Diagnostics

Perfecting the Recruitment Pipeline in Oncology Diagnostics Clinical Trials

Lindus Staff
Author

Selecting the appropriate site model and patient recruitment tactics are critical to the success of any oncology diagnostics trial. With varying cancer types, demographic factors, and study objectives, a one-size-fits-all approach can’t deliver optimal enrollment, data quality, or timelines. In this blog, we explore three primary site models for recruitment—fully decentralized, hybrid, and traditional clinical sites—and help you identify which model best suits your research needs.

Understanding Your Study Population First

Before selecting a recruitment model, think about the size of your screening population.

Common Screening Populations

For trials involving widely screened cancers like colorectal, breast, prostate, or lung cancer, researchers have access to established screening pathways and larger potential participant pools. These studies often benefit from decentralized or hybrid approaches.

Specialized Populations

For trials involving secondary diagnoses, specific biomarkers (like those for pancreatic cancer), finding the right participants becomes a precision operation. These rare or specialized populations can't rely on broad outreach  – they demand the focused expertise and patient access of clinical sites.

The Three Site Models

Oncology diagnostics trials generally use one of three recruitment frameworks—or a combination—to enroll optimal patient populations.

1. Fully Decentralized Site Model

Structure: A single virtual "site" that deploys mobile phlebotomy or at‑home sample collection alongside remote medical‑record reviews from participants’ regular care providers.

Best For:

  • Large screening populations (CRC, breast, prostate, lung)
  • Broad geographic reach
  • Minimal in‑person specialized testing
  • Studies under tight timelines or budgets

Advantages:

  • Fastest time to enrollment
  • Eliminates geographic and logistical barriers
  • Access to a diverse, representative participant pool
  • Showcases real‑world usability of diagnostic devices
  • Reduces overhead fees by avoiding brick‑and‑mortar sites

Considerations:

  • Standardizing collection procedures can be challenging
  • Requires robust remote monitoring and safety oversight
  • May incur higher screen‑failure rates without robust recruitment strategies

2. Hybrid Site Model

Structure: Combines a virtual site with multiple physical clinical sites that conduct both investigational sample collection and standard‑of‑care procedures.

Best For:

  • Both common and specialized screening populations
  • Studies with a mix of simple home‑based tasks and complex site‑based procedures
  • Projects with moderate timelines and budgets

Advantages:

  • Balances efficiency with procedural standardization
  • Leverages existing healthcare infrastructure
  • Offers insights into device usability in both clinical and real-world settings
  • Supports participant diversity

Considerations:

  • Slower than fully decentralized but faster than site‑only models
  • Requires coordination across virtual and in‑person teams
  • Geographic reach is dependent on site locations

3. Clinical Site Model

Structure: One or more physical sites where all study activities—sample collection, clinical tests, and standard‑of‑care visits—take place.

Best For:

  • Rare or highly specialized cancer populations
  • Studies where timely enrollment is part of inclusion criteria (i.e. must be enrolled within X days of a diagnosis)
  • Studies needing specialized equipment or expertise
  • Studies exploring secondary biomarkers or companion diagnostics to help with treatment choices 
  • Protocols demanding extensive participant monitoring

Advantages:

  • Highest standardization and data accuracy
  • Direct access to medical and laboratory expertise
  • Easier recruitment of niche patient groups

Considerations:

  • Most often see slowest enrollment timelines
  • Limited geographic scope
  • Potential site bias in participant selection
  • Less convenience for participants

Strategic Recruitment Methodologies

Regardless of your enrollment model, targeted tactics can accelerate recruitment and improve data quality.

Digital Advertising

  • Targeted Campaigns: Use demographic, interest, and geofencing filters on platforms like Facebook, Instagram, and Google to reach potential participants.
  • Retargeting: Re‑engage users who’ve interacted with cancer‑related content or visited research sites.
  • Algorithmic Optimization: Let platforms refine audience segments in real time for better conversion.

This method works well for general cancer screening or screening for prevalent cancers (i.e. breast cancer, colon cancer). Fully decentralized trials often rely heavily on digital channels, while hybrid and site‑based studies can use digital ads to drive awareness and direct candidates to physical sites.

EHR Screening

  • Automated Pre‑screening: Leverage diagnosis codes, lab results, and medication histories to identify eligible patients rapidly.
  • Timing Advantage: Identify candidates at critical care points, such as new diagnoses or disease progression.
  • Integrated Outreach: Send invitations via trusted patient portals or SMS notifications.

By leveraging EHR screening at sites with integrated EMR systems, trials targeting patient populations defined by specific diagnoses or biomarkers can significantly reduce screen failures and accelerate enrollment.

Collaborations with Patient Advocacy and Community Groups

  • Built‑in Trust: Leverage credibility from established patient groups and advocacy organizations.
  • Peer Support: Use community ambassadors to share positive trial experiences.
  • Education & Outreach: Host events—both in person and online—to explain study benefits and procedures.
  • Patient‑Centric Feedback: Involve advocacy groups early to refine study design and improve retention.

This approach offers the most value in trials researching diagnostics for rare cancers, where there are limited screening options for timely detection.

Balancing Speed and Cost

Multiple study designs can be combined to balance speed and cost effectively. For example:

  • Begin with decentralized recruitment for rapid initial enrollment, then transition to hybrid or clinical sites for specialized cohorts
  • Use clinical sites for complex procedures while implementing hybrid approaches for follow-up
  • Implement a tiered approach based on geographic availability of specialized centers

Making the Right Choice for Your Study

When selecting the appropriate recruitment model for your oncology diagnostic study, consider these factors:

  1. Cancer type and prevalence: Common screening cancers generally allow for more decentralized approaches
  2. Biomarker or diagnostic specificity: More specialized markers typically require clinical site expertise
  3. Geographic distribution needs: Consider population diversity requirements and regional disease prevalence
  4. Budget constraints: Balance the faster/expensive vs. slower/efficient spectrum based on resources
  5. Timeline requirements: Regulatory deadlines or competitive pressures may necessitate faster approaches
  6. Protocol complexity: More complex procedures generally require more centralized approaches
  7. Data quality requirements: Consider standardization needs across collection sites

Conclusion

No single recruitment model fits every oncology diagnostics trial. By assessing your study’s objectives, population characteristics, and operational constraints, you can select—or combine—models to achieve rapid enrollment, robust data, and cost efficiency. As diagnostics advance toward personalized medicine, recruitment strategies must evolve to meet new challenges.

Ready to optimize your oncology diagnostics recruitment? Lindus Health offers end‑to‑end CRO services—protocol development, data management, and site operations—supported by our Citrus™ eClinical platform that stitches together all the essential tools for study management. Get started with our team to discover how we can support your oncology diagnostics trial’s success from start to finish.

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