TABLE OF CONTENTS
Chapter 1: Executive Summary
Chapter 2: Introduction to Clinical Studies
- Context
- Clinical Trials: Ineffective and Inefficient?
- Patient Recruitment: The Key to a Successful Study
- Sources of Information
- References
- Notes
Chapter 3: Factors Driving the Increasing Length, Size and Complexity of Clinical Studies
- Context
- Increasing R&D Costs
- Increasing Size of Clinical Studies
- The Impact of Pharmacogenomics
- Orphan Drugs Enter the Pharmaceutical Mainstream
- Clinical Trial Transparency
- The Ethics of Clinical Trials
- GCP and the ICH
- References
- Notes
Chapter 4: Barriers to Patient Recruitment
- The Move Away From the Traditional Clinical Trial Participant
- Poor Protocol Equals Poor Recruitment
- Modeling Protocols
- Investigator-Related Issues
- Patient-Related Issues
- Recruitment and Retention in Elderly Patients
- Recruitment Issues in Ethnic Minorities
- Pediatric Clinical Studies
- References
- Notes
Chapter 5: Advertising: Tradition Survives in the IT Age
- Context
- Innovative Approaches to Advertising.
- Augmenting Advertising with Telephone Screening
- References
Chapter 6: Patient Recruitment in the New Media Age
- Context
- An Integrated Approach
- Internet Recruitment
- Virtual Study Sites
- Patient and Healthy Volunteer Databases
- Electronic Informed Consent and Patient Education
- New Media versus Traditional Approaches: "Horses for Courses"?
- References
- Notes
Chapter 7: New Geographical Areas and Patient Recruitment Overview
- Context
- An Expanding Market
- Large Populations
- Cost Benefits
- Issues to Consider
- References
- Notes
Chapter 8: Estimating the Resource Implications of Improving Patient Recruitment and Retention
- Context
- Moving Studies to Low-Cost Countries
- Estimating the Opportunity Costs
- Multimedia Presentations Cut Costs: A Case Study
- References
- Notes
Chapter 9: Ask the Expert
Chapter 10 Company Profiles
- BBK Healthcare, Inc.
- Chiltern International
- ClinPhone Group Ltd
- Covance Inc.
- Clinical Trial Media
- Customized Improvement Strategies LLC
- DDS Medicines Research Ltd
- DxS Ltd
- Fleishman-Hillard, Inc.
- Inveresk, a Charles River Laboratories Company
- Kendle.
- Keris, Inc.
- NourzAds Advertising
- Outcome
- Phase Forward
- PRA International
- Salutis Research
- Thywill LatAm Solutions
- Quintiles Limited
- Verispan LLC
- Veritas Medicine
- Notes
Chapter 11: Toward Effective and Efficient Recruitment and Retention
- Elements in Effective and Efficient Recruitment and Retention
- The Importance of Contingency Plans
- References
TABLE OF EXHIBITS
- Exhibit 2.1 The Clinical Trial Program
- Exhibit 2.2 Average Phase Times and Cost of Clinical Trials by Phase
- Exhibit 3.1 Causes for Compound Failure
- Exhibit 4.1 Using a Simulation to Identify Problems in a Protocol that could Influence Recruitment
- Exhibit 4.2 Targeting Physicians with Greater Patient Availability Leads to Higher Enrollment Rates
- Exhibit 4.3 Factors Influencing Elderly Patients to Participate In a Clinical Study
- Exhibit 4.4 National Institutes Of Healths Ethnic Definitions.
- Exhibit 4.5 Examples of Physiological Functions that May Influence Pharmacokinetic Differences Between Infants and Adults
- Exhibit 5.1 Advert Responses and Screening Activity Using IVR
- Exhibit 5.2 The Candidate Response Funnel
- Exhibit 6.1 Example of an Integrated IT System
- Exhibit 7.1 Clinical Trials Registered By Western Companies in the Ukraine
- Exhibit 7.2 The Members of the European Union
- Exhibit 7.3 Enrollment Rates in Poland, USA and Western European Union
- Exhibit 7.4 Rapid Recruitment in CEESource: Inveresk
- Exhibit 8.1 Total Spending On Clinical Development in the USA
- Exhibit 8.2 Model of Potential Savings Associated with Moving Studies to Low-cost Countries
- Exhibit 8.3 Actual Savings Realized with Multimedia Presentations
- Exhibit 11.1 Essential Elements in Effective and Efficient Recruitment Plans
- Exhibit 11.2 Some Examples of Contingency Plans
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