Lactation study for two CGRP receptor therapies
Case study
Overview
ICON partnered with a global large pharma sponsor to conduct a lactation study evaluating the pharmacokinetics and safety of two CGRP receptor therapies in healthy lactating women between one and six months postpartum. The study sought to assess drug excretion into breast milk while meeting strict protocol requirements around postpartum timing, clinic confinement, and participant availability. ICON implemented a patient-centric recruitment and engagement strategy that enabled rapid enrollment, full study completion, and delivery against sponsor timelines despite a challenging recruitment environment.
Challenge
Recruiting lactating women for clinical research can be challenging, and this study presented several additional complexities. Participants were required to be between one and six months postpartum, a narrow eligibility window that significantly reduced the available recruitment pool. Many women in the earliest months after childbirth are still establishing routines and may be reluctant to participate in a clinical trial requiring multiple site visits and overnight stays.
The study consisted of two treatment arms conducted approximately 30 days apart, requiring clinic confinement for three days and two nights in each arm, together with follow-up visits and home visits. Further complicating recruitment, the protocol did not allow infants to stay with participants during their inpatient clinic stays. This created a significant enrollment barrier for potential participants who would need to arrange alternative childcare while managing breastfeeding commitments and family responsibilities.
Success depended on identifying eligible participants willing to meet these requirements while maintaining flexibility around their schedules and individual circumstances. From screening through clinic stays and follow-up visits, careful coordination was essential to minimise participant burden and support retention throughout the study.
Solution
ICON anticipated these recruitment challenges and developed a focused strategy designed specifically for the lactating postpartum population. Targeted outreach initiatives were used to identify potential participants who met the study criteria and were willing to participate despite the domiciling restrictions. Enhanced pre-screening processes helped quickly identify suitable candidates and ensure clear understanding of study expectations before enrollment.
Recognising the importance of flexibility for new mothers, ICON worked closely with participants to accommodate their availability wherever possible. Study teams prioritised proactive communication and scheduling coordination throughout the participant journey, from screening through inpatient stays, follow-up assessments, and home visits. This patient-centric approach helped reduce barriers to participation while supporting compliance with protocol requirements.
By combining targeted recruitment efforts, refined screening strategies, and personalized participant engagement, ICON successfully addressed the study's most significant operational challenge and maintained momentum throughout enrollment.
Outcome
-
15
subjects screened -
6
participants enrolled -
100%
completion rate
Despite restrictive eligibility criteria and complex participation requirements, ICON screened 15 subjects and enrolled 6 participants within a single month. Several participants completed both study arms, and all enrolled participants successfully completed the study, resulting in a 100% completion rate.
Through rapid recruitment, efficient scheduling, and proactive participant management, ICON enabled the sponsor to obtain the required pharmacokinetic and safety data while maintaining study timelines. The team's ability to overcome enrollment barriers reduced operational risk for the sponsor and ensured high-quality study execution in a challenging and specialised patient population.