• 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

  • Discovery Life Sciences, Mindpeak Partnership, Streamlining Communications, Rare Disease Referrals

    Clinical Research News | Discovery Life Sciences and Mindpeak enter a partnership; Cenevo has launched the Labguru Customer Portal; myTomorrows and Rare Disease Research team up; and more.

    Apr 28, 2026

  • Lung Cancer Trial Trends Show Geographic Concentration

    Clinical Research News | In research presented this week at the American Association for Cancer Research (AACR) Annual Meeting, trends surfaced showing that between 2020 and 2024, the number of unique sites in the United States where phase I clinical trials for non-small cell lung cancer (NSCLC) were conducted decreased by 44% and became increasingly concentrated at the top 20 highest‑volume clinical trial sites largely located in major cities.

    Apr 23, 2026

  • Pistoia Alliance Furthers Research on Using Social Media Listening in Drug Discovery, Clinical Research

    Clinical Research News | In an expansion of its advocacy work into clinical fields, the Pistoia Alliance has launched new patient research to shape the ethical use of social media listening in drug development. The work is part of its ongoing Social Media Real-World Evidence (RWE) project.

    Apr 22, 2026

  • Veristat Discovers a Goldmine of Opportunities in China

    Clinical Research News | Following an eye-opening experience at China’s largest biotechnology and life sciences event, Veristat is positioning itself as a first mover in accommodating the regulatory needs of multiple Chinese companies eager to enter European and North American markets. The shift comes in response to government policy reforms over the past decade, with purpose-built R&D cities and science parks in more recent years acting as physical accelerators.

    Apr 16, 2026

  • 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