• Bridging the Gap Between GI Research and Routine Practice

    Clinical Research News | Gastroenterology is seeing meaningful progress in clinical research. New therapies for inflammatory bowel disease, colorectal cancer, and metabolic dysfunction-associated steatohepatitis (MASH) are being developed with increasing speed and precision. Yet for many community-based practices, participating in that research remains a significant challenge.

    Jun 6, 2025

  • Smart Bandage Technology Advances from Animal Models to Human Clinical Testing

    Clinical Research News | California Institute of Technology researchers have successfully transitioned their innovative "smart bandage" technology from preclinical animal studies to human clinical testing, marking a significant milestone in the development of real-time wound monitoring systems for chronic wound management.

    Jun 4, 2025

  • Many Approaches Collectively Aim at a Cure for Myeloma

    Clinical Research News | A small not-for-profit organization has set itself up as a model for turning the nitty-gritty of scientific research into a metaphorical “black swan event” with major impact on the lives of patients living with an incurable disease. The overarching strategy of the International Myeloma Foundation (IMF) is to function as the convener of the broader myeloma community in ways that lead to improved outcomes for patients in terms of both their quality and quantity of life.

    Jun 3, 2025

  • Follow the Money: PhaseV’s AI for Holistic Solutions, Carta’s AI Platform Transforms Clinical Data, More

    Clinical Research News | PhaseV intends to grow its vertical AI platform to provide holistic solutions for clinical development; Carta Healthcare is expanding to meet the surging demands among health systems and life sciences organizations for AI-driven innovation that can transform clinical data into valuable insights; and more.

    May 30, 2025

  • Weill Cornell, Regeneron’s New AI, Elsevier Adds Half a Million Records, More

    Clinical Research News | Weill Cornell Medicine and Regeneron Pharmaceuticals collaborated to develop a new AI-based method accurately sorts cancer patients into groups that have similar characteristics before treatment and similar outcomes after treatment; Elsevier announced the addition of half a million records from ClinicalTrials.gov to its leading biomedical literature database, Embase; and more.

    May 29, 2025

  • SCOPE 2025 Names West Clinical Research, Stitch as Site Innovation Award Winners

    Clinical Research News | West Clinical Research (WCR) and Stitch were named the Site Innovation Award winners at this year’s SCOPE Summit in Orlando. The Site Innovation Award at SCOPE recognizes sites and partnerships pioneering new approaches to improve clinical trials. WCR and Stitch’s collaboration produced a platform, also called Stitch, that is designed to optimize trial participants’ experiences while also improving other aspects of trial participation and for site staff labor.

    May 23, 2025

  • Multi-Center Study Validates AI Tools for Precision Cancer Diagnostics

    Clinical Research News | A clinical research initiative has demonstrated that artificial intelligence could significantly enhance the identification of patients eligible for targeted breast cancer therapies, according to preliminary findings presented by Friends of Cancer Research.

    May 21, 2025

  • The Scope of Things: Tackling Misinformation, Updated Guidelines to Clinical Trial Reports, More

    Clinical Research News | This month at the Scope of Things, host Deborah Borfitz gives you the latest news on a precision medicine initiative in Sweden integrating research with healthcare, guideline updates on the reporting of clinical trials, and more. Briony Swire-Thompson, director of the Psychology of Misinformation Lab at Northeastern University Network Science Institute, also joins in to discuss the current misinformation epidemic and how clinical trials and sites can best deal with it.

    May 20, 2025

  • Solving Patient Recruitment: Privacy Protection, Data Standardization, More

    Clinical Research News | Patient recruitment remains a “never-ending challenge." Despite efforts to leverage real-world data to alleviate the difficulties, there has not been a surefire solution. During April’s Bio-IT World Conference & Expo, panelists gathered to discuss the roots of the problem and share ideas that could potentially solve this issue.

    May 15, 2025

  • AI Platform Could Aid Precision Dosing for Multiple Conditions

    Clinical Research News | Given information on two blood biomarkers, together with drug type and dose, artificial intelligence (AI) was used to create personalized “digital twins” of cancer patients in an interventional clinical trial at a pair of Singapore hospitals. The goal was to “optimize only their own doses, dynamically."

