臨床研究における被験者募集・確保の向上

Abstract

Patient recruitment and retention currently represents a critical bottleneck in clinical research and drug development. For example, in some cases, (e.g. breast cancer in the USA) the supply of patients may be inadequate to fully assess all the drugs currently in the pipeline. Furthermore, clinical studies account for around half of the billion-dollar cost of drug development. Clinical studies are also becoming larger, longer and more complex. Therefore, there is a pressing need to reduce costs and get drugs to market more rapidly. But many clinical studies are both ineffective and inefficient. Some 70% of sites miss their recruitment target, for example. The report covers the scientific aspects that contribute to the bottleneck, including enrolling of an appropriate race, age and pharmacogenomic profile to represent patients likely to receive the drug in clinical practice and access to naive patient populations.

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

• Participants
• Notes

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