Lactation study of an FcRn inhibitor
Case study
Overview
ICON partnered with a mid-sized pharma sponsor to conduct a lactation study evaluating the concentration of a monoclonal antibody therapy in the breast milk of healthy lactating women. Conducted at ICON’s Salt Lake Clinical Research Unit, the study aimed to generate important data on drug excretion into breast milk while enrolling a highly specialised participant population. Success depended on identifying and engaging women willing to meet the study's unique requirements, including a prolonged interruption to breastfeeding. Through a tailored recruitment approach and participant-focused engagement strategy, ICON successfully delivered the study on time while maintaining exceptional participant retention.
Challenge
Recruiting lactating women for clinical trials can be inherently challenging, particularly when study participation requires significant lifestyle adjustments. In this study, participants were required to discontinue breastfeeding for eight weeks following dosing before resuming normal breastfeeding practices. This requirement represented a substantial barrier to enrolment, as many otherwise eligible women were unwilling to interrupt breastfeeding for an extended period.
The protocol required healthy lactating women who were at least six weeks postpartum to participate in a 37-day study that included an initial confinement period (day 1-3), followed by home dosing (day 4-7), and follow-up assessments. Identifying participants who met both the clinical eligibility criteria and the lifestyle requirements of the study required a highly targeted recruitment strategy. Traditional approaches risked generating large numbers of unsuitable referrals and increased screen failures, potentially impacting study timelines and recruitment costs.
Solution
Rather than focusing broadly on all eligible lactating women, ICON refined its recruitment strategy to specifically target women who were already considering or preparing to discontinue breastfeeding. Recruitment messaging was tailored to clearly communicate the study requirements upfront, helping to identify participants whose personal circumstances aligned with the protocol's expectations.
The team complemented targeted outreach efforts with focused pre-screening and participant engagement processes designed to assess eligibility efficiently and minimise unnecessary burden on potential participants. By aligning recruitment efforts with participant lifestyle considerations, ICON was able to improve enrolment efficiency and reduce the likelihood of screen failures.
This participant-centric approach enabled the study team to identify motivated candidates more effectively while maintaining a positive participant experience throughout recruitment and study participation.
Outcome
-
20
participants screened -
15
subjects enrolled -
12
week enrolment period -
100%
completion rate
ICON screened 20 eligible participants and enrolled 15 subjects within 12 weeks, with every enrolled participant successfully completing the study. This high conversion rate demonstrated the effectiveness of the team's targeted recruitment strategy and its ability to align study requirements with participant needs and expectations.
By proactively addressing the study's primary enrolment barrier, ICON accelerated recruitment, reduced the risk of screen failures, and helped maintain study timelines. The successful execution of the trial provided the sponsor with the required clinical data while minimising operational risk and ensuring a high-quality participant experience.
ICON value add
ICON proactively addressed a significant enrolment challenge by tailoring recruitment efforts toward women already prepared to discontinue breastfeeding. This targeted approach improved enrolment efficiency, reduced screen failures, and enabled the team to enrol 15 participants within 12 weeks while achieving a 100% completion rate. By aligning recruitment strategies with participant lifestyle considerations, ICON maintained study timelines, reduced sponsor risk, and delivered high-quality study outcomes.