A Guide to Patient Recruitment and Retention

by
Edition: 1st
Format: Paperback
Pub. Date: 2004-06-01
Publisher(s): Centerwatch Inc
List Price: $84.53

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Summary

Patient recruitment and retention are clearly complex and challenging components of the clinical trials process. In the industry's foremost resource, A Guide to Patient Recruitment and Retention, the authors provide a wealth of practical advice and quantifiable examples on every aspect of patient recruitment. This book builds on the success of the original -- A Guide to Patient Recruitment -- by introducing many innovative, multi-faceted strategies designed to recruit and retain patients in clinical trials. Book jacket.

Author Biography

Author Diana L. Anderson, Ph.D., is the President, CEO and Founder of D. L. Anderson International, Inc.

Table of Contents

Part One: Current Landscape and Planning
1(96)
The Patient Recruitment Market: A History and Overview of Today's Issues
3(22)
Introduction
3(2)
A Brief History
5(1)
Professionalizing Recruitment and Retention
6(4)
A Word About Metrics
10(2)
Central Call Centers
12(2)
Market Research
14(2)
Some Newer Ideas and Regulatory Developments
16(3)
HIPPA and Patient Recruitment
19(1)
Summary: A Look to the Future
20(5)
Benchmarking Patient Recruitment and Retention in Clinical Trials
25(20)
Introduction
25(1)
Numbers of Patients Who Volunteer and Enroll in Clinical Trials Annually
26(2)
Characteristics of the Typical Study Subject
28(6)
How Potential Study Participants Identify Clinical Trial Opportunities
34(2)
Motivators of Clinical Trial Participation
36(2)
Industry Spending to Facilitate Patient Recruitment
38(1)
Summary
39(6)
The HIPAA Privacy Rule's Impact on Patient Recruitment
45(16)
Introduction
45(1)
HIPAA Privacy Rule ``Personal Health Information'' (PHI)
46(1)
HIPAA Privacy Rule: The Basics
46(3)
Revocation---the Reliance Exception
49(1)
Other Ways to Obtain PHI for Research Purposes
50(1)
Waiver of Authorization
50(1)
Impact on Patient Recruitment
51(1)
Identifying Patients for a Study Within the Investigator's Practice (within the covered entity)
51(1)
Referrals from Other Physicians
52(1)
Data Mining
53(1)
Advertising and Promotion
54(1)
Special Events
55(1)
Use and Maintenance of Recruitment Databases
56(1)
Patient Retention
56(1)
Summary
57(4)
Facilitating Best Practices: The Need for Standard Operating Procedures and Ongoing Training
61(20)
Introduction
61(1)
Developing Standard Operating Procedures (SOPs)
62(4)
Implementation
66(1)
Various Types of SOPs
67(1)
FDA Regulatory Compliance of Recruitment Materials SOP
67(1)
Recruitment Web Site SOP
68(1)
Pre-Screening/Call Center SOP
69(1)
Metrics Collection SOP
70(1)
HIPAA Privacy Rule SOP Specific to Patient Recruitment
71(1)
The Need for Staff Training in Patient Recruitment
72(3)
Making Training Effective
75(1)
The Next Horizon
76(5)
Decision-Making: Where Subject Recruitment and Ethics Meet
81(16)
Introduction
81(3)
Subject Recruitment
84(1)
Ethical Issues in Subject Recruitment
84(4)
Summary
88(9)
Part Two: Implementation and Process
97(134)
The Patient Recruitment Process: A Science and an Art
99(16)
Introduction
99(1)
A Science and an Art
100(1)
More of a Science
101(3)
The Science of Early Planning
104(2)
The Artistic Side of Patient Recruitment
106(2)
New Ideas
108(2)
Summary
110(5)
Media Buying for Patient Recruitment
115(12)
Introduction
115(1)
Why Mass Media?
116(1)
Media Options
117(4)
Negotiation
121(1)
Media Management
122(1)
