Careful site selection and detail risk mitigation plan - key to successful patient recruitment.

1. CASE STUDY
Pediatric 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: effective Project Management
(PM), thorough Feasibility Study (FS) leading to smart sites selection, Sites Start-up (ST) including trainings and Investigators
Meeting organization, Regulatory Affairs (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 definition of targeted post-surgical subjects required careful consideration in three key areas:
sites profile; 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 RECRUIT
KNOWLEDGE TO RETAIN

2. Solutions
A THOROUGH RISK MANAGEMENT PLAN
Planned a feasibility assessment and performed a
review of local SoCs for post-surgical pain
management
AN EXTENSIVE FEASIBILITY
ASSESSMENT
Analyzed the eligibility of various surgical procedures
in the light of protocol restrictions
Contacted over 40 potential investigational sites
with varying profiles 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
Effective 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 SELECTION
STRATEGY
Determined the best target surgical interventions:
appendectomy, urology and trauma
Contracted departments of various profiles:
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 Affairs Teams
AN EXPERIENCED STUDY TEAM:
THE KEY TO SUCCESS
Identified 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

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 confidence.
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 confidence 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.
Confirmed 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