    May 13, 2025

  • The Path To TMF Inspection-Readiness

    Clinical Research News | Regulators are tightening their scrutiny of the trial master file (TMF), placing the onus on companies to be ready for evaluation. Inspection-readiness should be embedded from the beginning, rather than a reaction to a notice of an inspection.

    May 9, 2025

  • ALS Research Getting a Big Boost from Open Science Initiative

    Clinical Research News | A diagnosis of amyotrophic lateral sclerosis (ALS) is devastating news given to about 5,000 people in the U.S. each year. It is a rare central nervous system disease without a cure that relentlessly progresses, although death variably occurs anywhere from a few months to many years after symptoms first become noticeable.

    May 8, 2025

  • Joan Chambers on the Impact of Decentralized Clinical Trials

    Clinical Research News | At last month’s Bio-IT World Conference & Expo, Joan Chambers, Senior Consultant at Tufts Center for the Study of Drug Development (CDSS), spoke extensively about the future of clinical trials, particularly on the impact of decentralized clinical trials (DCTs), approaches that improve accessibility and convenience for the trial process, and insights on solutions for patient recruitment and retention.

    May 6, 2025

  • Mayo Clinic New Research, BioProcess360’s New Biotech Company, Flatiron Health, Massive Bio Partnership, More

    Clinical Research News | FYR announced a collaboration with Mayo Clinic seeking to advance the use of blood-based biomarkers in Parkinson’s disease research and clinical applications; BioProcess360 Partners announced the formation of ChromaGenix, a new biotechnology company focused on advancing downstream purification technologies for emerging biotherapeutics; Flatiron Health announced a strategic partnership with Massive Bio to expand patient identification capabilities and improve clinical trial enrollment across the US; and more.

    Apr 30, 2025

  • Follow the Money: AIRNA’s RNA Editor, Rare Disease Trial, More

    Clinical Research News | AIRNA will further develop its AIR-001 to address AATD by targeting and repairing the SERPINA1 mutation in the RNA transcript; Glycomine will advance its lead candidate, GLM101, into a Phase 2b clinical trial for a rare and life-threatening genetic disorder with no approved treatments; and more.

    Apr 29, 2025

  • Patient-Focused Clinical Trial Design Using Net Treatment Benefit

    Clinical Research News | Pharmaceutical companies and regulators are increasingly aligning around the need to better incorporate patient preferences into clinical trial design. This shift stems from a broader movement to measure whether treatments are efficacious on terms that are also valuable from the patient’s perspective.

    Apr 25, 2025

  • Rethinking the Role of Nonprofits in the R&D Ecosystem

    Clinical Research News | Pharma companies and academic institutions are key players in drug development but operate in disconnected ecosystems. Universities are constantly developing highly innovative drug screening models, while industry has many promising molecules and drug compounds, yet the two worlds more often collide than collaborate to get needed medicines to patients faster.

    Apr 24, 2025

  • New Research Identifies Superior Biomarker for Stroke and Dementia Risk

    Clinical Research News | Researchers have identified "left atrial reservoir strain" as the best biomarker for predicting stroke and dementia risk, according to a new study published in the journal Stroke. The research, led by Dr. Lin Yee Chen of the University of Minnesota Medical School, compared various methods of detecting left atrial (LA) myopathy, an abnormality of the heart's left atrium that can indicate elevated risk even without atrial fibrillation (AFib).

    Apr 23, 2025

  • Precursors to Empowering QARA Professionals with AI-Driven Technologies

    Clinical Research News | As life sciences companies increasingly embrace artificial intelligence and digital transformation, quality assurance and regulatory affairs professionals face opportunities and challenges. The journey from paper-based systems to AI-driven solutions requires careful consideration of the various factors required to ensure successful implementation while maintaining global compliance and product quality to ensure the provision of safe and effective patient solutions and treatments.

    Apr 18, 2025

  • Vision Set for Integration of Research and Healthcare in Sweden

    Clinical Research News | Understanding the trajectory of a disease, including how it developed in the first place, is a bit like reconstructing a crime scene where scientists piece together fragmented information in hopes of mapping out the sequence of events and identifying the culprit. But critical connections can be made by analyzing multi-omics data linked to disease and registry data and turning them into actionable insights at the point of care.

    Apr 15, 2025