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Pediatric Trials: Patient Recruitment Best Practices

  • July 2014
  • -
  • Industry Standard Research
  • -
  • 64 pages

Recruiting clinical trial participants is hard. Recruiting pediatric clinical trial participants is even harder and with recent regulatory changes, the number of pediatric trials is expected to increase. This report addresses some of the factors that negatively impact pediatric trial patient recruitment and poses potential solutions to those issues.

Report Overview

Recruiting clinical trial participants is hard. Recruiting pediatric clinical trial participants is even harder and with recent regulatory changes, the number of pediatric trials is expected to increase. This report addresses some of the factors that negatively impact pediatric trial patient recruitment and poses potential solutions to those issues.

What you will learn in this report:

• Sponsor company organization and outsourcing behavior
• Insight from pediatric patient recruitment specialists
• Common complaints from sites, sponsors, and CROs/AMCs
• Pediatric patient recruitment and retention obstacles and solutions from subject matter experts for overcoming those obstacles
• Use and effectiveness of alternative methods (social media and patient advocacy groups) in pediatric trial recruitment
• Number, length, and enrollment figures of ongoing pediatric trials based on data from clinicaltrials.gov
• Best Practices for: Drug development planning Outsourcing decisions Recruitment advertising and strategy Alternative recruiting methods

How you can use this report:

• Anticipate potential problems in pediatric patient recruitment in order to reduce trial delays
• Understand regulatory guidelines for pediatric trials and difficulties these guidelines pose for patient recruitment companies, sites, sponsors, CROs, and AMCs
• Benchmark your company’s pediatric recruiting structure to those of other companies outlined in the report
• Vendors: understand how to best market your pediatric recruitment capabilities
• Understand the bigger picture of the pediatric recruitment process.

Table Of Contents

Pediatric Trials: Patient Recruitment Best Practices
Table of Contents

Copyright and Usage Guidelines ..4
Sourcing and Methodology ..5
Primary Sources ...5
Interviewee Titles 5
Secondary Sources ...6
Recommendations and Best Practices .6
Introduction .7
Impact 10
Company Organization ..11
Company Structures ..12
Therapeutic Focus .12
Pediatric Consulting with Therapeutic Focus 13
Outsourcing Behavior 14
Direction of Outsourcing ...14
Marketing of Outsourcing Capabilities .14
Implications for Vendors ...15
Patient Recruitment Specialists .16
ClinEdge .17
Quality Health 18
Impact of Patient Recruitment Specialists .20
Regulatory Difficulties 21
Regulatory Guidelines 22
The Pediatric Research Equity Act (PREA) (From the FDA) 22
Pediatric Investigator Plans (PIP) ...23
Sponsor Familiarity with Regulatory Guidelines 23
Common Complaints .24
Site Perspective ..24
CRO/AMC Perspective ...25
Sponsor Perspective ...26
Source of the Problem: Regulatory Issues .27
Site Perspective ..28
CROs/AMCs Perspective .28
Sponsor Perspective ...30
Difficulties of Enrolling Pediatric Patients ..31
Patient Recruitment and Retention Obstacles ..32
Age Cohorts/Segments ..32
Frequency of Blood Draws .34
Educating Patients/Families ..34
Level of Enrollment Expectations ..35
Solution: Population-Based PK Methodology ...36
Enrollment Best Practices ..37
Enrollment Motivation .38
Site Selection 40
Recruitment and Enrollment Methods ..41
Alternative Recruitment Methods .43
Social Media Usage 44
Current Use of Social Media ...44
Implications and Future Usage ..45
Patient Advocacy Group Usage ..46
Current Pediatric Clinical Trial Figures ...47
Number of Trials by Phase .49
Study Type Distribution .49
Number of Interventional Trials by Phase .50
Number of Observational Trials by Phase .50
Number of Expanded Access Trials by Phase .51
Study Type Distribution Funded by Industry Only .51
Number of Interventional Studies Funded by Industry Only .52
Number of Observational Trials Funded by Industry Only 52
Number of Expanded Access Trials Funded by Industry 53
Average Trial Length (months) ..53
Average Interventional Trial Length by Phase ...54
Average Observational Trial Length by Phase 54
Average Expanded Access Trial Length by Phase ...55
Projected vs. Actual Trial Length by Phase 55
Projected vs. Actual Interventional Trial Length by Phase .56
Projected vs. Actual Observational Trial Length by Phase .56
Projected vs. Actual Expanded Access Trial Length by Phase 57
Projected vs. Actual Interventional Trial Length by Phase (Industry Only) 57
Projected vs. Actual Observational Trial Length by Phase (Industry Only) 58
Projected vs. Actual Expanded Access Trial Length by Phase (Industry Only) ...58
Average Enrollment by Phase .59
Average Interventional Enrollment by Phase .59
Average Observational Enrollment by Phase .60
Average Interventional Enrollment by Phase (Industry Only ..61
Average Observational Enrollment by Phase (Industry Only) .61
Best Practices and Recommendations ...62
About Industry Standard Research 64

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