CASE STUDYPediatric pain

CAREFUL SITE SELECTION AND DETAILED RISK MITIGATION PLAN - KEY TO SUCCESSFUL PATIENT RECRUITMENT

An analgesic compound study in the US experienced recruitment problems, creating serious delays in the project timeline. The compound, designed for short-term management of moderate-to-severe pain requiring analgesia at the opioid level, was initially registered for use in adult patients. Critical clinical data was now required for patients in the 12- to 17-year-old age range in order to extend the approval. The rescue strategy included the implementation of the following services: e�ective Project Management (PM), thorough Feasibility Study (FS) leading to smart sites selection, Sites Start-up (ST) including trainings and Investigators Meeting organization, Regulatory A�airs (RA) for study timely authorization, Clinical Monitoring (CM) and Site Management (SM), Clinical Trial Supply Services (SS) including study drug import from the US and PK samples distribution.

The most critical issue was a diverse target population. The study required patients in age ranges of 12-17, as well as cohorts in the 18- to 64-age bracket. The broad de�nition of targeted post-surgical subjects required careful consideration in three key areas: sites pro�le; types of surgical procedures; and investigator specialization.

Main operational challenges:

Background

Challenges

PK procedures in pediatric patients necessitating an

intensive sampling schedule

Pain scales use in pediatric subjects

Rescue medication – PCA not being standard in many European sites

Procedural requirements for pediatric patient

consent

KNOWLEDGE TO RECRUITKNOWLEDGE TO RETAIN

Solutions

A THOROUGH RISK MANAGEMENT PLAN

Planned a feasibility assessment and performed a review of local SoCs for post-surgical pain management

AN EXTENSIVE FEASIBILITYASSESSMENT

Analyzed the eligibility of various surgical procedures in the light of protocol restrictions

Contacted over 40 potential investigational sites with varying pro�les of surgery wards

Continued the feasibility activities after the project approval by RA and EC and during the recruitment phase, due to a challenging target population

Pre-selected backup sites

Thorough training for Study Teams at all investigational sites

Revisited the least-experienced sites (by PM) to ensure the full understanding of the project

Extensive and proactive clinical monitoring approach

E�ective communication between the Study Team and the Investigator Teams in all sites

Active analysis of the recruitment and SF causes on a daily basis by PM to enable prompt reaction to any possible issues

CLINICAL EXECUTION

Selected 7 investigational sites: 2 general surgery wards for adult patients; and 5 pediatric surgical sites for pediatric subjects

SMART SITES SELECTIONSTRATEGY

Determined the best target surgical interventions: appendectomy, urology and trauma

Contracted departments of various pro�les: pediatric surgery and urology; general pediatric surgery ward; intensive care and pediatric anesthesiology unit

Targeted only planned surgeries, due to the requirement for parents to sign the ICF

Activated a dedicated, professional and experienced Study Team

Engaged a Clinical Research Manager with 12 years of clinical trial experience to lead the project

High engagement of CRAs, CTAs, Regulatory, Legal and Medical A�airs Teams

AN EXPERIENCED STUDY TEAM:THE KEY TO SUCCESS

Identi�ed initial risks at the proposal stage

1

Developed a detailed Risk Exposure Assignment Matrix early in the process

Continually reassessed risks during the entire project

2

Prepared a proper Mitigation Plan

3

KCR is a Contract Research Organization (CRO) providing strategic clinical development solutions for the pharmaceutical, biotechnology and medical device industries. We have the knowledge to recruit and the knowledge to retain patients. Our successful approach combines KCR’s geographic coverage and a portfolio of sophisticated recruitment tools that allow us to approach the most challenging projects with con�dence.

For more please visit www.kcrcro.com or contact us at info@kcrcro.com Copyrights © 2016 KCR All rights reserved

Results

Received RA and EC approvals on time; the silent approval was granted 60 days after submission

Contracted 7 public hospitals with no substantial delays

Achieved patient recruitment target within timelines (13 adults and 40 adolescents enrolled within 32 weeks of recruitment)

The Pediatric Pain Study Sponsor expressed con�dence in KCR’s ability to continue delivering impressive results. KCR has been awarded an even more demanding study related to the same compound administered to children ages 2 to 11.

Con�rmed quality by internal GCP compliance visits performed by KCR QA Department

Operational

Site Management Booster Tools

Lessons Learned Meetings

Incentives for Patients / Sites / Investigators

Resourcing

Site coordinator

Dedicated Study Enrollment Physician

Marketing

Industry Conferences

Patient Networks

Advocacy Groups

Tools