The Creative Message
123(2)
Summary
125(2)
Call Centers in Recruitment and Retention
127(16)
Introduction
127(1)
Data Acquisition and Disbursement
128(3)
Screening---Processing the Call
131(2)
Predicting Enrollment
133(1)
Referral Management
134(3)
Working with Media
137(1)
Rate of Enrollment
138(1)
Disqualification Data
139(1)
Retention
140(3)
Budgeting and Contracting in Patient Recruitment
143(24)
Introduction
143(1)
Before Budgeting
144(1)
Answering Key Questions
145(1)
Determining a Recruitment Funnel
145(2)
Considering Budget Factors
147(2)
Choosing a Centralized or Decentralized Budget Model
149(2)
Deciding to Recruit Competitively or Not
151(2)
Drafting a Budget
153(2)
Budget Components
155(2)
Other Budgetary Considerations
157(1)
After Budgeting
158(4)
Contracting
162(3)
Summary
165(2)
The Importance of Retention
167(12)
Introduction
167(1)
The Participant Adherence and Retention Plan
168(2)
Adherence: Issues and Solutions
170(3)
Participant Appreciation and Reinforcement Reduce Attrition
173(1)
Reinforcement
173(3)
Appreciation Items
176(1)
Summary
176(3)
Community, Physician and Consumer Outreach Strategies to Meet Recruitment Goals
179(20)
Introduction
179(1)
Reaching Out to the Community
180(6)
Long Range Outreach
186(3)
Formal Physician Training and Other Long-Term Investments
189(2)
Reaching Out to Special Populations
191(3)
Community Outreach Review
194(5)
Customer Service in Clinical Trials: Making the Patient Experience Meaningful and Memorable
199(10)
Introduction
199(1)
Commitment, Communication, Education and Leadership
200(1)
Defining Customer Service
201(1)
Making Service ``Meaningful and Memorable''
202(1)
Service Principle 1
202(1)
Service Principle 2
203(1)
Service Principle 3
204(1)
Service Principle 4
205(1)
Service Principle 5
205(1)
Creating Customer Magic
206(1)
How Customers Evaluate Service
206(1)
Summary
207(2)
Special Populations: Issues in the Recruitment of Women, Children and Minorities
209(22)
Introduction
209(1)
Regulatory Changes Mandate Including Special Populations in Clinical Research
210(1)
Socioeconomic, Cultural and Historical Factors Affect Recruitment Efforts
211(1)
Recruitment of Women and Minorities
212(1)
Understanding the Need
212(1)
Tuskegee: Today's Tragedy
213(1)
Special Populations Recruitment: Barrier or Challenge?
213(4)
Pediatric Recruitment
217(1)
Overlooked and Understudied
218(1)
A Look at the Children
218(2)
Recruiting Children---And Their Parents
220(2)
Sites That Work
222(1)
Lessons Learned
223(2)
Pediatric Clinical Trials at a Crossroads
225(1)
Summary
226(5)
Part Three: Case Studies
231(54)
The Investigative Site--Third-Party Provider Relationship
233(14)
Introduction
233(1)
Study Awareness
234(1)
Marketing/Advertising Focus
235(2)
External Marketing Strategies
237(3)
Importance of Metric Tracking in Evaluating Marketing Strategies
240(1)
Personalize the Study Experience
241(3)
Summary
244(3)
A Patient Recruitment Rescue Campaign from Contracting to Completion: A Case Study
247(18)
Introduction
247(1)
Case Study Therapeutic Specifics
248(1)
Challenges
248(2)
Program Elements
250(3)
Outcomes
253(2)
Lessons Learned
255(3)
Establishing Metrics
258(1)
The Value of Metrics
259(2)
Summary
261(4)
A Progressive Approach to Patient Recruitment and Retention
265(20)
Introduction
265(2)
Centralized vs. Site-Based Recruiting
267(3)
Tracking Patient Progress
270(4)
Monitoring Site Performance
274(3)
Setting Benchmarks and Projecting Results
277(4)
Summary
281(4)
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