By Clinical Research News Staff

September 30, 2026 | Alliance trial finds fractionated radiosurgery reduces recurrence after brain metastasis surgery; FDA clears CU Anschutz CAR T-cell trial for colorectal cancer; Syneos Health and Tufts CSDD study links trial performance to operating model design; and more.

The Alliance for Clinical Trials in Oncology announced results from the randomized Alliance A071801 trial showing that fractionated radiosurgery after surgery for large brain metastases reduced cancer recurrence compared with single-session radiosurgery. The trial enrolled 242 patients from 2019 to 2022 who had one to four brain metastases, with at least one larger than 2 cm surgically removed. At one year, 87% of patients who received fractionated treatment over three to five sessions were free of recurrence at the surgical site, compared with 81% of those who received a single session. Median overall survival was 29 months versus 20 months, and fractionated treatment was associated with a 31% lower risk of death, with no significant difference in adverse events. Press release.

AINGENS released an analysis arguing that medical affairs teams using separate tools for literature search, drafting, citations, and review face governance and audit-trail challenges as AI adoption grows. The release cites Gartner projections that the average global Fortune 500 enterprise will use more than 150,000 AI agents by 2028, up from fewer than 15 in 2025, and that only 13% of organizations report having the right AI-agent governance in place. AINGENS positions its MACg (Medical Affairs Content Generator) platform as a single environment for medical affairs content development, covering real-time PubMed search, literature summarization, evidence gathering, drafting, automatic citations, reference management, editing, collaboration, and presentation building. Press release.

Veeva Systems introduced Veeva Study Builder Agent, an AI tool that configures Veeva EDC and Veeva DQS directly from a study protocol, with the aim of completing study builds in as little as one day. The agent configures EDC forms, visits, and edit-check rules, along with CQL-based listings in DQS, and generates test data and runs automated testing to produce audit-ready builds. It draws on a customer's existing standards and the CDISC Unified Study Definitions Model (USDM) to minimize deviation from those standards. Study Builder Agent is delivered as a Claude Cowork plugin installed from a Veeva-managed GitHub repository and is included with Veeva EDC at no additional license cost. It will be available to early adopters in December 2026. Press release.

Helix announced the launch of Helix Research Workspaces, a trusted research environment built with Databricks on the Databricks Data + AI platform. The environment gives approved Helix research partners secure access to more than 550,000 GenoSphere clinicogenomic records, which combine Exome+ genomic data with an average of more than 13 years of electronic health records, enriched with medical and pharmacy claims. Features include a custom toolkit for population-scale genomic analysis, built-in AI-assisted coding, project-based collaborative notebooks with data access controls, and real-time visibility into analysis progress and compute costs. Research Workspaces extends Helix's Cohort Builder, launched earlier in 2026, which lets users build cohorts through a graphical interface or AI-assisted natural-language search. Press release.

The National Institutes of Health (NIH) launched Linked Discoveries, an experimental public tool developed by the National Library of Medicine's National Center for Biotechnology Information that shows how individual research findings connect to the broader biomedical evidence base. The tool is part of an agency-wide initiative to strengthen replication and reproducibility in NIH-funded research. It covers more than 29 million PubMed publications and is accessible from PubMed citations. An AI-informed method identifies each article's network of closely related publications, including replication studies, displayed in graph and timeline views with filters for conditions, genes, and chemicals. The tool does not assess study quality or confirm whether a replication succeeded. The National Library of Medicine will continue refining it based on user feedback. Press release.

Vanderbilt Health received a federal contract of up to $11.2 million over five years to establish and run the Goldilocks Program, a clinical trials acceleration platform for critical illness within the Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE) program funded by ARPA-H. The program aims to shorten testing of new technologies from the typical 12 to 18 months to under 90 days by assessing technologies in simulated and real-world ICUs, supporting pilot studies, running adaptive clinical trials, and generating evidence for regulatory review and commercial adoption. The effort will draw on a network of up to 25 institutions and more than 100 ICUs across the U.S. and will be led by Wesley Self, MD, MPH. Press release.

