Case Study Background
Allucent was selected to perform a Phase II study in patients with resectable adenocarcinoma of the colon for an emerging European biotech sponsor. Collaboration began in 2018, and the First Patient In (FPI) was enrolled in Spring 2019. The study spanned several years, concluding in late 2023, and included significant protocol evolution throughout.
Study Design: Randomized, open-label, placebo-controlled, Phase II study (including Part I and Part II) in patients with resectable adenocarcinoma of the colon. Part I was randomized standard design, however in Part II the study transitioned to dose escalation, and ultimately to a randomized dose expansion phase.
Patient Population: Male and female participants diagnosed with adenocarcinoma of the colon, assessed by CT according to TNM classification of colon cancer.
Countries: Spain & Hungary (18 sites)
Services: Full Service
Enrollment:
- Part I: 127 patients
- Part II: 27 patients
Challenges Faced: Managing Recruitment, Protocol Shifts, and Pandemic Disruptions
The study encountered several recruitment challenges due to its complex design and intricate patient pathway. One of the primary challenges was the very short window between diagnosis and standard therapy (surgery). Newly diagnosed patients had to receive 12 doses of the study drug (administered via infusions) within just three weeks before undergoing surgery. This tight timeline placed a heavy burden on both patients and caregivers, particularly elderly participants.
Additionally, the initial protocol required restarting the investigational medicinal product (IMP) after surgery, which led to significant complaints from surgeons. This was later removed via protocol amendment. Over the course of the study, the sponsor implemented multiple design modifications, including changes to inclusion/exclusion criteria and dosing schedules. Part II was redesigned first as a dose escalation phase and then revised again to include a dose expansion phase. These ongoing modifications introduced additional complexity and placed increased demands on sites and study staff.
The study was also conducted during the height of the COVID-19 pandemic, which significantly impacted patient access and site operations. This required continuous feasibility reassessments and the activation of additional sites to maintain recruitment momentum.
Solutions in Action: Streamlining Patient Pathways and Strengthening Site Collaboration
Allucent worked closely with both the sponsor and site teams to navigate the study’s many challenges. A key factor in overcoming obstacles was the strong and proactive communication plan implemented across all stakeholders.
Transparent, two-way communication channels were established between Allucent, the sponsor, and site staff—including oncologists, surgeons, and study coordinators. This enabled quick relay of study updates, clear expectation management, and alignment on changes without disrupting patient care or timelines.
Allucent conducted regular patient pathway assessments to ensure coordination between the principal investigator and the surgical team, helping to keep surgery dates fixed while ensuring patients could still receive all required infusions. To reinforce site support, laminated inclusion/exclusion (INC/EXCL) reference cards were developed, and regular reassessments of internal site communication pathways were maintained. These efforts ensured protocol understanding remained consistent, even through evolving design changes.
A nimble and responsive approach proved essential to keeping the study on track. As the protocol shifted repeatedly, Allucent responded quickly and effectively—keeping sites informed and engaged through every transition. Ongoing site evaluations helped monitor engagement and proactively address concerns. Feedback confirmed that site teams felt supported and informed despite the study’s complexity and duration.
To ease patient burden, a travel concierge service was introduced, including hotel accommodations and/or transportation, as an alternative to traditional reimbursements. This helped maintain retention, particularly given the high number of required infusions within a short window.
To further support the clinical trial recruitment strategies and patient retention, Allucent introduced tailored recruitment tools at the site level and provided enhanced support during the pandemic to ensure continuity and maintain engagement. These personalized, flexible approaches helped address each site’s specific needs and maintained enrollment momentum despite a challenging environment.
Outcomes
Despite significant hurdles—including study design changes, a demanding treatment schedule, and the global COVID-19 pandemic—Allucent successfully achieved both First Patient In (FPI) and overall recruitment milestones ahead of schedule in Part II.
Allucent’s ability to remain nimble, maintain clear and honest communication, and provide consistent support to both sponsor and site teams was instrumental in the study’s success. Site feedback emphasized high satisfaction with Allucent’s transparency, responsiveness, and partnership. The sponsor also expressed strong satisfaction with the team’s performance, highlighting strategic thinking, adaptability, and high-level execution.
This case demonstrates Allucent’s ability to deliver results under pressure, manage complex protocols, and foster trusted relationships that help move clinical research forward.
To learn more about our patient recruitment and site management solutions, visit Patient Recruitment & Retention | Allucent. To read about how Allucent’s focus on operational excellence can support your product development, check out this blog Clinical Research Excellence: Driving Biotech Success
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