Roughly 70 to 80% of ovarian cancer cases are diagnosed at an advanced stage,1 where treatment options are limited and eligibility criteria for clinical trial participation become more difficult to meet. While early-stage patients experience over 90% five-year survival rates, that figure plummets to 29% in late-stage disease. Even for those who initially respond to treatment, up to 85% will relapse—often within just 12 to 18 months.2
Add to that mix biomarker variability and uneven global standards of care, and it’s clear that being “protocol-ready” isn’t enough. That status signals a study’s scientific soundness on paper—but not its practical viability at the site level, with real patients under real-world conditions.
“Designing protocols for ovarian cancer trials requires careful consideration of real-world treatment variability, evolving standards of care and disparities in patient access,” says Juan Manuel Carrera, MD, Senior Medical Director, Oncology at Syneos Health. “These elements influence feasibility and must be addressed early as part of a broader operational strategy.”
Bridging the Eligibility and Access Divide
As sponsors aim to enroll earlier-stage and biomarker-defined populations—such as BRCA-naïve or HRD-positive patients—they must also confront a persistent challenge: many patients with late-stage presentation are already disqualified before they reach a trial site. Reaching these patients earlier requires closer collaboration with genomic testing centers, community clinics and referral networks.
“Eligibility criteria on paper don’t capture the full reality of patient access,” notes Dr. Carrera. “What really matters is whether that patient ends up in the right place, at the right time, to enroll.”
For example, potential participants are often lost when relapse is managed locally and the patient is re-treated before being referred to a trial site. In other cases, delays in BRCA or HRD test results (especially when testing is outsourced or not reimbursed) can prevent timely screening. Even eligible patients may miss enrollment windows due to unavailable archival tissue or delayed biopsy access.
“These real-world factors underscore the value of integrating feasibility insights on day one,” says Dr. Carrera.
Site Strategy Is a Competitive Advantage
For clinical trials in ovarian cancer, site feasibility is especially nuanced. Treatment decisions, particularly in maintenance and platinum rechallenge settings, can differ not only across regions and countries but within institutions. Some sites may recommend surgery first; others may recommend systemic therapy. Understanding these differences early is essential to determining which sites can realistically enroll based on the protocol's expectations.
When trial teams proactively address these gaps through early feasibility discussions, clinical walkthroughs or investigator input, they reduce delays and improve downstream enrollment. Tailoring patient outreach strategies to reflect actual treatment pathways helps improve both patient representation and accrual.
ADCs Are the Future, But They Require the Right Trial Design Framework
The approval of mirvetuximab has validated antibody-drug conjugates (ADCs) as a therapeutic class in ovarian cancer, with more assets moving through the pipeline. But designing trials around these agents requires close attention to eligibility criteria, prior lines of therapy and diagnostic confirmation.
In ovarian cancer, most eligible patients for ADC trials will already be heavily pretreated, which adds complexity around timing, biomarker confirmation and availability of archival tissue. If these steps aren’t streamlined upfront, even interested patients may miss the window to enroll.
“ADCs require a different level of operational readiness,” says Dr. Carrera. “From confirming biomarker status to training sites on sample handling, every detail needs to be mapped out long before enrollment starts.”
Operational Readiness in Action
Given the urgency that follows relapse, feasibility assessments in this setting must be swift yet comprehensive. Sponsors can accelerate execution by prioritizing:
- Early, cross-functional collaboration to stress-test feasibility across regulatory, medical and operational teams
- Flexible protocol designs that reflect biomarker definitions, treatment variability and evolving standards of care
- Site engagement rooted in real-world practices, ensuring that trial expectations match diagnostic and treatment realities
"The most effective ovarian cancer trials are those that anticipate change, integrate site realities and align cross-functional teams from day one," Dr. Carrera says.
By investing in feasibility upfront, sponsors not only reduce trial risk but also accelerate access to therapies for ovarian cancer patients who urgently need them.
Contributors
Juan Manuel Carrera, MD | Senior Medical Director, Oncology at Syneos Health
Jozsef Palatka, MD | VP, Medical Management, Oncology at Syneos Health
Citations
- Caruso G, Weroha SJ, Cliby W. Ovarian Cancer: A Review. JAMA. 2025;334(14):1278-1291. doi:10.1001/jama.2025.9495.
- St Laurent JD, Liu JF. Treatment Approaches for Platinum-Resistant Ovarian Cancer. J Clin Oncol. 2024;42(2):127-133. doi:10.1200/JCO.23.01771