Researchers led by Joseph M. Unger, PhD, a biostatistician and health services researcher with the SWOG Cancer Research Network and a professor in the Public Health Sciences Division at Fred Hutch Cancer Center, examined records from ClinicalTrials.gov covering the period from 2008 through 2024. They included interventional trials that had opened at least one site in the United States. A trial was categorized as federally sponsored when a government agency, such as the National Institutes of Health, served as its lead sponsor. Studies led by pharmaceutical or biotechnology companies were classified as industry sponsored. Of the 11,681 trials that met the study criteria, 9,569, or 81.9 percent, were supported by industry.

The researchers found that the two funding sectors were not simply competing to conduct the same experiments. Instead, their portfolios appeared to occupy different positions within the cancer research ecosystem. Approximately 90 percent of all the trials analyzed listed cancer treatment as their primary purpose, but the nature of those treatments varied substantially by sponsor. Industry-backed studies were more likely to evaluate a single drug or biologic, a design that can efficiently determine whether a specific product is safe and effective enough to advance toward regulatory approval. Federally sponsored studies, by contrast, more often examined interventions that do not fit neatly into a single-product business model or require longer-term, system-wide evaluation.

This distinction reflects the economic and scientific realities of clinical research. A pharmaceutical company generally has a direct interest in generating definitive evidence for a particular compound, often through carefully controlled trials designed to support approval by the U.S. Food and Drug Administration. These studies may begin with very early phase I testing, which focuses primarily on safety, tolerability, dose escalation, and pharmacokinetics, before moving into larger phase III trials that compare the investigational treatment with an established standard. The analysis showed that industry trials were especially common at these two ends of the development pathway: very early phase I studies and later phase III trials. Federally supported studies were more frequently phase II investigations, a stage often focused on detecting preliminary antitumor activity and refining how a treatment should be used.

Federal trials were also much more likely to investigate treatment de-escalation. Such studies ask whether patients can receive less therapy without losing the benefits of treatment. A de-escalation trial might test a lower dose, a shorter course, fewer treatment cycles, or a less intensive combination of therapies. These questions are increasingly important as cancer survival improves and clinicians seek to reduce long-term toxicity, infertility, organ damage, cognitive effects, and the financial burden of care. Yet de-escalation can be difficult to commercialize because its central outcome may be the safe reduction of treatment rather than the introduction of a new product. Public funding is therefore often essential for answering whether “less” can be just as effective as “more” for carefully selected patients.

The federal portfolio also showed a greater emphasis on multimodality treatment, in which several forms of therapy are integrated into a single strategy. These approaches may combine systemic drugs with surgery, radiation, transplantation, immunotherapy, or other interventions. A trial might, for example, evaluate chemotherapy before surgery, followed by radiation and targeted maintenance treatment, while measuring not only tumor control but also surgical complications, quality of life, and long-term survival. Such protocols are scientifically complex because their results depend on timing, sequencing, patient selection, and coordination across multiple specialties. They may also involve several products or procedures owned by different organizations, making them less attractive as conventional industry-led studies.

Non-drug interventions were another major area in which federally supported research was more prominent. These trials included surgery, transplantation, behavioral interventions, screening strategies, diagnostics, health services research, cancer prevention, and supportive care. The technical importance of these studies is substantial: cancer outcomes are determined not only by the biological activity of a drug but also by how early disease is detected, whether patients can access treatment, how symptoms are managed, and whether evidence-based care is delivered consistently. Diagnostic trials can evaluate biomarkers that predict response or resistance, while health services studies may examine disparities, treatment delays, adherence, and the performance of care systems across different communities.

Federally sponsored trials were also considerably more likely to address childhood cancers and rare cancers, including diseases with fewer than 40,000 diagnoses in the United States each year. Small patient populations create a fundamental challenge for clinical research. A rare cancer may have too few potential participants to support a conventional commercial strategy, even when the disease represents a serious unmet medical need. Pediatric cancers pose additional challenges because treatment must be evaluated in developing bodies, with attention to lifelong effects that may appear decades after therapy. Publicly supported networks can assemble patients across institutions, standardize protocols, and maintain research infrastructure for conditions that would otherwise struggle to attract sustained investment. The study found that the gap between federal and industry participation in rare-cancer trials narrowed over the period examined, suggesting that private-sector interest in some underserved diseases may be growing.

