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.

1. P E D I A T R I C
patient recruitment
Pediatric Trials:
Patient Recruitment
Best Practices
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©2014 Industry Standard Research www.ISRreports.com
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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.
45Minute Telephone
Interviews
64Pages
34Charts and Graphs
15Subject-matter
Experts
1. Company Organization
Company Structures
Outsourcing Behavior
2. Patient Recruitment Specialists
3. Regulatory Difficulties
Regulatory Guidelines
Common Complaints
4. Difficulties of Enrolling Pediatric Patients
5. Enrollment Best Practices
6. Alternative Recruitment Methods
Social Media Usage
Patient Advocacy Group Usage
7. Current and Recently Completed Pediatric Clinical Trial Figures
Report Structure:
Methodologies:
ISR conducted 45-minute in-depth telephone interviews with individuals with experience in pediatric
trial patient recruitment. ISR reached out to pharmaceutical companies, CROs, academic medical
centers (AMCs), research sites, and patient recruitment companies with experience in the process of
pediatric trial patient recruitment.
Secondary data were sourced from company websites, brochures, newsletters, presentations,
government regulatory websites, and various other publications. Clinical trial data were gathered from
www.clinicaltrials.gov.
The titles below are held by our interviewees:
• Clinical Project Manager
• Clinical Research
Coordinator
• Director
• Director, Office for Clinical
and Translational Research
• Director of Business
Development
• Director of Clinical
Development
• Director, Global Clinical
Research
• Director of Marketing and
Patient Recruitment
• Executive Director of
Pediatrics and Rare Diseases
• Pediatric Recruitment Team
Member
• Pediatric Strategist
• Project Leader
• Project Leader
• Project Manager
• Strategic Account Director

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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

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Table of Contents
For full table of contents and additional sample pages, download the full
preview from our website: http://www.isrreports.com/product/pediatric-
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Introduction
www.ISRreports.com ©2014 | Pediatric Trial Patient Recruitment Best Practices 8
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� Recent
research from the Pediatric Working Group of the European CRO Federation outlines
obstacles identified by CROs and pediatricians who have been involved in pediatric trials�
Recruitment issues are listed as the leading obstacle for CROs in pediatric trials�
Main constraints observed in the past with clinical trials in children (multiple
responses allowed):
Source: European CRO Federation, Pediatric Working Group
Clinical trial recruitment is a constantly evolving and heavily regulated aspect of the
clinical development process� Further, pediatric clinical trials introduce another set
of recruitment complications� The Official Journal of the American Academy of
Pediatrics points to patient recruitment as the most difficult aspect of pediatric clinical
trials� Navigating heightened regulations, identifying potential patients, attracting
patients and patients’ families to the trial, and ultimately retaining patients and their
families in a clinical trial make pediatric recruitment an uphill battle�
The process of patient recruitment has multiple moving parts, each of which is analyzed
in this report� Sponsors, CROs, academic medical centers (AMCs), sites, and specialized
patient recruitment companies all play a role in patient recruitment� In some cases,
some of these players work together to conduct the patient recruitment for a trial
and other times a sponsor, CRO, AMC, site, or patient recruitment company will be
individually responsible� This report examines how each of these players operates in the
patient recruitment space and, further, how they interact with each other�
www.isrreports.com
©2014|
Pediatric
Trial
Patient
Recruitment
Best
Practices
7
Introduction
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 possess potential solutions to those issues. The
pediatric trial environment is complicated and recent research from the Pediatric
Working Group of the European CRO Federation outlines some differences between
the obstacles identified by pediatricians who have been involved in pediatric trials and
CROs.
Main constraints observed in the past with clinical trials in children (multiple responses
allowed).
Source: European CRO Federation, Pediatric Working Group
Clinical trial recruitment is a constantly evolving and heavily regulated aspect of the
clinical development process. Further, pediatric clinical trials introduce another set of
recruitment complications. The Official Journal of the American Academy of
Pediatrics points to patient recruitment as the most difficult aspect of pediatric clinical
trials. Navigating heightened regulations, identifying potential patients, attracting
patients and patients’ families to the trial, and ultimately retaining patients and their
families in a clinical trial make pediatric recruitment an uphill battle.
31%
38%
38%
3%
24%
7%
11%
19%
19%
30%
30%
44%
0% 10% 20% 30% 40% 50% 60%
Financial concern/ low investment
Low interest of sponsor
Difficulties in obtaining Ethics Committee
approval
Parental consent
Legislation/ administrative issues
Recruitment issues
CRO
Pediatrician
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Company Organization
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Company Structures
ISR asked respondents how pediatric recruitment work is organized within their
company� Based on the responses heard during the interviews, there are two main
organizational structures that are detailed below�
Therapeutic Focus
Most of the individuals with whom ISR spoke including sponsors, CROs, and AMCs
explained that their recruitment and trial operations functions were therapeutically
aligned� In other words, those individuals responsible for handling non-pediatric
cardiology studies also handle the pediatric cardiology studies� Under this structure,
there is no department fully dedicated to pediatric studies� Subsequently, recruitment
strategies for pediatric studies are often handled in the same manner as non-pediatric
studies – a primary complaint amongst interviewees that will be further examined in
later sections of this report�
Cardiology
CNS
Oncology
Respiratory
Pediatric
and
Non-pediatric
Pediatric
and
Non-pediatric
Pediatric
and
Non-pediatric
Pediatric
and
Non-pediatric
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Sample Page
For full table of contents and additional sample pages, download the full
preview from our website: http://www.isrreports.com/product/pediatric-
trials-patient-recruitment-best-practices/

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