Case Study
Overview
A large pharmaceutical company faced a major challenge in reaching effective participant enrollment while conducting a clinical study focused on a potential treatment for nonalcoholic fatty liver disease (NAFLD). Pro-ficiency, a Simulations Plus company, directly addressed these challenges with targeted job aids and a voluntary simulation training module specific to addressing NAFLD and NASH study enrollment challenges.
90% +
of learners in every role reported the job aid to be helpful
70%
of PIs reported the tool as "very helpful"
Challenge
A common challenge for NAFLD-focused studies is slow or inadequate enrollment due to the complexity of inclusion and exclusion criteria. Traditional methods of participant recruitment tend to overlook eligible subjects or fail to effectively convey complex criteria to site staff. This can lead to delays and hinder study progress. The client required timely recruitment and retention of clinical trial participants.
Solution
In order to better identify, attract and retain study participants, the client decided to leverage the Pro-ficiency Performance Management platform. They worked with consultants who developed a specialized quick-release training module, tailored for NAFLD and NASH studies, that was designed to assist study sites in identifying and enrolling eligible subjects. The consultants also provided support, including training on subject groups that were often missed due to temporary criteria, as well as essential job aids that visually represent complex inclusion/exclusion (I/E) criteria.
Key features included:
- Enhanced Criteria Visualization: Job aids that clearly represent complex inclusion/exclusion criteria to ensure accurate subject recruitment.
- Rapid Deployment: The module can be deployed in under a month, addressing immediate enrollment needs.
- Targeted Support: Tools and resources are designed to help sites engage subjects who might otherwise be missed due to temporary criteria or other challenges.
Results
The module was provided to sites as an optional resource. The majority of sites (nearly 500 participants) elected to spend valuable time in the module.
Feedback indicated:
The majority of site staff, in all roles, were invested in learning how to optimize subject enrollment at their site and this simulation training module was not only well received, but also effective for bolstering enrollment.
Discover how the Pro-ficiency Performance Management platform can streamline your study enrollment process.
