Clinical Trials Operations
- Organizations Conducting Clinical Trials
- Designing Clinical Trials
- Recruiting For Clinical Trials
- Recruiting Principal Investigators
- Recruiting Patients
- Participant Retention
- eRecruitment: Internet-enabled Recruitment
- Informed Consent Process
- Demographics and Clinical Trials
- Electronic Data Capture
- Competing in the Contract Research Industry
- Academic Medical Centers and Teaching Hospitals
- Contract Research Organizations
- Site Management Organizations
- Preclinical and Clinical Laboratories
- Niche Service Providers
- Contract Research Market
CHAPTER TWO: INTRODUCTION TO CLINICAL RESEARCH
- Drug Development Process
- Government Regulation of Clinical Research
- Center for Biological Evaluation and Review
- Center for Drug Evaluation and Research
- Investigational Review Board
- Preclinical Research
- In Vitro and In Vivo Testing Process
- Investigational New Drug Application
- Clinical Trials
- Phase I
- Phase IIa
- Phase IIb
- Phase III
- Phase IIIa
- Phase IV
- New Drug Application
- New Molecular Entities and Approval Times
- Fast Track, Priority Review, and Accelerated Approval
- Fast Track Approval
- Priority Review
- Accelerated Approval
- FDA Initiative to Improve Research and Review Process
- New FDA Proposal Could Add to Size and Cost of Clinical Trials
CHAPTER THREE: CLINICAL TRIALS OPERATIONS
- Conducting Clinical Trials
- Organizations Conducting Clinical Trials
- Government Sponsored Clinical Trials
- Private Sector Sponsored Clinical Trials
- Designing Clinical Trials
- Clinical Trial Components
- Protocol
- Eligibility Criteria
- Endpoints
- Randomization
- Stratification
- Blinding
- Data Collection and Management Tools
- Statistical Significance
- Trial Size
- Relative Risk
- Active Clinical Trials Worldwide
- Recruiting for Clinical Trials
- Cost of Recruiting Delays
- Recruiting Principal Investigators
- Recruiting Patients
- Factors Influencing Participation in Clinical Trials
- Participant Retention
- eRecruitment: Internet-Enabled Recruitment
- Informed Consent Process
- Demographics and Clinical Trials
- Age, Race, Ethnicity, and Gender in Clinical Trials
- Minorities and Women in Clinical Trials
- Special Need for Older and Minorities Patients in Cancer Trials
- Electronic Data Capture
- Advantages of EDC
- Adaptation of EDC Technology to Drug Development
- Attitudes Shifting to EDC
- Need for an EDC Standard
- FDA Encourages EDC Systems
- Electronic Patient Diaries
CHAPTER FOUR: COMPETING IN THE CONTRACT RESEARCH INDUSTRY
- Drug Development Costs
- Outsourcing Solutions
- Factors Driving Contract Research Strategy
- Cost Reduction Strategy
- Increasing Number of New Chemical Entities (NCEs) in Pipeline
- Time to Market Pressures
- Growing Complexity of Regulatory Requirements
- Rapid Access to Patient Recruiting
- Contract Research Competitors
- Academic Medical Centers and Teaching Hospitals
- Contract Research Organizations
- Preclinical and Clinical Laboratory Services
- Site Management Organizations
- Clinical Trials as a Business Opportunity
- Community Physicians
- e Technology Solutions
- Internet Patient/Investigator Recruiting
- Clinical Trials Packaging
- Promoting Patient Compliance
CHAPTER FIVE: CONTRACT RESEARCH MARKET
- Trends in Research and Development Spending
- Pharmaceutical Companies: R&D Spending
- Biotechnology Companies: R&D Spending
- Clinical Research Projects in Development
- The Contract Research Market
- Market Size and Shape
- The Rise and dominance of CROs
- AMC’s Fight to Regain Market Share
- SMO’s Gain Market Share
- Central Laboratories Compete for Market Share
- Niche Players
- Emerging Technologies Improving Clinical Development
CHAPTER SIX: COMPANY PROFILES
- Contract Research Organizations
- AaiPharma, Inc.
- BioReliance Corporation
- Covalent Group, Inc.
- Covance, Inc.
- Inveresk Research Group, Inc.
- Kendle International, Inc.
- MDS Pharma Services
- Omnicare, Inc.
- Parexel International Corporation
- Pharmaceutical Product Development, Inc.
- Quintiles Transnational Corporation
- SFBC International, Inc
.- Preclinical and Clinical Laboratories
- Bioanalytical Research Corporation
- Calvert Laboratories, Inc.
- CentraLabS Clinical Research
- Charles River International Laboratories, Inc.
- ClinTrials BioResearch Ltd.
