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.
Complex Patient Population Challenges
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.
Strategic Site Selection Methodology
Our approach leveraged three key components that enabled rapid site activation while maintaining quality:
- First, we implemented site tiering and country scoring metrics that went beyond traditional feasibility assessments. These metrics incorporated historical performance data specific to NSCLC trials, biomarker testing capabilities, and demonstrated the ability to identify treatment-naïve patients. This data-driven approach allowed us to predict site performance with greater accuracy.
- Second, through the Precision Site Network, we conducted pre-award site level feasibility that included study-specific feedback. This network provided crucial insights into local patient populations and referral patterns. Sites shared detailed information about their NSCLC patient volumes, helping identify centers most likely to encounter eligible patients.
- Third, we executed feasibility assessments in parallel with site selection, focusing on pre-qualified sites. This approach compressed traditional timeline barriers while maintaining quality standards. The pre-qualification process emphasized sites with established infrastructure for rapid study start-up and documented success in similar trials.
Operational Excellence in Implementation
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:
- Identify newly diagnosed Stage IV NSCLC patients
- Complete biomarker testing within protocol timelines
- Process regulatory and ethics submissions efficiently
- Execute study contracts quickly
Process Innovation
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.
Impact and Outcomes
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. 
Lessons Learned: Strategic Advantage Through Operational Excellence
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.
Critical Success Factors
The achievement of activating 77 sites across two regions within four months resulted from three key operational advantages:
- Utilization of a sophisticated site network with data-driven tiering and scoring metrics enabled precise site selection.
- Implementation of parallel processing workflows accelerated traditional timelines without compromising quality.
- Leveraging of re-existing site relationships to facilitate rapid study initiation in a challenging patient population.
- Feasibility executed in repeated waves also drives success. The climate can change through the course of a study, and repeated waves of feasibility analysis is the only way to have solid data.
Strategic Implications for Sponsors
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.
The Precision Difference
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.
