• Psychedelic Therapies Enter a Crucial Phase as Clinical Research Accelerates

    Clinical Research News | As psychedelic and dissociative-based medications pick up more interest, they may enter mainstream psychiatry in the coming years. Though ketamine and psilocybin are highlighted for their potential, their mechanisms—and side effects—still require further investigation.

    Dec 16, 2025

  • 2026 Participant Engagement Award Finalists Address Pediatric Patients; Lupus; Vaccine Trials; Recruitment Issues

    Clinical Research News | Finalists have been announced in the 10th annual Participant Engagement Awards. Four projects from Biogen, Proximity Health Solutions, and BlackDoctor.org; Empath Labs; PACT; and Science 37 and RxE2 will be presented during a live judging session at SCOPE in Orlando, Florida, Feb 2-5, 2026.

    Dec 11, 2025

  • The Scope of Things: Practical Regulations Strategies for Clinical Efficiency

    Clinical Research News | The FDA’s decades-old regulation 21 CFR Part 11—which establishes criteria for electronic records and signatures to be considered trustworthy and equivalent to paper records—is in dire need of an update. Doug Bain, founder and consulting partner of ClinFlo, has his own proposal on reformations to streamline clinical trials and improve experiences for patients, sites, and sponsors, which he discusses extensively in this month’s episode of the Scope of Things.

    Dec 9, 2025

  • Statistical Considerations in Decentralized Clinical Trials

    Clinical Research News | Decentralized clinical trials (DCTs) aim to harness the power of technology to lower the burden of clinical trial participation, increase engagement and improve outreach and diversity. However, for these benefits to be realized, we need to understand the specific challenges created by DCTs and how to mitigate them.

    Dec 5, 2025

  • Next-Generation Immunotherapy Nears the Clinic with Dual Cancer Trials

    Clinical Research News | Glycans are the complex sugar chains found at abnormally high levels on the surface of cancer cells—and one of the toughest challenges in cancer treatment. A research team from the UC Irvine School of Medicine developed glycan-dependent T cell recruiters (GlyTRs), which represent a first-of-its-kind approach that bypasses traditional antibody mechanisms to attack cancer’s sugar-coated armor.

    Dec 3, 2025

  • Space Health Research Could Rack Up Many Earthly Dividends

    Clinical Research News | When the first all-civilian spaceflight, Inspiration4, was launched by SpaceX in 2021, it set into orbit the idea of future space habitation. It also marked the start of a long-term mission to understand the impact of the journey on everyday people without extensive astronaut training.

    Dec 2, 2025

  • Follow the Money: Hypertrophic Cardiomyopathy Therapeutic Candidate, Underserved Bleeding Disorders, Rare Disease Trials

    Clinical Research News | Braveheart will advance their small molecule therapeutic candidate, BHB-1893, for hypertrophic cardiomyopathy; Hemab Therapeutics will keep developing sutacimig as the first-ever prophylactic treatment for Glanzmann thrombasthenia (GT); AAVantgarde will continue to work on their trials for treatments for Stargardt disease and Usher 1B; and more.

    Nov 25, 2025

  • Walgreens Launches New Patient Advisory Board, Advocate Health National Center for Clinical Trials Announced, P95, Julius Clinical Merge

    Clinical Research News | Walgreens launches the Walgreens Pharmacy Patient Advisory Board; Advocate Health announces Advocate Health National Center for Clinical Trials, the U.S.’s first, largest, and most inclusive clinical trial network; P95 and Julius Clinical have merged to form a global, full-service clinical research organization; and more.

    Nov 24, 2025

  • Checking the Boxes for Expanding Trial Start-ups to New Countries

    Clinical Research News | The patient-centered approach that has come into favor for planning and conducting clinical trials is, without question, improving care for trial participants. However, combined with other industry trends, including the proliferation of rare disease studies with much smaller patient pools, it is causing trial protocols to become more complex and is creating challenges in patient recruitment, which can lead to costly delays in a competitive and challenging macroeconomic environment.

    Nov 21, 2025

  • Early Rheumatoid Arthritis Studies Redefine Prevention and Clinical Research

    Clinical Research News | Rheumatoid arthritis has a reputation as a lifelong condition with no real cure and can only be managed after symptoms appear. However, researchers from the Allen Institute for Immunology, University of California, San Diego, and the University of Colorado Anschutz, have mapped out a way to detect dramatic immune system changes before the joints start swelling.

