Rescuing Failing Oncology Trials: Insights from a Responsive CRO Partner
Cromos Pharma
US-based international CRO helping clients develop drugs and treatments that save and improve the lives of patients
Oncology trials are among the most complex and high-risk studies in clinical research. Despite their scientific promise, many of these trials fall short—slowed by poor enrollment, underperforming sites, burdensome protocols, or operational breakdowns. With timelines, budgets, and patient outcomes at stake, delays can jeopardize an entire program.
This article explores the key reasons oncology trials fail and outlines practical, field-tested strategies to reverse negative trends and restore progress.
Common Reasons Oncology Trials Fall Behind
Even well-planned oncology trials can experience setbacks. The most frequent contributing factors include:
1. Low Patient Enrollment
Only 7.1% of eligible adult cancer patients in the US participated in treatment trials between 2013 and 2017, reflecting ongoing barriers to awareness, access, and participation.
2. High Patient Burden
A 2023 study found that up to 30% of patients drop out of oncology trials due to frequent visits, travel demands, or logistical strain. Nearly 29% reported site travel as a major burden.
3. Staffing Gaps
A recent report indicated that 95% of cancer centers face staffing shortages. With fewer trained coordinators and research nurses, activation slows, data quality drops, and study timelines slip.
4. Protocol Complexity
According to 2024 data from Tufts CSDD, over 91% of oncology trials require at least one amendment—compared to 72% in non-oncology trials. Each amendment increases cost, delays progress, and raises dropout risk.
5. Lack of Real-World Relevance
Overly restrictive eligibility criteria reduce generalizability. In one analysis of Phase III trials, 20% of real-world patients were ineligible, and high-risk groups saw a 35% lower survival benefit—suggesting design misalignment with clinical practice.
Turning Struggling Trials Around
When a trial starts to lose momentum, early action is essential. A capable partner can help restore performance by addressing both operational and strategic challenges. Key areas of focus include:
Trials limited to a single region often suffer from enrollment bottlenecks and uneven site productivity. Strategic entry into high-performing regions—such as Central and Eastern Europe or select parts of the U.S.—can accelerate recruitment and improve geographic diversity. Success requires familiarity with local regulations, startup timelines, and investigator networks.
Complex or misaligned protocols frequently cause delays. Early design review and targeted adjustments can reduce unnecessary procedures, improve feasibility, and decrease the likelihood of amendments.
Activating new sites quickly—and supporting underperforming ones—is critical when timelines are at risk. Streamlined contracting, regulatory submissions, and dedicated site support teams help bring consistency and speed.
Effective outreach extends beyond traditional channels. Campaigns targeted by region, partnerships with advocacy groups, and patient support logistics can all improve recruitment and retention, especially in difficult-to-enroll populations.
Many lagging trials suffer from unresolved queries, inconsistent data flow, and audit readiness issues. Focused oversight, experienced data teams, and real-time monitoring restore control and protect data integrity.
The goal isn’t just to recover lost ground—it’s to set the trial up for long-term, sustainable success through to completion.
Case Study: How Cromos Pharma Rescued a Failing Phase III Oncology Trial
A multinational Phase III trial in metastatic castration-resistant prostate cancer, covering 19 countries, was critically behind schedule. After 12 months, only 150 of the planned 1,008 patients had been enrolled—putting study viability at risk.
Cromos Pharma was brought in to support rescue efforts. After reassessing feasibility, the team identified underused but high-potential regions in Central and Eastern Europe. The team then:
– Launched operations in five new countries – Activated sites with proven experience in cancer research – Engaged trusted investigators and local KOLs to build visibility and credibility
Outcomes
Takeaway: This case illustrates how a full-service CRO with strong regional presence, deep oncology expertise, and rapid operational capabilities can rescue a failing trial and ensure both speed and quality in critical global studies.
Practical Strategies for Trial Rescue in 2025
Beyond resolving immediate issues, sponsors are increasingly applying proactive rescue strategies. These six insights are shaping recovery efforts across oncology studies today:
1. Rethink Site Feasibility
Involve not just investigators but also coordinators and operational staff early on. This uncovers real-world constraints before launch and improves site selection.
2. Add Decentralized Options
Remote visits, telemedicine, and mobile nursing reduce participant burden and can improve recruitment and retention—especially in geographies with travel constraints.
3. Simplify Data Collection with AI
AI-enabled tools can map EHR data directly into EDC systems, minimizing manual entry and accelerating database readiness.
4. Adopt eSource & Integration
eSource platforms and EHR-integrated systems improve visibility, reduce lag, and speed up query resolution and lock timelines.
5. Define Early Intervention Triggers
Agree on rescue thresholds (e.g., recruitment pace, site performance benchmarks) upfront—so course corrections happen before major setbacks.
6. Use Tokenization for Long-Term Insights
Tokenization allows trial data to be anonymously linked with real-world datasets post-study, enabling richer follow-up without compromising patient privacy.
Cromos Pharma: Operational Support You Can Count On
Cromos Pharma has extensive experience in helping sponsors recover stalled or underperforming trials. Our team provides rapid feasibility reassessment, site re-engagement, patient recruitment support, and hands-on operational management across multiple regions.
We specialize in taking practical action—whether that means launching in new countries, optimizing site performance, or stabilizing timelines and data. Our goal is to support sponsors not just in fixing what's broken, but in finishing strong.
If your trial is off track, we’re here to help you move it forward—quickly, reliably, and with full compliance.