In the fast-paced and competitive world of clinical research, planning trials efficiently and effectively is crucial to success. Yet, the complexity of clinical trial feasibility assessments often slows down the process, especially when teams must harmonize both internal insights and vast external datasets. To accommodate this challenge, we’re excited to introduce TA Scan’s Trial Feasibility Flex, designed to empower teams with the flexibility they need to optimize trial planning and execution.
The Challenge: Complexity in Clinical Trial Feasibility
Assessing the feasibility of clinical trials is a multifaceted process. Researchers need to consider a wide range of factors—epidemiology, regulatory timelines, enrollment rates, competing trials, standard-of-care and, the experience and capacity of specific sites—all while tailoring their strategy to the specific trial’s needs. While historical and external data provide essential insights, each trial brings its own unique operational complexities, making the internal expertise of the clinical team essential to strategic planning.
For instance, a recent phase 3 study targeting non-small cell lung cancer patients with EGFR mutations required an unbiased data-driven approach. The sponsor needed to ensure that enrollment projections were realistic, competitive factors were accounted for, and sites had adequate capacity. To address this, the sponsor faced the challenge of balancing relevant high-quality external data with sponsor-specific insights.
The Solution: Trial Feasibility Flex
TA Scan’s Trial Feasibility Flex is a powerful analytics tool, allowing teams to quickly and easily combine high quality global trial intelligence, with their own operational experience to drive precision in enrollment modelling. This innovative solution allows users to customize their feasibility assessments by inputting trial-specific data, including:
- Country Start-Up Timelines: Modify timelines to account for the regulatory delays and operational complexities in specific countries. This flexibility allows users to assess the impact of delayed country start-up on enrollment projections, navigate shifting regulatory landscapes, and set strategic priorities for country activation.
- Signature Country Selection: Select key countries that align with strategic priorities, such as market relevance or local expertise, helping focus resources on the most impactful regions. Adjust anticipated recruitment rates and patient distribution at the country level, allowing prioritization of specific countries and evaluate the impact on enrollment projections more effectively.
- Preferred Site Feedback: Use a preferred site list as input to receive tailored feedback on site capacity and experience. This allows teams to assess if their selected sites can meet enrollment targets and, if needed, access a list of additional relevant sites with proven experience, ensuring effective recruitment even if preferred sites are at capacity.
For the phase 3 study targeting non-small cell lung cancer patients with EGFR mutations, the sponsor needed to leverage advanced analytics to extract actionable insights for more strategic trial planning. By combining tailored inputs with TA Scan’s extensive global trial intelligence and bespoke Monte Carlo simulations, Trial Feasibility Flex generates accurate, predictive enrollment scenarios. This level of customization supports decision-making that is both data-driven and strategically aligned with the organization’s internal insights.
Results: Real-World Impact on Trial Planning
With Feasibility Flex, teams can project country-level recruitment timelines, anticipate delays, and mitigate risks tied to site capacity or competition. In the case of the non-small cell lung cancer study, using this Feasibility Flex allowed the sponsor to:
- Generate Predictive Enrollment Projections: By incorporating sponsor-specific parameters, the sponsor had a more relevant and precise forecast that helped to set realistic enrollment expectations and optimize resource allocation.
- Visualize Country-Specific Timelines: Country-specific timeline visualization with feedback of which countries may face the heaviest recruitment burden or longest recruitment periods helps sponsors prioritize efforts and resources where they’re needed most.
- Understand the Competitive Landscape: By analyzing competing trials in specific geographies, the sponsor could refine their recruitment strategies to avoid overlap with other competing studies targeting the same patient pool.
- Assess Site Capacity: Sites with limited recruitment capacity were flagged, enabling proactive adjustments to the site selection strategy.
Why Trial Feasibility Flex?
By seamlessly integrating internal knowledge with extensive external data, TA Scan’s Trial Feasibility Flex provides flexibility and precision, empowering teams to keep feasibility assessments up to date throughout the life of a clinical trial. Feasibility is a continuous process and with just a few clicks, users can refresh assessments to reflect real-time changes in the competitive landscape, helping teams stay ahead in dynamic trial environments.
For those looking to streamline feasibility processes, Trial Feasibility Flex offers a powerful approach to optimizing country and site selection and driving more reliable patient recruitment. More predictable timelines enable teams to stay on schedule and within budget, helping sponsors meet key milestones with confidence.
For further details on how Trial Feasibility Flex can elevate your clinical trial strategy, check out our full use case fact sheet.
With Trial Feasibility Flex, we’re not just transforming feasibility assessments; we’re empowering researchers to adapt quickly, optimize decision-making, and bring life-saving treatments to patients faster.
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Authored by Elke Ydens, Associate Director of Business Solutions, Data Division
Elke Ydens, Associate Director of Business Solutions at Anju’s Data Division, brings over a decade of life sciences experience and a PhD in Biochemistry and Biotechnology from the University of Antwerp. As a Subject Matter Expert in Data Science, she adeptly addresses customer needs, leveraging her background in neuro-immunology and biochemistry. Elke remains dedicated to professional growth, contributing to industry publications, and staying updated on industry trends, while also finding success in extracurricular pursuits, formerly competing in world and European bridge championships, and more recently active in beekeeping and coaching. Connect with Elke on LinkedIn to explore her achievements further.