Accelerated enrolment in a lactation study
Case study
Overview
ICON partnered with a biotech sponsor to conduct a lactation study evaluating the excretion of a novel NaV1.8 inhibitor into breast milk in healthy lactating women. Conducted at the Salt Lake City clinical research unit, the 29-day study required confinement from day -1 through day 5, outpatient follow-up assessments, and home visits for breast milk collection. The study's objective was to generate critical lactation safety data while recruiting and retaining the participant population.
Challenge
Enrolling lactating women in clinical research is often challenging, especially when studies compete for access to the same pool of participants. During this study, three other lactation trials were actively recruiting from the same pool of potential participants, increasing competition for enrolment. Despite these market dynamics, the sponsor required timely enrolment to support development timelines and obtain the necessary breast milk excretion data.
Success depended on identifying eligible participants and providing a study experience that minimised disruption to their daily lives. Lactating mothers often balance childcare, family responsibilities, and work commitments, making convenience a critical factor in study participation and retention.
Solution
ICON leveraged a participant-focused approach that emphasised convenience and flexibility throughout the study journey. The protocol itself was designed to reduce burden, featuring a relatively short inpatient stay, minimal follow-up requirements, and liberal inclusion and exclusion criteria that expanded the pool of eligible participants.
To further enhance the participant experience, ICON incorporated home visits for breast milk collection, eliminating the need for three additional clinic visits. This approach reduced travel requirements and helped participants more easily balance study participation with their personal and family responsibilities.
Combined with proactive recruitment efforts and efficient study execution, this participant-centric strategy enabled ICON to attract and retain qualified participants despite the very competitive enrolment landscape.
Outcome
-
24
participants screened -
12
participants enrolled -
4
month enrolment period vs. planned 9 months -
3
clinic visits replaced with home visits
ICON screened 24 participants and enrolled 12 lactating women, with all 12 participants completing the study, resulting in a 100% completion rate.
Enrolment was completed in just 4 months, significantly ahead of the planned 9-month enrolment timeline and despite competition from three concurrent lactation studies.
By delivering faster-than-expected enrolment and exceptional participant retention, ICON enabled the sponsor to obtain the required lactation data efficiently while reducing timeline risk and maintaining a positive participant experience.