Drug Costs in Federally Sponsored Cancer Clinical Trials: A Systematic Review
Hong Xiao1, Michael L LeBlanc1, Monica M Bertagnolli2
1Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, Washington.
JAMA Network Open
|July 28, 2026
Summary
Federally sponsored cancer clinical trials (FS-CCTs) incur substantial drug costs, especially for immunotherapies and targeted agents in late-stage studies. These high expenses necessitate industry partnerships, potentially impacting research independence and innovation.
Area of Science:
- Oncology
- Health Economics
- Clinical Trial Management
Background:
- Federally sponsored cancer clinical trials (FS-CCTs) investigate critical research areas not typically addressed by industry sponsors.
- Quantifying drug costs in FS-CCTs is essential for policy development and optimizing federal support for cancer research.
- Federal agencies often do not cover drug costs, requiring cosponsorship or donations, which can complicate trial initiation.
Purpose of the Study:
- To estimate the direct drug purchase costs within FS-CCTs.
- To analyze drug cost patterns based on sponsor type and therapeutic class.
Main Methods:
- Systematic review of US-based cancer treatment trials initiated between 2017 and 2023 from ClinicalTrials.gov.
- Inclusion criteria: pharmaceutical or biological interventions and federal sponsorship.
- Cost estimation based on wholesale acquisition costs; statistical analysis using Mann-Whitney and Kruskal-Wallis tests.
Main Results:
- Median trial-level drug costs were $7.58 million, significantly higher in Phase 3 ($58.92M) vs. early-phase trials ($6.90M).
- Immunotherapies ($9.25M), targeted therapies ($6.60M), and combination therapies ($15.08M) were more costly than chemotherapy ($0.43M).
- Experimental agents comprised ~80% of total drug costs; per-patient costs were higher in solely federally funded trials.
Conclusions:
- Drug costs in FS-CCTs are substantial, particularly for advanced therapies and late-stage trials.
- High drug costs frequently necessitate industry collaboration, potentially limiting trial independence and hindering novel treatment discovery.
- Policy adjustments are needed to alleviate the financial burden of trial drugs and support independent cancer research.
Related Concept Videos
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:21Cancer Survival Analysis
Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...
01:12Hazard Ratio
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial evaluating a...
For example, in a clinical trial evaluating a...
02:56Treatment Resistent Cancers
Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
02:49Cancer Therapies
Cancer therapies are various modes of treatment, such as surgery, radiation therapy, and chemotherapy that are administered to cancer patients.
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...