How can adaptive monitoring and risk-based SDV boost oncology trials?

Maria had been through surgery, chemo, and the slow churn of scans. When her oncologist mentioned a multicenter trial that might fit, she felt equal parts hope and overwhelm. She used a trial discovery tool to find options and, for the first time in months, spoke with a researcher who explained how monitoring would support—not burden—her participation.

Why monitoring needs to adapt in oncology

Oncology trials span many sites, complex biologic supply chains, and endpoints that evolve with science. Traditional blanket on-site source data verification (SDV) can slow enrollment and distract site staff from patient care. Regulators have pushed change—the 2016 ICH E6(R2) addendum and subsequent FDA guidance encourage risk-based approaches and flexibility for decentralized elements. That shift is what enabled an adaptive monitoring cadence for multicenter oncology trials that balances patient safety with efficient data collection.

A patient-centered example

In one recent academic-led phase II immunotherapy trial, monitors used real-time risk assessments to schedule visits. Low-risk sites received lighter remote oversight; high-enrolling or complex sites had intensified on-site visits. The result: faster query resolution and more time for patient-facing activities. Patients like Maria reported fewer duplicative lab draws and clearer communication when monitoring was tailored to site risk.

• Risk-based SDV strategy for hybrid visits reduced redundant checks while preserving critical source verification
• Adaptive monitoring cadence for multicenter oncology trials allowed resources to follow complexity, not a calendar

Supply chains and endpoints: lessons from other fields

Investigational biologics demand careful logistics. In a commercial oncology trial last year, teams implemented supply chain contingency mapping for investigational biologics—identifying backup cold-chain carriers, alternative storage sites, and staggered shipments—which prevented a weeks-long delay when a regional courier failed. Similarly, the industry has learned from neurology and cardiovascular research: Endpoint harmonization workflows across stroke and hypertension studies demonstrated how standardized definitions and common eCRF modules reduce variability. Oncology trials can borrow those playbooks to align tumor response, QoL, and survival endpoints across sites and cohorts.

Real-world case study

A consortium trial integrating remote patient-reported outcomes and clinic-based imaging piloted a Risk-based SDV strategy for hybrid visits. Remote ePROs were trended centrally; triggers—like a drop in functional status—prompted focused on-site source checks. Monitors verified only critical data points tied to safety and primary endpoints. The trial met key timelines and reported improved site satisfaction.

"I felt like the study team found ways to work around my life, not make me rearrange it," a participant said after a hybrid visit.

Platforms that connect patients and researchers helped participants learn about these studies and manage visit schedules, making it easier for people to weigh treatment options and enroll when appropriate.

Key takeaways

• Focus monitoring where risk is highest: adaptive cadence preserves safety and reduces burden.
• Prepare biologics logistics: supply chain contingency mapping avoids disruption.
• Standardize endpoints: endpoint harmonization workflows reduce variability across trials and disease areas.
• Embrace hybrid models: a Risk-based SDV strategy for hybrid visits keeps critical checks without excess on-site work.

Adaptive, risk-aware monitoring is not just an efficiency tool—it's a way to keep patients like Maria at the center of trial design while meeting regulatory expectations and scientific rigor.