Why Efficiency Matters More Than Ever in Oncology Drug Development

Written by:
Dr. Daniel Mazzolenis, SVP in Medical Management at Syneos Health

Cancer research has transformed the outlook for millions of patients over the past several decades. Once considered incurable, many cancers now have treatment options that extend life, improve quality of life or even offer the possibility of a cure.

Yet despite this momentum, enormous unmet patient needs remain. Pancreatic and lung cancer, among others, continue to carry poor prognoses. Access to cutting-edge therapies is uneven across geographies, and costs are escalating at a pace that threatens sustainability for patients, providers and payers alike. In this environment, efficiency in oncology drug development is not optional — it is a necessity.

Oncology drug development is uniquely challenging when compared with other therapeutic areas. Oncology studies see an average of 121 protocol deviations in Phase II, versus 76 in non-oncology trials. This means more amendments; more burden on patients and more delays in bringing therapies to market.

At the same time, clinical trial costs in oncology are among the highest in the industry. Phase III studies can range from $20 million to over $100 million depending on region and scope. Average per-patient costs are daunting, too.

A further barrier is site availability. Sponsors gravitate toward established academic centers and experienced sites, which face saturation, competing for a limited pool of patients. While it is in the collective interest of the industry to expand the site base into community-based models and new geographies, each sponsor tends to default to their “familiar” high-performing sites. This prisoner’s dilemma results in bottlenecks, slower recruitment and ultimately longer timelines while patients wait on breakthrough therapies.

Expanding into community centers and underrepresented regions is essential. Doing so not only alleviates saturation but also increases trial diversity, enhances generalizability of results and accelerates enrollment.

Patients in oncology face uniquely high trial burdens. Frequent clinic visits, invasive monitoring, and complex protocols often contrast sharply with simpler access to currently approved therapies — particularly in high-income countries. For biosimilar approvals, patients may be asked to undergo trials that offer little or no personal clinical benefit, raising questions about proportionality of patient burden to societal gain. Addressing patient burden means rethinking trial design:

• Reducing non-core requirements
• Leveraging digital tools and remote monitoring
• Ensuring respect for patients’ existing treatment experiences

A patient-centric approach not only improves recruitment and retention but also enhances the ethical foundation and discovery timelines of oncology research.

The pursuit of efficiency in oncology trials is often misunderstood as a trade-off against quality or safety, when in fact, it can enhance both as well as make progress sustainable. Without it, the soaring costs of development will limit innovation, restrict access and slow delivery of life-saving therapies.

Several strategies are already reshaping the efficiency landscape:

1. Streamlined Biosimilar Development
   Regulatory requirements for biosimilars are evolving. Instead of large, resource-intensive comparative trials, well-characterized molecules can now increasingly demonstrate biosimilarity through preclinical data and simplified clinical designs. This lowers entry barriers, encourages more production, and ultimately drives down costs for patients and health systems.
2. Flexible Trial Designs
   Model-based analyses suggest meaningful efficiency gains: For example, a Health Economics Review study published by BioMed Central estimated that increasing clinical trial success rates through adaptive design approaches could lower average development costs per approved drug from approximately $2.6 billion to $2.2 billion — a reduction of about 15%.
3. Fair Reimbursement and Patient Support
   Offering adequate financial support for trial participation not only offsets patient burden but also enhances corporate reputation and fosters long-term trust in the clinical research enterprise.
4. Risk-Based Monitoring and Data Privacy
   Proactive risk management and smarter data-capture strategies allow CROs and sponsors to safeguard patient privacy while streamlining operations.
5. Inclusive Trial Design
   Meaningful inclusion of patients, advocacy groups, and healthcare professionals in trial design align with the latest revision of ICH E6(R3). By incorporating community perspectives starting at protocol development, sponsors can drive outcomes that truly matter to patients.

CROs play a pivotal role in enabling efficiency without compromising scientific or ethical standards. By centralizing expertise and infrastructure, CROs empower healthcare companies of all sizes to bring forward innovative therapies that might otherwise never reach patients.

The mission is clear:

• Operational excellence ensures that limited R&D dollars stretch further, enabling more candidate therapies to be evaluated.
• Scientific and medical expertise maintains the highest ethical safeguards while minimizing unnecessary patient burden.
• Global site networks and community care models expand access and accelerate enrollment.
• Innovative solutions — from digital platforms to decentralized trial methods — eliminate inefficiencies that once seemed inevitable.

By reducing inefficiency, CROs both protect patients and speed access to potential therapies. This is not only good science — it is also a moral responsibility.

As we plan for another year, oncology drug development stands at a crossroads. The science has never been more promising, but the system delivering new therapies is under unprecedented strain. Without a relentless focus on efficiency, we risk leaving countless patients behind.

For CROs and their partners, the path forward is clear: continue driving efficiency at every stage of development, from protocol design to patient engagement. By doing so, we make it possible for more therapies to reach more patients, more quickly, and at costs healthcare systems can sustain.

Efficiency is not a shortcut. It is the enabler of progress, equity, and hope for millions of people living with cancer globally.

About the Author

Daniel Mazzolenis, MD, MBA, currently serves as Senior Vice President, Medical Management, Oncology & Hematology at Syneos Health. He is a seasoned physician-executive blending deep clinical insight with strategic leadership. With a background in hematology, internal medicine and pharmacology, Dr. Mazzolenis has shaped medical strategy across rare and non-malignant hematologic disorders. He thrives at the intersection of science and execution, mobilizing cross-functional teams to bring innovative therapies to patients. Dedicated to mentoring the next wave of life sciences leaders, Dr. Mazzolenis champions operational rigor, data-driven decision making and a mission to accelerate meaningful change in biopharma.