24 September 2017

Case Study: Pediatric Pain

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

Background

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.

 

Challenges

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:

 

Solutions

A thorough risk management plan

An extensive feasibility assessment

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

Clinical execution

  • 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

Smart sites selection strategy

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

An experienced study team: the key to success

  • 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

 

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)
  • Confirmed quality by internal GCP compliance visits performed by KCR QA Department

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.

 

Tools

KCR Trial Execution