A Guide to Patient Recruitment and Retention

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

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)

About Thomson CenterWatch

285

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The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.

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