Phase I Lung Cancer Trials Consolidate at Major U.S. Medical Centers, Raising Access Concerns
核心洞察
The number of unique U.S. sites conducting phase I non-small cell lung cancer (搜索) trials decreased by 44% between 2020 and 2024, dropping from 395 to 223 locations.
Trial activity became increasingly concentrated at the top 20 highest-volume sites, which are predominantly located in major cities with populations exceeding 1.9 million.
This consolidation trend conflicts with FDA efforts to decentralize clinical trials and may limit patient access to experimental treatments.
A comprehensive analysis of phase I clinical trials for non-small cell lung cancer (搜索) (NSCLC (搜索)) reveals a troubling trend toward consolidation at major U.S. medical centers, potentially limiting patient access to experimental treatments. Between 2020 and 2024, the number of unique sites conducting these early-stage trials decreased by 44%, from 395 to 223 locations, according to research presented at the American Association for Cancer Research (搜索) Annual Meeting 2026.
The findings come at a time when the FDA's Oncologic Drug Advisory Committee (搜索) has raised concerns about insufficient U.S. patient enrollment and underrepresentation in clinical trials, even voting against drug approvals due to questions about trial population representativeness.
Geographic Concentration Intensifies
The study, led by Brittany Avin McKelvey, PhD, senior director of regulatory policy at LUNGevity Foundation, examined all interventional, industry-sponsored phase I NSCLC (搜索) trials listed on ClinicalTrials.gov during the study period. The analysis revealed that while overall trial sites declined dramatically, the top 20 highest-volume sites maintained stable activity, with a median of seven to 11 trials opening annually at each location.
These top-performing sites are predominantly located in major metropolitan areas with average populations exceeding 1.9 million, creating a geographically concentrated clinical trial landscape that may result in more limited access for patients in smaller communities.
"It is imperative that clinical trial populations reflect as closely as possible the end-user population to sufficiently determine a therapy's safety and efficacy and inform its optimal use," McKelvey said. "Therefore, a better understanding of where clinical trials are being conducted, and how the participation of trial sites changes over time, can ensure that we support policies that encourage representativeness and applicability of trial results to the U.S. population."
Global Trends Mirror U.S. Patterns
The consolidation trend extends beyond U.S. borders. During the study period, 555 trials opened across 47 countries, generating 8,393 trial instances. While the United States maintained the largest share at 45%, followed by China (11%), Spain (8%), Korea (5%), France (4%), and Australia (4%), most countries experienced declining trial activity.
U.S. trial instances initially increased from 819 in 2020 to 955 in 2022 before declining sharply to 566 by 2024. Similar patterns emerged globally, with China dropping from 196 to 95 instances, Spain from 105 to 80, Korea from 80 to 66, and France from 48 to 47. Only Australia (64 to 76), Japan (32 to 49), and Brazil (9 to 29) showed considerable increases.
Complex Factors Drive Consolidation
McKelvey identified several factors contributing to this consolidation. Phase I trials increasingly feature complex protocols, and the safety profiles of new oncology modalities create substantial infrastructure and expertise requirements that may be prohibitive for smaller sites. Additionally, increased regulatory and compliance burdens associated with initiating and conducting trials serve as barriers for smaller institutions.
"The competitive oncology landscape for trial enrollment may favor established sites with proven track records, creating a self-reinforcing cycle where high-performing sites attract more trials, develop greater expertise, and become increasingly preferred by sponsors—while lower-volume sites struggle to maintain the infrastructure and expertise needed to compete for trials," McKelvey explained.
NCORP Sites Show Resilience
However, the data revealed an important exception to the consolidation trend. Low-volume sites participating in the National Cancer Institute Community Oncology Research Program (搜索) (NCORP (搜索)) largely maintained their trial instances over the observed period, compared with other low-volume sites.
"This could suggest that the infrastructure support and integration into research networks at NCORP (搜索) sites may be able to buffer these community sites against the factors driving consolidation," McKelvey noted.
Policy Implications and Future Directions
The findings directly conflict with FDA efforts to decentralize clinical trials and move them into community settings. McKelvey emphasized that addressing this consolidation will require coordinated efforts to reduce site activation barriers, provide infrastructure support, and potentially implement policy incentives that encourage diversification of trial portfolios within the United States.
"Our analysis showed a concerning trend towards trial consolidation at top-performing sites in the United States, further affirming concerns raised at the recent FDA ODAC (搜索) meetings about site saturation and conflicting with the agency's appeals to decentralize and move trials into the community," McKelvey said.
The research team acknowledges several limitations, including the heterogeneity of ClinicalTrials.gov data and the focus on NSCLC (搜索) phase I trials, which may not fully represent patterns in other cancer types or later-phase studies. McKelvey indicated that her team is considering studies on later-phase clinical trials, which may allow for broader participation by less experienced sites given their known safety profiles.