    Nov 19, 2025

  • Pioneering Platform for Collecting ‘Home-Reported Outcomes’

    Clinical Research News | As anyone contending with a complex chronic disease can likely attest, a lot has been “left on the table” when it comes to opportunities to achieve better health outcomes, lower costs, and greater personal satisfaction with their medical care. Tens of thousands of patients have voted for change by registering for the Folia Health app, which allows them to track their symptoms and share data about their own healthcare experiences with their care team or research studies.

    Nov 18, 2025

  • Making Sense of Sex in Clinical Trials

    Clinical Research News | Roughly two-thirds of pivotal clinical trials leading to a drug approval by the U.S. Food and Drug Administration (FDA) now include women at rates either at or above the disease burden on the female population. Yet progress on their inclusion has “plateaued” since the FDA began releasing its Drug Trials Snapshots in 2015 because of “fundamental issues in not considering female biology."

    Nov 12, 2025

  • Less Can Be More When It Comes to Collecting Data in Studies

    Clinical Research News | It is no secret that clinical trial protocols have grown increasingly complex, resulting in longer study durations, higher costs, and greater burden on patients and investigative sites. It has been a consistent, well-documented trend for more than two decades now.

    Nov 11, 2025

  • Next-Gen Weight-Loss Drug Moves Closer to Clinical Trials

    Clinical Research News | Developing a “super-tolerable” weight loss drug is one of the biggest challenges in obesity medicine today. Researchers recently reported the creation of a promising molecule, tridecaneuropeptide (TDN), which reduces food intake without triggering the awful side effects often associated with glucagon-like peptide-1 (GLP-1) drugs such as Ozempic and Zepbound.

    Nov 6, 2025

  • Site Payments: Transparency, Timeliness, and Trust

    Clinical Research News | For all the technological advances in clinical research, one issue remains stubbornly unresolved: timely, transparent payments to sites. At the latest SCOPE 365 ClinEco Connect, industry peers came together to examine why, after decades of discussion, site payment challenges persist, and what practical steps could finally close the gap.

    Nov 5, 2025

  • AI in Clinical Trials: Industry Leaders Discuss Implementation Challenges and Future Directions

    Clinical Research News | At SCOPE Europe, Allison Proffitt hosted a panel of pharmaceutical industry leaders to discuss the real-world implementation of artificial intelligence in clinical trials, moving beyond theoretical benefits to address practical challenges and measurable outcomes.

    Nov 4, 2025

  • Pangaea, Microsoft Collaboration, First-in-Class Monoclonal Antibody for Cancer, New LLM Tech

    Clinical Research News | Pangaea Data announces a collaboration with Microsoft; Ipsen acquires ImCheck Therapeutics; Flatiron Health released first-of-their-kind advances in LLM-extracted progression data and other uses; and more.

    Oct 29, 2025

  • Follow the Money: Best-in-Class Weight Loss Drug Trial, Novel eClinical Platform, Rheumatoid Arthritis, Other Diseases Treatments

    Clinical Research News | Kailera Therapeutics advances injectable dual GLP-1/GIP receptor agonist; Almac Group plans Almac Trial Coordinator, a first-in-class interoperable clinical trial technology platform; Elvara advances their upcoming phase 2 clinical trial of its lead candidate ELV001; and more.

    Oct 28, 2025

  • GenAI Agents and Regulatory Compliance: Streamlining Unstructured Data Extraction Gets a Lift from GenAI Agentic Frameworks

    Clinical Research News | Imagine that you’re a life sciences researcher tasked with answering a regulatory request that involves extracting meaningful data from over 200 clinical trial reports from various sources. You’re looking for patient demographics, study outcomes, adverse events, and dosage information. For decades, the industry has relied on manual effort, but GenAI agents enable far better unstructured data extraction.

    Oct 24, 2025

  • Europe's Clinical Trial Crisis: Industry Leaders Call for Urgent Action at SCOPE Europe

    Clinical Research News | European clinical research is at a critical crossroads, industry leaders warned last week at SCOPE Europe. Regulatory fragmentation, site readiness challenges, and prolonged approval timelines are driving sponsors to more competitive markets in Asia and the United States.

    Oct 22, 2025