Overcoming challenges in gastric cancer rescue study

The Challenge

A large biopharmaceutical company with a Phase III trial enrolling 430 advanced Gastric Cancer patients contracted ICON to support patient enrollment. Screening activities were extremely slow with causes for this unknown. There was also a higher than predicted screen failure rate. Consequently the LPI target date was in jeopardy and had to be stretched stretched by two months.

The Solution

ICON deployed localised Site Engagement Liaisons (SELs) to identify and analyse the issues that were causing the slow pace in screening activities. The SELs were able to identify the cause and introduce actionable tactics to aid with screening activities.

ICON’s Value Add

SELs work with sites to provide customised solutions to meet the patient recruitment challenges of specific studies. They have global insight into recruitment best practices and are able to share ideas and solutions across sites in different countries.

Support sites remotely or on-site as necessary with some of the following activities

Translating protocol requirements into the sites’ daily routine
Reviewing and identifying gaps in site process for patient identification and develop corrective action plan
Developing site specific recruitment strategies based on local resourcing, site infrastructure and recruitment potential
Working with local centres to facilitate referrals to main centre
Reviewing site pre-screening process to identify potential subjects
Collaborating and exchanging information between site and study teams

The Outcome

The SEL intervention had a significant impact on enrollment activities, much was accomplished in a short period of time. The intervention had a significant impact on the success of this phase of the study. There was a notable increase in conversion of screened to randomised patients from 30% to 76%. Screen failure rates more than halved in the sites where SELs were involved and the screening phase was completed 3 months ahead of the stretched target.