• Cautious Optimism About FDA’s One Pivotal Trial Policy

    Clinical Research News | Earlier this year, the U.S. Food and Drug Administration (FDA) made a single pivotal clinical trial the default requirement for getting a medicine to market in lieu of the traditional two-trial mandate. It was a controversial move designed to reduce clinical development costs for drug sponsors, but it comes with the peril of potential project failure if study results aren’t rigorously defensible—or if companies fail to invest heavily in the quality of that single trial using readily accessible tools for data monitoring, artificial intelligence (AI), and biosimulation.

    Apr 14, 2026

  • AI in the Clinical Space: What 2030 Looks Like

    Clinical Research News | Clinical research is entering a phase where “using AI” is no longer the headline, and redesigning clinical operations becomes the real work. Mike Sullivan, head of IT globally for development operations at Bristol Myers Squibb, joins The Scope of Things to discuss a persistent industry problem: clinical insight latency, the long delay between data being generated at sites and meaningful decisions being made by sponsors.

    Apr 9, 2026

  • AI Tool Adding Speed and Diversity to Cleveland Clinic Trials

    Clinical Research News | At Cleveland Clinic, a “medically trained” AI system is patient-finding for clinical trials, eliminating the tedium of manual chart reviews for sponsors and investigators requesting digital assistance. Synapsis AI, a Dyania Health technology, was vetted for the job and initially deployed at Cleveland Clinic’s Taussig Cancer Center and its Heart, Vascular and Thoracic Institute.

    Apr 8, 2026

  • Managing Metastatic Cancer: A Matter of Degree

    Clinical Research News | Cancer recurrence is a significant health issue and a major concern for survivors but could potentially be transformed into a manageable chronic condition with the advent of a magnetic nanoparticle hyperthermia system developed by the Israeli startup New Phase and newly installed at the Mayo Clinic last December. The novel technology uses iron oxide-containing nanoparticles that amass in tumors, which are then heated by an electromagnetic field to destroy them.

    Apr 7, 2026

  • Continuous Clinical Trials: History, Hype, and How to Make Them Work

    Clinical Research News | Food and Drug Administration Commissioner Marty Makary has been signaling a potential change to how clinical trials are conducted. Since assuming the Commissioner role, he has championed "continuous trials"  to accelerate drug development, calling the current phased approach inefficient.

    Apr 3, 2026

  • piRNA Blood Test Opens New Pathways for Longevity

    Clinical Research News | A simple blood test built on a handful of small RNA molecules could reshape how researchers study aging and predict survival. Led by Virginia Byers Kraus, M.D. Ph.D., professor in the departments of medicine, pathology, and orthopedic surgery at Duke University School of Medicine, a team of researchers identified piwi-interacting RNAs (piRNAs) as powerful and potentially causal predictors of mortality in older adults.

    Mar 31, 2026

  • Blood Biomarker “Clock” Detects Alzheimer’s Symptoms

    Clinical Research News | Researchers from the Foundation for the National Institutes of Health, Washington University in St. Louis, the University of California San Francisco, the University of Wisconsin-Madison, and other collaborators found that a plasma biomarker—the ratio of phosphorylated to non-phosphorylated plasma tau at position 217, written %p-tau217—can be used to construct a “clock model” that can predict when Alzheimer’s disease symptoms appear.

    Mar 26, 2026

  • Follow the Money: Brain-Computer Retinal Implant Trial Results, Alzheimer’s Platform Development, More

    Clinical Research News | Science Corporation’s PRIMA trial results are featured in The New England Journal of Medicine and on the cover of Time; Cognito Therapeutics continues to clinically develop their Spectris platform; and more.

    Mar 25, 2026

  • Verily, Samsung Partnership, Scite MCP Improves AI Trustworthiness, Johnson & Johnson Receives FDA Approval

    Clinical Research News | Verily Life Sciences and Samsung Electronics America enter a collaboration; Research Solutions launches Scite MCP; Johnson & Johnson receives approval from FDA for TECVAYLI and DARZALEX FASPRO; and more.

    Mar 24, 2026

  • Is Agentic AI The ‘Next Leap Forward’ for Clinical Trial Data Management?

    Clinical Research News | In clinical trials, every second counts, both for patient outcomes and sponsor ROI. As data volumes grow and oversight expectations tighten under frameworks like ICH E6(R3), teams are being asked to do more, faster and with greater precision. It is no surprise then that agentic AI, which promises to deliver efficiencies far beyond previous models, is the current hot topic across the industry.

