• The Invisible Infrastructure: Bio-IT World Panel Warns of a Slow-Motion Crisis in Biomedical Data

    Clinical Research News | At last month's Bio-IT World Conference & Expo, Douaa Mugahid, PhD, Data Officer at the Hi-IMPAcTB Consortium at the Harvard School of Public Health moderated a panel of academics, investors, and consultants to take on the future of public data and software infrastructure. It is time to safeguard publicly funded data infrastructure, which underpins virtually all of modern biomedical research.

    Jun 17, 2026

  • A Simple Swab Could Change How Doctors Detect Endometrial Cancer

    Clinical Research News | For the roughly 1.3 to 2 million women who visit their doctor each year with abnormal postmenopausal bleeding, the diagnostic journey has long been an uncomfortable one. The standard workup typically involves an endometrial biopsy—an invasive, often painful procedure that, despite its widespread use, fails to yield a conclusive diagnosis in more than 30% of cases. Two veteran diagnostics executives think there's a better way, and they're betting nearly $45 million in venture funding on it.

    Jun 16, 2026

  • Urine Liquid Biopsy Shows Strong Promise for Guiding Bladder Cancer Treatment — Clinical Trials on the Horizon

    Clinical Research News | A novel urine-based liquid biopsy developed at Stanford University is showing remarkable accuracy in predicting bladder cancer recurrence and may soon reshape how clinical trials enroll and treat patients. The test, developed by urologic oncologist Joseph Liao, M.D., and colleagues, filters out age-related background mutations in urine to produce a cleaner, more reliable signal for detecting residual cancer after surgery and immunotherapy.

    Jun 11, 2026

  • The Scope of Things: Measuring Equity in Cancer Care

    Clinical Research News | In the latest episode of The Scope of Things, Eugene Manley, Jr., founder and CEO of the STEMM & Cancer Health Equity Foundation, explains how underrepresented populations, including Black, Hispanic, Indigenous, rural, low-income, immigrant, underinsured, and uninsured communities, are less likely to receive guideline-aligned biomarker testing and less likely to be asked about clinical trial participation at all.

    Jun 9, 2026

  • Regulatory Outlook in Diagnostics Innovative and Uncertain

    Clinical Research News | The diagnostics industry is at the intersection of enormous clinical development and technological change, enabling first-ever detection milestones heavily driven by artificial intelligence and multi-biomarker tests. But it has increasingly been coming into conflict with a decades-old regulatory system that didn’t anticipate these technological changes and a political environment that favors U.S. competition and innovation but is also interested in cutting the budget.

    Jun 4, 2026

  • A ‘Credit-Score-Like’ Risk Assessment System for Investigative Drugs

    Clinical Research News | VeriSIM Life is building the “full-stack predictive infrastructure” to help pharma companies foresee the challenges ahead in translating a molecule from laboratory discovery to a successful human therapy. The help comes in the form of a dynamic, “credit-score-like” assessment of the risk with inherent explainability and trust.

    Jun 3, 2026

  • Phesi Highlights Disconnect Between Protocols and Outcomes, Warns of AI Repetition

    Clinical Research News | An analysis released by Phesi suggests that the systematic use of historical protocol templates without using patient data and context to guide protocol design leads to flaws being scaled, rather than solved, by AI.

    Jun 2, 2026

  • Flatiron’s AI-Powered Platform, Verana Health Ovarian Cancer Database, Eir Partners Invests in QuartzBio

    Clinical Research News | uMotif launches its new Scientific Consulting Services; Veeva Systems announces Veeva Falcon; b.well Connected Health and myTomorrows announce a partnership; and more.

    May 29, 2026

  • Insider Views on the FDA’s Evolving Relationship with AI

    Clinical Research News | The Food and Drug Administration is undergoing a major step change in how it regulates and evaluates drugs, marked by a shift toward real-time clinical trials, an agency-wide rollout of generative AI tools to speed up drug application reviews, and a radical transparency push that includes public disclosure of complete response letters sent to pharmaceutical companies explaining why a drug application was rejected.

    May 27, 2026

  • Follow the Money: AI Drug Design Engine Development, Multiple Myeloma Trials, More

    Clinical Research News | Isomorphic Labs continues to develop its AI drug design engine; CellCentric advances in multiple myeloma; and more.

