CASE STUDY: Turning Feasibility into Competitive Advantage in a Non-Hodgkin’s Lymphoma Trial
Executive Summary
- Therapeutic Area: Oncology – Non-Hodgkin’s Lymphoma
- Geography: United States and Canada
- Challenge: Traditional feasibility approaches often depend on static questionnaire data, which can overlook critical real-world insights that only emerge through direct site engagement. Stiris’ high-engagement feasibility identified an unanticipated off-label use of the comparator drug, creating a significant risk to recruitment and study timelines.
- Result: Early identification of this risk enabled a strategic geographic shift, accelerating Canadian site activation and maximizing recruitment before the comparator product was available. The Canadian sites enrolled 75% of the patients in North America, and the sponsor’s end of recruitment milestone was met early.
Challenge
Stiris was awarded a contract to provide clinical trial management services for a Non-Hodgkin’s Lymphoma study planned across 15 sites in the United States.
As part of the start-up process, Stiris was responsible for conducting feasibility studies to identify and select sites. The feasibility questionnaire was developed collaboratively with the sponsor, and agreement was in place to provide enhanced feasibility (going beyond the questionnaire)
During a direct feasibility discussion with a site Study Coordinator, it was revealed that the comparator drug was being used off-label in the study’s patient population. This insight had not been anticipated by either Stiris or the sponsor and therefore was not captured in the questionnaire.
A traditional questionnaire-based feasibility approach provides limited visibility into real-world site practices, creating a meaningful risk of missing critical insights that can directly impact recruitment feasibility and study timelines. Without this insight, the study would have faced significant recruitment challenges and potential delays.
Solution
As a full-service CRO with a high-engagement feasibility model, Stiris implemented a hybrid approach combining structured questionnaires with in-person, discussions to capture deeper operational insights.
- Conversation-Driven Feasibility
Sites were engaged through real-time conversation, enabling the capture of nuanced insights beyond predefined questions and allowing for dynamic follow-up based on site responses.
- Adaptive Data Capture and Insight Generation
Information was documented during conversations, with the flexibility to explore emerging themes, including off-label treatment practices, that would not surface through static questionnaires.
- Rapid Sponsor Alignment and Strategic Adjustment
Upon identifying off-label use, Stiris immediately aligned with the sponsor to assess implications, and presented solutions which included expanding the study to Canadian sites. After evaluating product availability and projected access timelines, a strategic shift in site allocation was implemented.
Results
Feasibility uncovered a recruitment risk and reshaped the study strategy.
- Early Identification of a Critical Recruitment Risk
Off-label comparator use within the target population was identified during feasibility, preventing downstream recruitment challenges.
- Strategic Geographic Reallocation
Site distribution was adjusted, with just under half of the sites allocated to Canada while maintaining a U.S. footprint.
- Accelerated Canadian Site Activation
Feasibility and start-up activities in Canada were prioritized to capitalize on a limited recruitment window.
- Maximized Recruitment Opportunity
The study leveraged an estimated two-year window before the comparator product was accessible to patients in Canada, protecting enrollment potential.
Sponsor Impact
Stiris enabled proactive decision-making during feasibility by uncovering a critical, previously unrecognized risk in the treatment landscape. Having experts within both Countries, Stiris was able to find a solution very quickly.
Through rapid alignment and strategic execution, the sponsor was able to optimize site allocation, protect study timelines, and maximize recruitment potential in a competitive and evolving clinical environment.
Key Takeaway
- Conversation-driven feasibility uncovers insights missed by traditional questionnaire-based approaches
- Early identification of treatment trends is critical to protecting recruitment timelines
- Real-time sponsor alignment enables faster, more effective strategic decisions
- Geographic flexibility can create competitive enrollment advantages
- Feasibility should function as strategic intelligence, not just data collection
Protect Your Trial from Hidden Feasibility Risks
The difference between a delayed study and a successful one often comes down to what you uncover, and when.
Stiris Research delivers high-engagement feasibility strategies that identify risks early, optimize site selection, and position your trial for success in complex and evolving treatment landscapes.
Connect with us before hidden risks impact your timelines. Contact us info@stirisresearch.com