Despite their distinctive role, federally sponsored studies represented a much smaller share of the national clinical-trial portfolio. The authors estimate that, compared with federally supported trials, roughly nine out of every ten participants enrolled in industry-sponsored cancer trials. This imbalance has implications beyond funding statistics because the questions asked in clinical trials determine which forms of evidence become available to doctors and patients. If industry continues to concentrate on commercially promising single-agent drugs, important questions about prevention, supportive care, treatment combinations, de-escalation, access, and implementation may receive less attention. Unger and his colleagues describe the relationship between the sectors as complementary: federal research often contributes foundational science, trial infrastructure, and early efficacy studies, while industry frequently leads the large, late-stage trials that establish whether a treatment can achieve regulatory approval. After approval, federally supported investigators may then test the drug in combinations, different disease settings, or treatment plans involving surgery and radiation.

The researchers caution that this complementary model should not be mistaken for a guarantee that every clinically important question will be answered. Public funding must support the infrastructure required to conduct independent, technically demanding trials, while industry participation remains critical for translating promising discoveries into approved therapies and widely available products. The findings point toward a cancer research system in which neither sector can fully replace the other. Industry resources can accelerate drug development, but federal investment is often needed to study questions whose benefits are broadly shared, difficult to monetize, or relevant only to small patient populations. The analysis was supported by the Public Health Sciences Division of Fred Hutch Cancer Center and The Hope Foundation for Cancer Research. In addition to Unger, the study team included Hong Xiao, PhD; Michael L. LeBlanc, PhD; and Dawn L. Hershman, MD, MS.

Subject of Research: Cancer clinical trials and sponsorship patterns

Article Title: Federal and Industry Sponsorship in US Cancer Clinical Trials

News Publication Date: 20-Aug-2026

Web References: https://doi.org/10.1001/jamaoncol.2026.3026

References: Unger JM, Xiao H, LeBlanc ML, Hershman DL, et al. “Federal and Industry Sponsorship in US Cancer Clinical Trials.” JAMA Oncology, published online August 20, 2026. DOI: 10.1001/jamaoncol.2026.3026

Keywords: cancer research, clinical trials, federal funding, industry funding, pharmaceutical research, oncology, cancer drug development, rare cancers, pediatric cancers, treatment de-escalation, multimodality therapy, health services research, clinical research policy

The ACS BrightEdge Entrepreneurs Program offers participating startups financial resources, including a $100,000 SAFE (Simple Agreement for Future Equity) investment funded by the ACS BrightEdge Investment Fund. This financial backing is supplemented by extensive mentorship opportunities and tailored educational modules designed to enhance startups’ commercialization strategies, sharpening their skills to move potentially groundbreaking innovations from lab bench to bedside efficiently. Being selected in this competitive environment is a testament to Dr. O’Raw’s pioneering work and entrepreneurial acumen.

Dr. O’Raw’s focus with OnVagus, the biotechnology venture she co-founded, targets one of oncology’s most devastating complications—cancer-associated cachexia. Cachexia is a complex metabolic syndrome characterized primarily by muscle wasting, severe weight loss, anorexia, and systemic inflammation. Despite its prevalence, affecting approximately 80% of cancer patients and accounting for over one-third of cancer-related deaths, cachexia remains incurable. OnVagus is advancing a novel, non-invasive therapeutic approach that leverages the gut-brain axis to combat this syndrome, offering hope for vastly improved patient quality of life and survival rates.

The science underlying OnVagus’ innovation is built on harnessing bioelectronic medicine principles where modulation of the vagus nerve, a critical component of the autonomic nervous system, can influence metabolic and inflammatory pathways. By stimulating this nerve non-invasively, the device aims to reverse the pathological features of cachexia observed in preclinical studies, including mitigation of muscle atrophy and chronic systemic inflammation. This approach sidesteps traditional pharmacological interventions, eliminating the need for drugs, needles, or surgery, thus minimizing potential side effects and improving patient compliance.

Dr. O’Raw highlighted the significance of her selection, emphasizing the strategic advantage the ACS BrightEdge Entrepreneurs Program presents to OnVagus. The program’s mentorship network comprises seasoned experts who bring diverse perspectives, from clinical oncology to biomedical engineering and venture investment. This cross-disciplinary support is vital for refining the technology’s commercialization pathway and accelerating OnVagus’ entrance into human trials, scheduled for the second quarter of 2026. The ultimate goal is clear: deliver an effective cachexia therapy that can be seamlessly integrated into oncology care.