    May 26, 2026

  • Data is Both the Fuel and Downfall of AI in Drug Development

    Clinical Research News | High-impact opportunities for leveraging AI across the pharmaceutical R&D cycle are too numerous to count but won’t “automagically” solve any of the longstanding problems in ushering molecules to market. AI requires human attention to match tools to tasks for ensuring the accuracy of model predictions, and the pitfalls are dangerously easy to miss, according to a Novo Nordisk presentation at this week’s Scope X conference in Boston.

    May 21, 2026

  • Bacteria: Unsung Players in the Tumor Microbiome

    Clinical Research News | How cancer patients will respond to treatment can be anticipated based on their genetics as well as the tumor microenvironment, although one relevant component is often all but dismissed: the tumor microbiota. This is despite an abundance of evidence that a cancer’s microbial community plays a major role not only in therapeutic effects but also in tumor development, progression, and metastasis formation.

    May 20, 2026

  • FDA Conversation on Selective Safety Data Collection

    Clinical Research News | Earlier this month, TransCelerate BioPharma released a summary report focused on selective safety data collection (SSDC) gathered during a joint tabletop exercise convened in late 2025 in collaboration with U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI).

    May 19, 2026

  • 23andMe: How Genetics Contribute to GLP-1 Drug Outcomes

    Clinical Research News | An engaged research cohort of over 11 million genotyped individuals has enabled 23andMe to produce a library of more than 300 peer-reviewed publications over the past 16 years. Following a 2025 bankruptcy filing, when it reemerged as a nonprofit medical research organization, the focus has settled on providing individuals with access to their genetic information, supporting genetics education, and studies that provide a deeper understanding of human genetics.

    May 13, 2026

  • AI Framework for Differentiating Neurodegenerative Diseases

    Clinical Research News | A team of computational scientists at Lund University (Sweden) have built a deep, joint-learning proteomics model for improving the diagnostic accuracy for a handful of dementia-related conditions which in primary care settings remains challenging due to a shortage of informative biomarkers. Predicting these different but correlated pathologies together with a single blood test would facilitate a differential diagnosis with speed and confidence.

    May 12, 2026

  • Strengthening Patient Recruitment Through Smarter Trial Design

    Clinical Research News | Patient recruitment remains one of the most persistent bottlenecks in clinical research. Issues such as increasing protocol complexity, competition for eligible participants, and growing expectations around diversity are placing ever-greater pressure on study timelines. However, recruitment challenges are often a symptom of earlier decisions; when protocol feasibility is misjudged, or patient realities are not fully considered, recruitment delays become inevitable.

    May 8, 2026

  • The Scope of Things: Bridging Health Equity in Clinical Research

    Clinical Research News | Among the shifting tides around DEI, people are finding creative ways to keep the momentum going for equitable clinical trials. Ramona Burress, co-founder of Onyx Health Collective, and Cassandra O’Neal, founder of Illuminated Arc Consulting, discuss a practical look at health equity in clinical trials in the latest episode of The Scope of Things.

    May 6, 2026

  • Much Progress Needed Planning Research to Consider Sex as a Biological Variable

    Clinical Research News | In 2016, the National Institutes of Health (NIH) introduced a policy requiring grantees to consider sex as a biological variable in their experimental design, analyses, and reporting. Now a team from Northwestern University has assessed progress, highlighting significant room for improvement.

    May 5, 2026

  • Follow the Money: AKT1-Selective Inhibitors, Vision Restoration Treatments, Neurology and Neuropsychiatric Treatments

    Clinical Research News | Terremoto Biosciences advances lead AKT1-selective inhibitor programs through phase 1 clinical development; Ray Therapeutics provides support of late-stage clinical development and commercial readiness for the company’s lead program in retinitis pigmentosa; Tortugas advances its two lead candidates; and more.

    Apr 30, 2026

  • FDA Piloting Real-Time Review of Clinical Trial Data From AstraZeneca, Amgen

    Clinical Research News | The U.S. Food & Drug Administration is piloting real-time review of data from AstraZeneca and Amgen clinical trials, both using Paradigm Health's Study Conduct platform, and has issued a call for feedback on how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials. FDA has already received and validated signals for AstraZeneca’s trial and expects this to be the first step in implementing real-time clinical trials (RTCT).

    Apr 29, 2026