Drug Costs in Federally Sponsored Cancer Clinical Trials

Abstract

Importance  Federally sponsored cancer clinical trials (FS-CCTs) address research questions often overlooked by industry (eg, pharmaceutical or biotechnology companies), such as treatment combinations, rare cancers, within-class comparisons, and de-escalation strategies.

Introduction

Federally sponsored cancer clinical trials (FS-CCTs) address a broad spectrum of critical clinical cancer research questions often ignored by industry (eg, pharmaceutical or biotechnology companies), which primarily aims to receive new drug approvals and indications for existing therapeutic agents.

Methods

This systematic review used publicly available, trial-level aggregate data and did not involve human participants; accordingly, the need for study approval and informed consent were both waived by the Fred Hutchinson Cancer Center Institutional Review Board

Data Sources and Variables

Trials and Agent Attributes

We extracted trial and agent characteristics from ClinicalTrials.gov records and trial protocols, including drug names, dose strength and unit, number of treatment cycles, dosing frequency, route of administration (eg, oral, intravenous), and enrollment per agent. Additional trial-level characteristics, including trial phase, sponsors and collaborators,

Drug Price Components and Estimation Algorithm

Drug prices (hereinafter referred to as the wholesale acquisition cost [WAC] for a given drug) was obtained from a drug reference dataset (Micromedex Red Book; IBM Corporation18) by matching the product or active ingredient names and the administration route. Both current and historical WAC were included if the effective date of the list price fell within the trial’s study period

Statistical Analysis

Analyses were conducted between June 1 and September 20, 2025, using R version 4.4.1 (R Foundation for Statistical Computing). We derived estimates of both the planned and actual drug acquisition costs. Estimated planned total drug acquisition costs (hereinafter referred to as estimated costs) represent the anticipated total drug costs if all patients complete their protocol-specified full course of treatment.

Conclusions

In this systematic review of FS-CCTs, drug acquisition costs were substantial and highly variable, with higher costs in later-phase trials, trials involving immunotherapies or targeted agents, and federally sole-sponsored studies. These findings reflect the increasing complexity of oncology trials and the financial challenges of publicly funded research.

Article Information

Accepted for Publication: June 4, 2026.

Published: July 28, 2026. doi:10.1001/jamanetworkopen.2026.25814

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License, which does not permit alteration or commercial use, including those for text and data mining, AI training, and similar technologies. © 2026 Xiao H et al. JAMA Network Open.

Corresponding Authors: Hong Xiao, PhD (hxiao2@fredhutch.org), and Joseph M. Unger, PhD, MS (junger@fredhutch.org), Fred Hutchinson Cancer Center, 1100 Fairview Ave N, Mail Stop M3-C102, Seattle, WA 98109-1024.

Author Contributions: Drs Xiao and Unger had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Conflict of Interest Disclosures: Dr LeBlanc reported receiving grant support from the National Institutes of Health during the conduct of the study. Dr Unger reported receiving personal fees from Eli Lilly and Company and AstraZeneca outside the submitted work. No other disclosures were reported.

Funding/Support: This study was supported by the Public Health Sciences Division of Fred Hutchinson Cancer Center.