Stewart Han, President of the Terasaki Institute for Biomedical Innovation, expressed enthusiastic support, underscoring that Dr. O’Raw’s achievement aligns with TIBI’s core mission of translating cutting-edge biomedical research into practical clinical solutions. The institute prioritizes projects that offer clear translational potential and patient-centric benefits, as evidenced by OnVagus’ innovative mechanism and therapeutic promise. Han remarked that the ACS program will provide crucial infrastructure and resources enabling investigators like Dr. O’Raw to surmount commercialization challenges that frequently inhibit medical breakthroughs.

The ACS BrightEdge Entrepreneurs Program itself represents a vital mechanism for nurturing early-stage companies developing cancer-related technologies. These companies often face high barriers, including regulatory complexities, funding gaps, and operational challenges related to studying intricate biological systems such as cancer cachexia. By offering a structured program culminating in a closed pitch event before a network of investors, ACS promotes scalable innovation with real-world impact potential, catalyzing solutions that might otherwise languish in preclinical or early clinical development stages.

OnVagus’ approach uniquely targets the gut-brain axis, which has garnered increasing interest in recent years for its role in systemic diseases. This bi-directional communication system allows the central nervous system to modulate inflammation, appetite, and energy metabolism—pathways profoundly disrupted in cachexia. By employing a wearable or portable device that non-invasively stimulates the vagus nerve, OnVagus taps into this neurophysiological circuit to recalibrate systemic responses, effectively combating wasting and improving patient anabolic states.

Preclinical models have demonstrated that this vagus nerve stimulation can substantially reverse cachexia’s hallmarks, such as muscle degradation, anorexia, and heightened inflammatory markers. These results provide pivotal proof-of-concept evidence supporting clinical trial advancement. Furthermore, the non-invasive nature of the therapy offers significant advantages over invasive neuromodulation approaches, which typically require implanted devices with associated surgical risks.

From a biomedical engineering perspective, developing such a neurostimulation device involves overcoming challenges including precise targeting of the vagus nerve, ensuring consistent stimulation parameters, and integrating user-friendly interfaces suitable for cancer patients whose health statuses are compromised. OnVagus’ team combines expertise in bioengineering, neurobiology, and clinical oncology, fostering a multidisciplinary environment conducive to innovation and rapid problem-solving.

The upcoming clinical trial phase represents a critical milestone, as OnVagus will evaluate safety, tolerability, and preliminary efficacy in human subjects. Success in clinical trials would pave the way for broader adoption, potentially establishing a new standard of care for cachexia management. By providing patients with a treatment option that alleviates one of cancer’s deadliest complications, OnVagus aims to extend survival curves and enhance the overall therapeutic experience.

Dr. O’Raw’s involvement in the ACS BrightEdge Entrepreneurs Program also exemplifies the increasing trend of researchers embracing entrepreneurship to propel healthcare innovations. Bridging the gap between academic research and commercial application is crucial in translating scientific discoveries into tangible patient benefits. Programs like BrightEdge empower investigators with the training, network, and capital required to navigate this complex journey successfully.

In conclusion, Dr. Aliesha O’Raw’s selection for this esteemed program marks a pivotal step forward in cancer cachexia research and treatment development. Through OnVagus’ groundbreaking approach harnessing vagus nerve stimulation, there is renewed hope for millions of cancer patients battling cachexia worldwide. The collaboration between the ACS, Terasaki Institute, and entrepreneurial innovators like Dr. O’Raw underlines the essential synergy between science, engineering, and business needed to conquer cancer’s multifaceted challenges.

Subject of Research: Cancer-associated cachexia and neurostimulation-based therapeutic interventions
Article Title: Terasaki Institute’s Dr. Aliesha O’Raw Selected for ACS BrightEdge Entrepreneurs Program to Transform Cancer Cachexia Treatment
News Publication Date: March 17, 2026
Web References: https://mediasvc.eurekalert.org/Api/v1/Multimedia/9449d286-4f4e-4396-b4f6-4f36a1d2bddc/Rendition/low-res/Content/Public
Image Credits: Terasaki Institute
Keywords: Cancer research, Oncology, Biomedical engineering, Biotechnology, Cancer-associated cachexia, Neurostimulation, Vagus nerve, Bioelectronic medicine, Cancer therapeutics, Translational research