Novadip Biosciences secured €10.4 million in convertible financing led by New Science Ventures, with participation from Fund+, Wallonie Entreprendre, VIVES Fund, ORSA Tech, Sambrinvest, Noshaq, and Invest.BW, bringing its total convertible financing since June 2025 to €20 million. The round also unlocks the final tranche of an €18 million venture-debt facility from the European Investment Bank. The Belgian company will use the funds to complete its pivotal Phase 3 trial of NVD003, an autologous cell therapy for congenital pseudarthrosis of the tibia, and to prepare a U.S. Biologics License Application, with market entry targeted for 2028. Its pipeline also includes NVDX3, an allogeneic bone-grafting material for which FDA has cleared a Phase 2b/3 trial. Press release.

London Health Sciences Centre Research Institute (LHSCRI) announced a clinical trial testing whether fecal microbiota transplant (FMT) capsules can help people with anorexia nervosa, conducted with Lawson Research Institute of St. Joseph's Health Care London and Western University. The study is recruiting 20 participants aged 16 to 35 with restricting-type anorexia nervosa who are not hospitalized or in active cognitive behavioral therapy. Participants will take the capsules, complete questionnaires, and provide stool samples before and several times after the intervention. Lawson's FMT team screens healthy donors and processes the stool into tasteless, odorless pills. The research team includes LHSCRI psychiatrist Elizabeth Osuch, MD, and the study is funded by the Academic Medical Organization of Southwestern Ontario. Press release.

UVA Health announced that University of Virginia researchers received the first $4 million tranche of an award worth up to $12 million from the National Institutes of Health to develop MOSAIC (Modeling of Sex-specific metabolism Across Interacting Communities), an open-source digital model of how hormonal differences between men and women can affect the effectiveness of some medications. The model will simulate interactions among women's gut, liver, and reproductive systems, including how gut bacteria influence estrogen levels. NIH's Office of Research Innovation, Validation, and Application provided more than $4 million in co-funding. Jason Papin, PhD, leads the project with collaborators at Johns Hopkins University, the University of Connecticut, the University of Michigan, and the University of Illinois Chicago. Press release.

Condor Software launched a clinical finance AI agent for biopharma R&D that explains the drivers behind budget-versus-forecast variances, runs what-if scenario modeling, and builds the resulting forecasts within the Condor platform. The agent addresses the hours or days teams spend reconciling data across ERP, CTMS, and EDC systems and spreadsheets. Using Condor's proprietary knowledge graph and a deterministic math layer, it answers questions such as which underperforming sites are affecting budget, timeline, and enrollment, what it will cost to complete enrollment, and what is driving rising change orders. The agent is part of Condor AI Workflows, one of three Condor products alongside Connect and AI Insights. Customers include Acadia Pharmaceuticals, BridgeBio Pharma, Madrigal Pharmaceuticals, and Stemline Therapeutics. Press release.

The Advanced Research Projects Agency for Health (ARPA-H) launched SPECTRA (Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency), a program to change how autism is understood, diagnosed, and supported across the lifespan. SPECTRA will combine biological, clinical, behavioral, and real-world data with computational tools to support earlier diagnosis and individualized care. The program has four focus areas: analysis of genetic, environmental, metabolic, immune, and developmental factors; federated AI platforms that model clinical trajectories; selection and testing of individualized interventions; and accessible communication and assessment tools. About 1 in 31 U.S. 8-year-olds have been identified with autism spectrum disorder, and autistic people face shorter average lifespans and higher risk of dementia and Parkinson's disease. Press release.

Texas Tech University Health Sciences Center (TTUHSC), working with Texas Tech University, received a $24.5 million, five-year grant from the National Institutes of Health, the largest NIH grant in the Texas Tech University System's history. The award is a U54 cooperative agreement, an NIH mechanism for large multidisciplinary research programs. The funds will support research capacity, mentorship, professional development, and community engagement across TTUHSC's 121-county service area, with an emphasis on medically underserved and rural populations. Research approaches will include population health data analyses, implementation science, health services research, and community-based participatory research. The principal investigators are Lance R. McMahon, PhD; Julie St. John, PhD, DrPH; and Naima Moustaid-Moussa, PhD. Press release.

