Overcoming challenges in non small cell lung carcinoma rescue study
Case study
The challenge
A mid sized Pharma organisation was conducting a Phase Ib trial with plans to enroll 188 Non Small Cell Lung Carcinoma patients in Cohort B. The study presented with challenges from the outset. Most notably screening activities were extremely slow without any obvious reasons. Consequently the LPI target date was in danger of being missed and a revised target date being set was not was unacceptable to the client.
The solution
ICON deployed localised Site Engagement Liaisons (SELs) to identify and analyse the issues that were causing this slow down in screening activities. They were able to review the issues and to support immediate actionable tactics within a three week period. This led to an increase in site performance and a significant increase in the number of patients screened.
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 developing corrective action plans
- 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
SEL intervention resulted in a substantial impact on the success of this phase of the study. There was a notable increase in performing sites by up to 71.8%. Site enrollment rates doubled which had the knock on affect of the screening phase being completed 9 weeks ahead of schedule.