- Huntingdon Life Sciences Research, Inc.
- Laboratory Corporation of America Holdings
- Financial Information
- Pacific Biometric, Inc.
- Perry Scientific, Inc.
- Quest Diagnostics
- SNBL USA, Ltd
- Site Management Organizations
- AmericasDoctor, Inc.
- DaVita Clinical Research
- nTouch Research Corporation
- PharmaTrials, Inc.
- Radiant Research
- Research Solutions, LLC
- SMO-USA, Inc
.- Niche Competitors
- Acurian, Inc
- Advanced Clinical Software
- Almedica International, Inc.
- CB Technologies
- eResearchTechnology, Inc.
- eTrials worldwide, Inc.
- Fast Track Systems, Inc.
- Investigator Support Services
- Pharsight Corporation
- Phase Forward, Inc.
- PHT Corporation
- Veritas Medicine, Inc
APPENDIX: COMPANY DIRECTORY
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
- Figure 1-1: The Drug Development and Approval Process
- Figure 1-2: Enrollment Delays, 1997 vs. 2001
- Table 1-1: Summary of Total and Outsourced Global Research and Development Expenditures 1999-2008
- Figure 1-3: Contract Research Market Share by Organization Type 2002
- Table 1-2: Summary of Contract Research Market 1999-2008
CHAPTER TWO: INTRODUCTION TO CLINICAL RESEARCH
- Table 2-1: Number of IND Submission for Drugs 1992-2002
- Table 2-2: Percentage of Drugs Dropped at Each Stage of Development 1997-2001
- Table 2-3: Key Drug Submission and Approval Statistics 1992-2002
- Table 2-4: NME Review Time Ranges 1994-2002
CHAPTER THREE: CLINICAL TRIALS OPERATIONS
- Figure 3-1: Estimated Drugs/Vaccines in Clinical Trials Worldwide
- Table 3-1: Number of Active Clinical Trials During the Month of March 2003 According to Three Sources
- Table 3-2: Total Average Percent of Clinical Trials during The Month of March for 2001-2003
- Figure 3-2: Enrollment Delays, 1997 vs. 2001
- Table 3-3: Portion of Studies by Number of Weeks Enrollment is Extended
- Table 3-4: Benefits and Risks of Participating in Clinical Trials
- Table 3-5: Clinical Trials Retention Rates, Phases I-IV
- Figure 3-3: The Inclusion of Women in New Drug Clinical Trials: A GAO Study
- Figure 3-4: Percent of Women and Minorities in NIH-sponosored Trials (Aggregate Enrollment Data for all Extramural Research Protocols Funded in 2000)
- Figure 3-5: Percent of Physicians/Nurses Who Have Used EDC
CHAPTER FOUR: COMPETING IN THE CONTRACT RESEARCH INDUSTRY
- Table 4-1: New Paradigm for R&D
- Table 4-2: Improvements in the Drug Development Process Reduce Development Costs
- Figure 4-1: Percent of Global Clinical Research Outsourced
- Table 4-3: Academic Medical Centers vs. Independent Sites: Percentage of Industry-Sponsored Clinical Trials 1991-2001
- Figure 4-2: Number of Sites Purchased by SMOs, 1998-2000
- Table 4-4: Benefits Achieved in Real-Time EDC Deployment
CHAPTER FIVE: CONTRACT RESEARCH MARKET
- Table 5-1: Global Research and Development 1999-2008
- Table 5-2: Top Pharmaceutical Companies Ranked by R&D Spending 2001 and 2002
- Figure 5-1: Median IND to FDA Approval Time per Drug by Major Pharmaceutical Companies 1996-2001
- Table 5-3: Top Biotechnology Companies Ranked by R&D Spending 2001 and 2002
- Table 5-4: Number of Companies with Active Product Development Projects 1997-2002
- Table 5-5: Worldwide Active R&D Projects in Development by Stage 1998-2003
- Table 5-6: Top Therapeutic Categories by Number of Drugs in Development in the United States October 2002
- Table 5-7: Top Therapeutic Drug Categories Worldwide by Number of Projects in Development as of March 2003
- Figure 5-2: Drug Development Outsourcing Expenditures by Phase 2003
- Table 5-8: Total Global and Outsourced Research and Development Expenditures 1999-2008
- Figure 5-3: Contract Research Market Share by Organization Type 2002
- Table 5-9: Contract Research Market 1999-2008
- Table 5-10: Contract Research Market Revenues by Competor Type 1999-2008
- Figure 5-4: CRO Usage: Percent of Projects in which CROs Played a Significant Role, 1993-1999
- Table 5-11: Market Shares of the Publicly-Traded CROs 2002
- Table 5-12: Market Shares of the Leading Site Management Organizations 2003