Syneos Health and the Tufts Center for the Study of Drug Development (Tufts CSDD) released results of a benchmark study examining whether in-house, full-service CRO, or functional service provider (FSP) sourcing models affect clinical trial performance. The study, launched in 2025, analyzed data from 13 sponsor companies, 81 development programs, and 133 clinical trials. No single model consistently performed best on cycle times, site activation, recruitment, retention, or quality. Using more service providers was associated with longer times from protocol approval to database lock, higher dropout in some settings, and more protocol amendments and quality events. Performance depended instead on a fit-for-purpose operating model, alignment between sponsors and vendors on shared goals, and clear accountability. Press release.

Michigan State University researchers received a National Institutes of Health grant of $4.6 million initially, and up to $12.8 million over three years, to build computational models predicting how hormone changes affect drug effectiveness and side effects in women across menstrual cycles, pregnancy, birth control, menopause, and hormone replacement therapy. The award is part of NIH's $21 million Computational Modeling of Hormone Homeostasis Initiative. Led by Teresa K. Woodruff, the 13-member team includes researchers from Rutgers, Emory, Tulane, the University of Colorado Anschutz, the University of Michigan, and the University of Utah. Goals include using AI to digitize more than 40 years of hormone research data into a public database, and building personalized treatment tools for metformin, insulin, and GLP-1 drugs. Press release.

The University of Tokyo announced that Japan has approved sodium phenylbutyrate (Buphenyl) for a new indication, progressive familial intrahepatic cholestasis (PFIC) types 1 and 2, a rare liver disease affecting about 1 in 50,000 to 100,000 people that usually begins in infancy or childhood. Research led by Associate Professor Hisamitsu Hayashi of the Graduate School of Pharmaceutical Sciences found that the drug increases bile salt export pump protein on liver cells, allowing more bile acid to move into bile. An investigator-initiated trial in six children with PFIC type 2 at multiple Japanese hospitals showed the drug could slow liver damage. The team also established the CIRCLe patient registry. OrphanPacific supplied the drug and funding and filed the application. Press release.

The European Society for Medical Oncology (ESMO) launched the ESMO Clinical Trials Funding Initiative: Optimising Cancer Care Pathways to Improve Patient Outcomes, which will provide €1 million for academic clinical research. Academic institutions, cancer centers, hospitals, and cooperative research groups running interventional clinical trials may apply. The initiative supports pragmatic studies on treatment optimization and sequencing, simplified treatment delivery, de-escalation, alternative care pathways, patient-centered care, and healthcare sustainability. Studies may be recruiting, approved but not yet recruiting, or awaiting approvals. Applications will be assessed on scientific quality, potential to change practice, patient impact, sustainability, feasibility, and global relevance, and funded studies must meet requirements including public registration, data sharing, and patient involvement. The application deadline is November 1, 2026. Press release.

The University of Colorado Anschutz announced that the FDA has cleared its investigators to begin a clinical trial of an experimental CAR T-cell therapy developed at CU Anschutz for adults with advanced colorectal cancer and children with solid cancers who have exhausted standard treatment options. The therapy targets B7-H3, a protein found on most colorectal tumors, and IL-8, a protein that drives tumor growth, inflammation, and spread. The cells will be manufactured at the campus's Gates Biomanufacturing Facility. The trial, led by Christopher Lieu, MD, of the CU Anschutz Cancer Center, is expected to begin in December. If successful, the approach could later be tested in some breast, lung, and ovarian cancers. Press release.

CluePoints announced general availability of three AI-led clinical data review capabilities co-developed with a top-10 pharmaceutical company. Intelligent Query Detection replaces broad manual listing review with targeted query generation, letting data managers write their own review scenarios without code or vendor releases. Medical & Safety Review turns the ICH-GCP review requirement into a continuous, patient-centric workflow that consolidates data from multiple sources without mapping and builds an audit-ready record. Intelligent Medical Coding, an agentic deep-learning application that runs within Veeva Vault EDC, suggests MedDRA and WHODrug codes, with up to 99% accuracy for MedDRA and about 50% less manual coding effort. The tools are live in the vast majority of the partner's ongoing studies. Press release.