Proactive problem-solving preserves data integrity in lactation study
Case study
Overview
ICON partnered with a mid-sized biotech sponsor to conduct a lactation study evaluating the concentration of an investigational Fc fragment therapy in mature breast milk following administration to healthy lactating women. The study required the recruitment and retention of a specialised participant population while ensuring the collection of high-quality breast milk samples within strict protocol-defined timelines. Through proactive issue management and a patient-centric approach, ICON successfully navigated an unexpected operational challenge, protecting study continuity and data quality, and ensuring successful delivery.
Challenge
Lactation studies present unique operational complexities, requiring participants to balance study commitments with the demands of caring for an infant. In this study, participants underwent a 29-day protocol that included an inpatient stay from day -1 through day 5 and multiple sample collection requirements. Recruiting and retaining qualified lactating women while minimising participant burden was critical to study success.
During study conduct, with two participants already enrolled, an unexpected challenge emerged when an error was discovered in the sample handling instructions contained within the sponsor's laboratory manual, specifically relating to the storage requirements and stability window for breast milk samples. The issue created a significant risk to sample integrity and threatened the continuity of participation for enrolled subjects. Without rapid intervention, valuable study data could have been lost and enrolled participants may have required early termination from the trial.
Solution
Upon identifying the issue, ICON acted immediately to assess the potential impact on participants and study timelines. The team worked collaboratively to develop a solution that would preserve sample viability while minimising disruption to subjects and study operations.
Recognising that time was critical, ICON arranged home visits for affected participants to collect and store breast milk samples within the required stability window and at the required temperature. Study staff coordinated directly with participants to ensure collections were completed promptly and in accordance with protocol requirements. By bringing study procedures directly to participants, the team avoided unnecessary burden while protecting the integrity of the study data.
This rapid, subject-focused response enabled ICON to mitigate a potentially significant protocol risk while maintaining continuity of study conduct and participant engagement.
Outcome
-
20
participants screened -
8
participants enrolled -
15
week enrolment period -
100%
completion rate
ICON successfully screened 20 participants and enrolled 8 participants within 15 weeks, demonstrating the effectiveness of ICON's targeted recruitment and participant engagement strategy.
ICON's proactive intervention prevented the loss of critical study data resulting from the laboratory manual error. By preserving sample integrity and avoiding participant discontinuations, the team maintained study timelines, protected data quality, and reduced operational risk for the sponsor.
Through decisive issue management, flexible participant support, and strong operational execution, ICON delivered a successful lactation study while safeguarding both participant experience and scientific outcomes.