Conducting clinical trials always has challenges but conducting a first-line trial on advanced stage solid tumor—and targeting only a specific subset and requiring biomarker assessment—is a unique combination of challenges. At Precision, we navigated those difficulties by streamlining the process from day one.
This Phase 3 study in non-small cell lung cancer ultimately encompassed over 230 sites across 17 countries managed with a targeted enrollment of almost 1100 patients. Initially, the protocol focused specifically on untreated Stage IV squamous NSCLC patients, a subset representing only 20-30% of the total NSCLC population. This narrow patient demographic, combined with biomarker assessment requirements and urgent timeline needs, presented significant operational challenges. After meeting that demand successfully, the study expanded to include non-squamous patients, more than doubling the initial patient population to nearly 1100.
Finding treatment-naïve Stage IV NSCLC patients requires precise timing and deep understanding of patient flow patterns. These patients often begin treatment immediately upon diagnosis, creating a narrow window for trial enrollment. Additionally, the requirement for biomarker assessment added complexity to the patient identification process.
Our approach leveraged three key components that enabled rapid site activation while maintaining quality:
The implementation phase demonstrated the effectiveness of our methodology. In the beginning of the study, when we were focused on non-squamous NSCLC, we identified and selected 49 EU sites within three months during the challenging summer period, traditionally a slow time for site activation in Europe. These sites were successfully included in the CTIS submission in August, meeting critical regulatory timelines.
In parallel, we identified more than 40 potential US sites and activated 28 within four months of selection. This rapid activation was possible because of our pre-existing relationships and understanding of site capabilities. Each selected site demonstrated proven ability to:
Our streamlined approach incorporated several innovative elements. The critical path timeline integration aligned all stakeholders from document creation through ethics submission. Start-up specialists worked in parallel with clinical research associates, enabling simultaneous progress on multiple operational fronts.
The process flow prioritized essential document packages while maintaining quality through strategic document review and IP release timing. This careful orchestration of activities eliminated traditional bottlenecks in site activation.
The success of this approach is evidenced by the compressed timelines achieved across both US and EU sites. Despite the challenges of a limited patient population and complex biomarker requirements, the strategic use of site relationships and innovative processes enabled rapid study initiation.
These results demonstrate the value of combining deep site relationships with data-driven selection methods. The ability to activate 77 sites across two regions within four months, while maintaining strict quality standards, establishes new benchmarks for complex oncology trials.
In contemporary drug development, market dynamics demand increasingly compressed timelines while maintaining rigorous quality standards. This case study demonstrates how strategic site selection and parallel processing capabilities directly impact study initiation timelines.
The achievement of activating 77 sites across two regions within four months resulted from three key operational advantages:
These results carry significant implications for sponsors selecting clinical research partners. In the competitive oncology landscape, where patient recruitment windows are narrow and time-to-market is critical, the demonstrated ability to compress site activation timelines while maintaining quality represents a substantial strategic advantage. The integration of site network capabilities with efficient operational processes directly impacts study timelines and, ultimately, development costs—but more than that, repeating patterns of demonstrated success using proven methodologies is where experience and site relationships make a difference. This study evidences how an initial methodology can evolve and form the basis of templated workflow that gets results. Take feasibility for example. Yes, repeated waves of feasibility add a small amount of time, but once the right sites are initiated, enrollment can move incredibly quickly.
This methodology provides a template for future studies targeting narrow patient populations. The integration of site network insights with objective performance metrics and waves of feasibility creates a repeatable process for efficient site selection and activation. This approach is particularly valuable for trials requiring rapid startup in competitive therapeutic areas.
Learn how Precision for Medicine's integrated approach, combining deep site relationships with innovative operational processes, can accelerate your drug development timeline. Contact us to discover how our proven expertise in oncology research can advance your development program.