pediatric trials: patient recruitment best practices
DESCRIPTION
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.TRANSCRIPT
P E D I A T R I Cpatient recruitment
Pediatric Trials: Patient Recruitment
Best Practices
©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.
45
Minute Telephone Interviews
64Pages
34
Charts and Graphs
15
Subject-matter Experts
1. Company Organization
Company StructuresOutsourcing Behavior
2. Patient Recruitment Specialists
3. Regulatory Difficulties
Regulatory GuidelinesCommon 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 planningOutsourcing decisionsRecruitment advertising and strategyAlternative 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
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Introduction
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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�
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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 StructuresISR 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
Pediatricand
Non-pediatric
Pediatricand
Non-pediatric
Pediatricand
Non-pediatric
Pediatricand
Non-pediatric
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