A guide to patient recruitment and retention / Diana L. Anderson.

Format:

Book

Author/Creator:

Anderson, Diana L.

Language:

English

Subjects (All):

Clinical trials--Patients.

Clinical trials.

Employees--Recruiting.

Employees.

Patient Selection.

Clinical Trials as Topic.

Marketing of Health Services--methods.

Organizational Case Studies.

Patients.

Medical Subjects:

Patient Selection.

Clinical Trials as Topic.

Marketing of Health Services--methods.

Organizational Case Studies.

Physical Description:

291 pages : illustrations ; 23 cm

Place of Publication:

Boston, Mass. : Thomson CenterWatch, [2004]

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.

Contents:

Part 1 Current Landscape and Planning 1

Chapter 1 The Patient Recruitment Market: A History and Overview of Today's Issues 3

A Brief History 5

Professionalizing Recruitment and Retention 6

A Word About Metrics 10

Central Call Centers 12

Market Research 14

Some Newer Ideas and Regulatory Developments 16

HIPPA and Patient Recruitment 19

Chapter 2 Benchmarking Patient Recruitment and Retention in Clinical Trials 25

Numbers of Patients Who Volunteer and Enroll in Clinical Trials Annually 26

Characteristics of the Typical Study Subject 28

How Potential Study Participants Identify Clinical Trial Opportunities 34

Motivators of Clinical Trial Participation 36

Industry Spending to Facilitate Patient Recruitment 38

Chapter 3 The HIPAA Privacy Rule's Impact on Patient Recruitment 45

HIPAA Privacy Rule "Personal Health Information" (PHI) 46

HIPAA Privacy Rule: The Basics 46

Revocation

the Reliance Exception 49

Other Ways to Obtain PHI for Research Purposes 50

Waiver of Authorization 50

Impact on Patient Recruitment 51

Identifying Patients for a Study Within the Investigator's Practice (within the covered entity) 51

Referrals from Other Physicians 52

Data Mining 53

Advertising and Promotion 54

Special Events 55

Use and Maintenance of Recruitment Databases 56

Patient Retention 56

Chapter 4 Facilitating Best Practices: The Need for Standard Operating Procedures and Ongoing Training 61

Developing Standard Operating Procedures (SOPs) 62

Implementation 66

Various Types of SOPs 67

FDA Regulatory Compliance of Recruitment Materials SOP 67

Recruitment Web Site SOP 68

Pre-Screening/Call Center SOP 69

Metrics Collection SOP 70

HIPAA Privacy Rule SOP Specific to Patient Recruitment 71

The Need for Staff Training in Patient Recruitment 72

Making Training Effective 75

The Next Horizon 76

Chapter 5 Decision-Making: Where Subject Recruitment and Ethics Meet 81

Subject Recruitment 84

Ethical Issues in Subject Recruitment 84

Part 2 Implementation and Process 97

Chapter 6 The Patient Recruitment Process: A Science and an Art 99

A Science and an Art 100

More of a Science 101

The Science of Early Planning 104

The Artistic Side of Patient Recruitment 106

New Ideas 108

Chapter 7 Media Buying for Patient Recruitment 115

Why Mass Media? 116

Media Options 117

Negotiation 121

Media Management 122

The Creative Message 123

Chapter 8 Call Centers in Recruitment and Retention 127

Data Acquisition and Disbursement 128

Screening

Processing the Call 131

Predicting Enrollment 133

Referral Management 134

Working with Media 137

Rate of Enrollment 138

Disqualification Data 139

Retention 140

Chapter 9 Budgeting and Contracting in Patient Recruitment 143

Before Budgeting 144

Answering Key Questions 145

Determining a Recruitment Funnel 145

Considering Budget Factors 147

Choosing a Centralized or Decentralized Budget Model 149

Deciding to Recruit Competitively or Not 151

Drafting a Budget 153

Budget Components 155

Other Budgetary Considerations 157

After Budgeting 158

Contracting 162

Chapter 10 The Importance of Retention 167

The Participant Adherence and Retention Plan 168

Adherence: Issues and Solutions 170

Participant Appreciation and Reinforcement Reduce Attrition 173

Reinforcement 173

Appreciation Items 176

Chapter 11 Community, Physician and Consumer Outreach Strategies to Meet Recruitment Goals 179

Reaching Out to the Community 180

Long Range Outreach 186

Formal Physician Training and Other Long-Term Investments 189

Reaching Out to Special Populations 191

Community Outreach Review 194

Chapter 12 Customer Service in Clinical Trials: Making the Patient Experience Meaningful and Memorable 199

Commitment, Communication, Education and Leadership 200

Defining Customer Service 201

Making Service "Meaningful and Memorable" 202

Creating Customer Magic 206

How Customers Evaluate Service 206

Chapter 13 Special Populations: Issues in the Recruitment of Women, Children and Minorities 209

Regulatory Changes Mandate Including Special Populations in Clinical Research 210

Socioeconomic, Cultural and Historical Factors Affect Recruitment Efforts 211

Recruitment of Women and Minorities 212

Understanding the Need 212

Tuskegee: Today's Tragedy 213

Special Populations Recruitment: Barrier or Challenge? 213

Pediatric Recruitment 217

Overlooked and Understudied 218

A Look at the Children 218

Recruiting Children

And Their Parents 220

Sites That Work 222

Pediatric Clinical Trials at a Crossroads 225

Chapter 14 The Investigative Site

Third-Party Provider Relationship 233

Study Awareness 234

Marketing/Advertising Focus 235

External Marketing Strategies 237

Importance of Metric Tracking in Evaluating Marketing Strategies 240

Personalize the Study Experience 241

Chapter 15 A Patient Recruitment Rescue Campaign from Contracting to Completion: A Case Study 247

Case Study Therapeutic Specifics 248

Challenges 248

Program Elements 250

Outcomes 253

Lessons Learned 255

Establishing Metrics 258

The Value of Metrics 259

Chapter 16 A Progressive Approach to Patient Recruitment and Retention 265

Centralized vs. Site-Based Recruiting 267

Tracking Patient Progress 270

Monitoring Site Performance 274

Setting Benchmarks and Projecting Results 277.

Notes:

Includes bibliographical references.

ISBN:

193062445X

OCLC:

56189297