Navigating The Enrollment Bottleneck In Early Oncology Trials

Enrollment challenges in early-phase oncology trials remain a critical barrier to drug development, with nearly one-third of cancer studies failing to meet recruitment goals and up to 25% closing prematurely. Despite patient willingness, only 2–5% of adults with cancer participate in trials, largely due to systemic and logistical obstacles. These include stringent eligibility criteria, complex protocols, and provider-level limitations such as time constraints and lack of awareness.

Addressing these issues requires a multifaceted approach. AI-driven prescreening tools can streamline patient identification, while enhanced engagement strategies, such as dedicated staff for consent and logistical support, can reduce patient burden. Additionally, integrating healthy participants for early pharmacology studies offers a complementary solution, enabling faster recruitment, cleaner PK/PD data, and more rational dose selection before exposing vulnerable patients to non-therapeutic doses. This approach aligns with the shift toward biomarker-guided dosing rather than maximum tolerated dose strategies. Ultimately, overcoming enrollment bottlenecks demands collaboration among researchers, clinicians, and sponsors to design trials that balance scientific rigor with patient realities.

Access the full resource to explore actionable strategies for accelerating oncology trial enrollment and improving development timelines.