Pediatric Trials: Patient Recruitment Best Practices

Transcription

1 Brochure More information from 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. 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 Contents: 1. Copyright and Usage Guidelines 2. Sourcing and Methodology - Primary Sources - Interviewee Titles - Secondary Sources - Recommendations and Best Practices 3. Introduction - Impact 4. Company Organization - Company Structures - Therapeutic Focus - Pediatric Consulting with Therapeutic Focus - Outsourcing Behavior - Direction of Outsourcing - Marketing of Outsourcing Capabilities - Implications for Vendors 5. Patient Recruitment Specialists - ClinEdge - Quality Health - Impact of Patient Recruitment Specialists 6. Regulatory Difficulties - Regulatory Guidelines - The Pediatric Research Equity Act (PREA) (From the FDA) - Pediatric Investigator Plans (PIP) - Sponsor Familiarity with Regulatory Guidelines - Common Complaints

2 - Site Perspective - CRO/AMC Perspective - Sponsor Perspective - Source of the Problem: Regulatory Issues - Site Perspective - CROs/AMCs Perspective - Sponsor Perspective 7. Difficulties of Enrolling Pediatric Patients - Patient Recruitment and Retention Obstacles - Age Cohorts/Segments - Frequency of Blood Draws - Educating Patients/Families - Level of Enrollment Expectations - Solution: Population-Based PK Methodology 8. Enrollment Best Practices - Enrollment Motivation - Site Selection - Recruitment and Enrollment Methods 9. Alternative Recruitment Methods - Social Media Usage - Current Use of Social Media - Implications and Future Usage - Patient Advocacy Group Usage 10. Current Pediatric Clinical Trial Figures - Number of Trials by Phase - Study Type Distribution - Number of Interventional Trials by Phase - Number of Observational Trials by Phase - Number of Expanded Access Trials by Phase - Study Type Distribution Funded by Industry Only - Number of Interventional Studies Funded by Industry Only - Number of Observational Trials Funded by Industry Only - Number of Expanded Access Trials Funded by Industry - Average Trial Length (months) - Average Interventional Trial Length by Phase - Average Observational Trial Length by Phase - Average Expanded Access Trial Length by Phase - Projected vs. Actual Trial Length by Phase - Projected vs. Actual Interventional Trial Length by Phase - Projected vs. Actual Observational Trial Length by Phase - Projected vs. Actual Expanded Access Trial Length by Phase - Projected vs. Actual Interventional Trial Length by Phase (Industry Only) - Projected vs. Actual Observational Trial Length by Phase (Industry Only) - Projected vs. Actual Expanded Access Trial Length by Phase (Industry Only) - Average Enrollment by Phase - Average Interventional Enrollment by Phase - Average Observational Enrollment by Phase - Average Interventional Enrollment by Phase (Industry Only - Average Observational Enrollment by Phase (Industry Only) 11. Best Practices and Recommendations Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to

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