Completion risk
High
Fatigue drives non-completion
Assessment scales
FACT-G
EORTC QLQ-C30 · PRO-CTCAE
Caregiver input
eObsRO
Required in high-burden protocols
Oncology eCOA Model
Capture · Monitor · Support · Recover
Most eCOA vendor evaluations ask the same questions: Is it 21 CFR Part 11 compliant? Can it support BYOD and provisioned devices? Does it have the questionnaires we need? These are necessary, but they are not sufficient for oncology.
Oncology trials carry a compliance profile that almost no other disease area matches. Patients are managing active treatment side effects, scheduling complexity, and significant emotional burden — all while being asked to complete daily diaries and complex validated scales. The software that works well in a metabolic or derm trial may fail structurally in an oncology protocol.
The question is not just whether a vendor has your preferred instrument. It is whether they are built to protect completion when patients are genuinely struggling.
See also: Delve Oncology · eCOA & ePRO Platform
These are the evaluation criteria that actually differentiate vendors in oncology contexts. Generic compliance claims are table stakes — these questions reveal operational depth.
Patients receiving chemotherapy, immunotherapy, or radiation often have predictable windows of fatigue and low compliance. Ask how the vendor's model differentiates between deliberate withdrawal and temporary inability to complete — and what intervention looks like.
In advanced oncology studies, eObsRO workflows are not edge cases — they are critical for capturing patient state when direct completion is not feasible. Vendors who treat this as an add-on create structural compliance gaps.
The metric that separates vendors is not how they track compliance — it is how fast they act on it. In oncology, a 72-hour drift window without outreach can mean multiple missed assessments that are unrecoverable.
Long, complex scales administered at full length to a fatigued patient create abandonment risk. Adaptive or branching logic — where items adjust based on prior responses — reduces burden without sacrificing endpoint validity.
Oncology sites are among the most stretched in clinical research. If the eCOA vendor's compliance model relies on site staff to chase patients, it will fail. Ask whether patient support is built into the platform or bolted on as a billable extra.
Ask for completion rates specifically from oncology programs, not aggregate platform stats. An 85% completion rate in a dermatology study is not evidence of oncology readiness. The disease area matters.
The difference is not the questionnaire library. It is the operational model behind it.
The validated scales commonly used in oncology studies each carry specific completion demands that affect vendor requirements.
27-item base with disease-specific modules. Typically administered at scheduled visits plus between-visit timepoints. Length and complexity increase abandonment risk without adaptive support.
30-item health-related quality of life instrument. Strong regulatory acceptance. Requires accurate recall windows — missed or late completions can compromise data usability at analysis.
Patient-reported version of Common Terminology Criteria for Adverse Events. Designed to capture symptom severity and interference. High face validity but requires consistent completion to be useful.
9-item instrument for fatigue severity. Often administered as a daily diary. Fatigue itself is the barrier to completing a fatigue assessment — this is where human support matters most.
Widely used generic health utility measure. Shorter, but still requires consistency across the study period. Timing violations reduce its analytic value.
Often protocol-specific. Require sponsor-defined completion windows, real-time monitoring, and immediate escalation when entries are late or missing.
Yes. Consistently. The combination of treatment side effects, emotional burden, and complex assessment schedules creates a compliance profile that requires dedicated support infrastructure — not just better software.
eObsRO, or electronic observer-reported outcomes, allows a caregiver or designated observer to complete assessments when patients cannot do so independently. In advanced disease or cognitively impaired populations, it is essential.
Ask for completion rates from oncology programs by disease type. Request examples of how the vendor handled compliance recovery mid-study. Ask whether their support team has oncology-specific training protocols.
Delve combines validated eCOA instruments with proactive compliance monitoring and human concierge support designed for the realities of oncology patient populations.
Talk to Our Oncology Team