Patient Recruitment and Retention in Clinical Trials

Emerging strategies in Europe, the US and Asia

Publication Date	June 2007
Publisher	Business Insights
Product Type	Report
Pages	149
ISBN Number	not applicable
Product Code	RBI00152

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Summary

Patient Recruitment and Retention in Clinical Trials Operational delays in clinical trials reduce patent exclusivity time and shorten the most commercially productive phase of a product's life cycle, resulting in millions of dollars in missed market opportunities for potential blockbusters. The primary source of such delays is the recruitment and retention of patients that fit the trials' profile requirements.

More and more drugs on trial have been designed to attack very specific biological targets. This necessitates the need to identify, recruit and retain patients that fit an increasingly narrower medical profile. Therefore, pharmaceutical companies and clinical research organizations are seeking new ways to optimize recruiting operations and gain a competitive edge
Patient Recruitment and Retention in Clinical Trials is a new report from Business Insights that provides a comprehensive review of patient recruiting strategies, focusing on successful approaches and emerging trends from across the globe. Use this report to understand the attitudes affecting patient and physician recruiting in the U.S, Europe and Japan and identify successful strategies to combat the clinical trials productivity crisis.

Key findings of the report...

Almost half of all trial delays are caused by patient recruitment problems. These delays cost makers of specialty products more than $500,000 in lost sales and they result in losses of over $8m for blockbusters.
The Internet is an important tool to recruit both patients and physicians, but remains under-utilized throughout the US, Europe and Japan.
Clinical research continues to migrate from the U.S. and Western Europe to cheaper offshore locations. Virtually all of the leading CROs and many pharmaceutical companies including Pfizer, Roche, GlaxoSmithKline and Novartis now have an established presence in India, China and Eastern Europe.
In March 2007, the European Medicines Agency's (EMEA) adopted a draft guideline on requirements for first-inman clinical trials for potential high-risk medicinal products, which could further tighten patient recruiting.
In the U.S. and the EU, women continue to be under-represented in clinical trials, and regulators are yet to penalize drug developers for under-investigating effects in women.

Key questions answered in this report * Why are so many clinical trials experiencing patient recruitment shortfalls?

What are the financial advantages to improving clinical trial recruiting?
Why do most recruiters continue to rely on conventional TV advertising to reach patients?
Why does the Internet offer high, but as yet untapped, potential to recruit both patients and physicians?
What growing problem is currently faced by clinical trial recruiters in India?
Which new segment of the CRO industry is experiencing the greatest growth?

Top five reasons to order your copy today * Examine key recruiting trends across the U.S, Europe and Asia and understand emerging problems facing patient recruitment in India and China.

Investigate and benefit from Internet recruiting techniques that offer untapped potential to recruit both patients and physicians.
Stay up to date with competitors' patient and physician recruiting initiatives and identify what can be incorporated into your clinical objectives.
Integrate new recruiting strategies into clinical programs and reduce product launch delays.
Assess the applicability of different recruiting strategies to clinical development programs.