    Mar 20, 2026

  • The Brain’s Role in High Blood Pressure

    Clinical Research News | Hypertension, also known as high blood pressure, has long been thought of as primarily a disorder of the heart, kidneys, or blood vessels. A growing body of evidence suggests that, in a substantial proportion of patients, the condition originates in the brain.

    Mar 17, 2026

  • Clinical Operations in 2030: What Will It Look Like?

    Clinical Research News | Clinical Operations is entering a phase where the hype around artificial intelligence (AI) and digital transformation is giving way to something more meaningful. For the last decade, much of the industry’s effort has focused on layering new technologies onto existing processes. By 2030, that approach will no longer be enough.

    Mar 13, 2026

  • Smarter Study Designs to Improve Pediatric Rare Disease Trials

    Clinical Research News | Efforts to improve clinical trials for children with rare diseases must focus on ensuring flexibility while capturing the best data. Florence Mowlem, chief scientific officer at uMotif, joins the most recent episode of The Scope of Things to discuss how thoughtful study design—not just advanced technology—is essential for ensuring reliable data and strong patient participation.

    Mar 12, 2026

  • DECODE Initiative Seeks More Meaningful Endpoints for Obesity Drugs

    Clinical Research News | As the obesity drug market accelerates, clinical trial design is coming under renewed scrutiny, with growing pressure on sponsors to demonstrate benefits that extend beyond weight loss. The Digital Endpoint Collaboration for Outcomes Development (DECODE) Obesity initiative and cross-industry consortium, led by Ametris, is looking to validate new clinical outcome measures that capture how patients function and feel while on treatment.

    Mar 10, 2026

  • Rethinking Data Delivery in Clinical Research: Building Scalable, Secure, And Site-Centric Architectures

    Clinical Research News | In the era of decentralized trials and global research networks, the way we manage and deliver clinical data is undergoing a profound transformation. Historically, sponsors relied on manual processes and physical media—USB drives, CDs—to transfer essential trial data to investigator sites at study close-out.

    Mar 6, 2026

  • Medication Adherence Pill Could Solve Dire Healthcare Problem

    Clinical Research News | Medication nonadherence is a major, longstanding problem in healthcare, with the World Health Organization estimating 50% of patients with chronic diseases are not taking their drugs as prescribed. But MIT engineers are working to solve the problem with an ingestible and bioresorbable RFID-based sensor system, dubbed SAFARI, designed to safely and accurately monitor medication ingestion.

    Mar 3, 2026

  • New CEO of Sanofi, SEQSTER’s Harmonization Engine, Flatiron’s First Prostate Cancer Panoramic Datasets

    Clinical Research News | Sanofi appoints Belén Garijo as chief executive officer; SEQSTER launches 1-Click Data Refinery; Flatiron Health announces their first Panoramic datasets in the U.K. and Germany for patients with prostate cancer; and more.

    Feb 26, 2026

  • Follow the Money: Musculoskeletal Disease Trials, “Regulator-Ready Protocols” for Clinical Trials, More

    Clinical Research News | Angitia Biopharmaceuticals focuses on postmenopausal osteoporosis, osteogenesis imperfecta, and spinal fusion; Biorce’s clinical trial platform rolls out; and more.

    Feb 25, 2026

  • In an Ecosystem of Trust, Trial Enthusiasm can ‘Spread Like Wildfire’

    Clinical Research News | Ensuring that patients who participate in clinical trials are the ones who bear the burden of the disease is a major and well-recognized challenge due to barriers ranging from mistrust of research and science to lack of access to clinical trials and cultural and logistical barriers.

    Feb 19, 2026

  • Deloitte Survey Reveals Sharp US-International Split in Executive Sentiment as AI and R&D Productivity Take Center Stage

    Clinical Research News | Life sciences executives remain cautiously optimistic about 2026, but a striking geographic divide has emerged that reveals growing concerns about U.S. regulatory and pricing policies, according to Deloitte Consulting’s 2026 Life Sciences Executive Outlook. Andy Bolt, leader of the firm’s Life Sciences R&D Practice, presented the data earlier this month at the Clinical Trial Venture, Innovation, and Partnering event with SCOPE.

    Feb 24, 2026