Escalating site burden and cost: What’s driving the surge in oncology investigator grants over the past decade.

Abstract

e23149 Background: Publicly accessible data and industry analyses strongly confirm that site costs, including investigator grants, have risen steadily from 2015–2025, especially in oncology, which remains the most complex and expensive therapeutic area in clinical research. Leveraging proprietary data, Premier Research analyzed historical investigator grant pricing to identify the key cost drivers contributing to rising investigator fees. Methods: Based on the review of more than 170 site budgets, per-patient investigator grant costs increased approximately 133%-175% from 2015-2025. In 2015, average per-patient investigator grant costs on a Phase I oncology study were $30,000-$40,000; by 2025, costs for comparable studies have more than doubled to $70,000–$110,000 per patient. The Trial Cost Estimates model shows a consistent rise in clinical trial costs from 2015–2025, driven by trial complexity, regulatory uncertainty, and data-intensive protocols. This added complexity increases Principal Investigator (PI) and Sub-Investigator oversight effort, data entry, monitoring visit coordination, and study visit assessments, directly impacting site budgets and personnel workload, given their time- and procedure-based structure. Further, 81.5% of oncology clinical trials undergo at least one protocol amendment, which can have significant impact on trial budgets. Results: Premier’s data revealed that personnel costs were one of the largest drivers of rising investigator grant fees from 2015-2025. Post-COVID, beginning in fiscal year 2021, the industry experienced widespread and significant salary inflation among key personnel at academic sites. Based on publicly available data across multiple academic medical centers, it was discovered that oncology PI salaries increased by an average of 24% from 2021-2025, while clinical research coordinator salaries rose by approximately 33% over the same period. Apart from increased trial complexity and salary inflation, other notable drivers contributing to rising investigator grant costs include site start-up fees (increasing by > 46%), IRB fees (increasing by > 56%), and pharmacy handling fees (increasing by > 53%). Site indirect or overhead (OH) costs also increased. While variable by institution, data from 20 US-based oncology academic centers shows an average OH fee increase of approximately 10-15%, rising from 30-35% in 2015 to 40-50% in 2025. Conclusions: In summary, oncology site investigator grants have surged over the past decade with rising protocol complexity, amendment frequency, expanding data and operational burdens, escalating PI/CRC staffing costs, and steadily increasing institutional overhead and site fees. These factors have collectively driven a substantial and sustained increase in site-level trial expenses.