Content

Patient Recruitment & Retention in Clinical Trials
- Executive Summary
- Introduction
- Clinical trial recruitment in the United States
- Clinical trial recruitment in Europe
- Clinical trial recruitment in Asia
- Regional comparison
Chapter 1 Introduction
- Summary
- The global environment for drug development
- More sophisticated science
- More complicated disease targets
- Heightened regulatory scrutiny
- Other imperatives requiring greater drug safety
- Adverse drug reactions
- DTC Advertising
- Internet Sourcing of Drugs
- Rising lawsuits
- R&D cost pressures
- Spending on drug development
- R&D Productivity
- Outsourced R&D
- The importance of clinical trial recruitment
- Growing number and size of clinical trials
- The cost of patient recruitment delays
- Emerging recruitment strategies
- Web-based registries
- Study-specific websites
- Specialized publications
- Proactive targeting measures
- Conversion and retention
- Ethical issues
- Declaration of Helsinki
- Clinician's finder fees
- Participant disclosures
- Conclusions
Chapter 2 Clinical trial recruitment in the US
- Summary
- The clinical trial process
- Contract research
- Recruitment requirements
- Recruitment issues
- Conversion and retention
- Incentives
- Regulations
- Current patient recruitment practices
- Consumer attitudes towards clinical trials
- Online recruitment
- Case study: BBK Worldwide
- National networks
- Electronic alerts in computerized medical records
- Offshore clinical testing
- New initiatives and best practices
- Expansion of early testing
- Including women in clinical trials
- Usage of prisoners
- Streamlining of multiple sites
- Interactive voice response (IVR)
- Current physician recruitment practices
- Physician attitudes towards clinical trials
- Online recruitment
- Data management
- Clinical trial information
- Government sources
- Other sources
- Conclusions
Chapter 3 Clinical trial recruitment in Europe
- Summary
- The clinical trial process
- Contract research
- Eastern Europe
- CRO developments in Eastern Europe
- Other parts of Europe
- Recruitment requirements
- Recruitment issues
- Conversion and retention
- Incentives
- Regulations
- Current patient recruitment practices
- Consumer attitudes towards clinical trials
- Online recruitment
- Case study: Richmond Pharmacology
- New initiatives and best practices
- Bulgaria and Romania
- Including women in clinical trials
- Current physician recruitment practices
- Physician attitudes towards clinical trials
- Online recruitment
- Clinical trial information
- Government sources
- Other sources
- Conclusions
Chapter 4 Clinical trial recruitment in Asia
- Summary
- The clinical trial process
- Contract research
- India
- Patent issues
- CRO developments in India
- China
- Patent Issues in China
- CRO developments in China
- Recruitment requirements
- Recruitment issues
- Conversion and retention
- Incentives
- Regulations
- Japan
- China
- India
- Current patient recruitment practices
- Consumer attitudes towards clinical trials
- Online recruitment
- New initiatives and best practices
- Big pharma clinical trial centers
- Case study: Shanghai
- Ethical issues
- Case study: Chiltern International
- Current physician recruitment practices
- Physician attitudes towards clinical trials
- Online recruitment
- Clinical trial information
- Government sources
- Other sources
- Conclusions
Chapter 5 Regional comparison
- Summary
- Consumer attitudes towards clinical trials
- Demand for access to information
- Impressions of currently available clinical trial information
- Physician attitudes towards clinical trials
- Growth drivers
- Regional impact on patient recruitment
- Regional impact on physician recruitment
- Conclusions
Index
List of Figures
- Figure 1.1: Adverse Drug Events, 1995 - 2006
- Figure 1.2: NME Approvals vs. R&D Spend (1980 - 2006)
- Figure 1.3: R&D Spend per NME Approval by Year (1990 - 2005)
- Figure 3.1: Factors Impacting Study Participation in Europe
- Figure 4.1: Relative importance of Asian pharmaceutical markets, 2007
- Figure 4.2: Japanese drug approval process, 2007
- Figure 5.1: Clinical Study Participation in U.S., EU and Japan, 2005 vs. 2004
- Figure 5.2: How clinical study participants were enrolled in trials
- Figure 5.3: Consumers who have looked for health information for themselves or their children within the past 6 months
- Figure 5.4: Factors Impacting Patient Study Participation in U.S., EU and Japan
- Figure 5.5: Consumers who would return regularly to a website that included clinical trial results
- Figure 5.6: Main obstacles for consumers in accessing clinical trial information online
- Figure 5.7: Likelihood of returning regularly to a clinical trial website by feature
- Figure 5.8: Physicians participating in clinical trials, current vs. planned
- Figure 5.9: How clinical study physicians were enrolled in trials
- Figure 5.10: Factors Impacting Physician Study Participation in U.S., EU and Japan
- Figure 5.11: How clinical study physicians were enrolled in trials
- Figure 5.12: Physician technology utilization in clinical trials by region
- Figure 5.13: Physician access to technology by region
List of Tables
- Table 1.1: Recent US drug recalls, 2000 - 2006
- Table 1.2: US R&D Spend per NME Approved, 1990 - 2005
- Table 2.3: Patient recruitment requirements by clinical trials phase
- Table 2.4: US clinical trial recruitment websites
- Table 2.5: Global operations of leading CROs
- Table 3.6: Eastern European operations of leading CROs
- Table 4.7: US FDA new drug application data generated from India
- Table 5.8: Region-specific growth drivers and restraints for clinical trial activity, 2007