• 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

  • Feasibility: The Art of Being Less Wrong, Faster

    Clinical Research News | Clinical trial complexity is at an all-time high, with today’s clinical trials being more complex in their design and execution, whilst also demanding more sophisticated data management, regulatory navigation, and operational coordination than trials conducted a decade ago.

    Apr 11, 2025

  • Veradigm Powering Up Research with Real-World Cardiometabolic Datasets

    Clinical Research News | As a longtime electronic health record (EHR) supplier for ambulatory care providers, Veradigm (formerly Allscripts) finds itself at the “intersection of research and patient care” with the wherewithal to offer medical practitioners research opportunities and clinical trial sponsors real-world data and solutions to support their R&D ambitions.

    Apr 10, 2025

  • The Scope of Things: AI Translating Clinical Trial Results, Improving Study Access, Aspirin Preventing Cancer Spread, More

    Clinical Research News | This month’s episode of the Scope of Things covers the latest news on setting expectations for Phase II cancer trials, insights about dementia from the Nun Study, and more, brought to you by host Deborah Borfitz. Ravi Parikh, medical director of data and technology applications shared resource at Winship Cancer Institute of Emory University, joins in to discuss TrialTranslator.

    Apr 9, 2025

  • Simplicity and Standards are the Starting Points for Pragmatic Trials

    Clinical Research News | Pragmatic trials, by name, have been around for well over a decade now and, while well intentioned, they remain poorly understood and currently offer a limited value proposition to study sponsors and contract research organizations.

    Apr 3, 2025

  • Withings Moves Beyond BMI with New Body Composition Scale

    Clinical Research News | Body Mass Index (BMI) is a long-used method to measure body fat with the formula kg/m2 (or lbs/in2 x 703 for imperial measurements). While it is a noninvasive and inexpensive way to measure body fat, there are arguments that BMI is inaccurate because it does not include other factors such as fat distribution, muscle mass, and metabolic health.

    Apr 2, 2025

  • Challenges and Opportunities for Advancing Health Systems Across Africa: An Activist’s Perspective

    Clinical Research News | Marieme Ba, CEO of Pharmalys, discusses the underrepresentation of African countries in clinical research. Study protocols she worked on referenced continents, except Africa. Other African countries were occasionally included in clinical trials for infectious diseases, but for the most part, the continent was overlooked. This begs the question: why is Africa not represented?

    Mar 28, 2025

  • DiMe Launches Resources Suite, Pistoia Alliance Reducing Carbon Footprint, More

    Clinical Research News | Digital Health Measurement Collaborative Community by the Digital Medicine Society released a suite of resources designed to effectively demonstrate the value of using digital endpoints in clinical trials; The Pistoia Alliance launched the next phase of its project to measure and reduce the carbon footprint of clinical trials; and more.

    Mar 27, 2025

  • Follow the Money: Eikon Advances Multiple Programs, Multi-Payload Antibody-Drug Conjugate, More

    Clinical Research News | Eikon will advance its programs aimed to treat advanced melanoma, as well as breast, ovarian, prostate, pancreatic, and brain cancers; Callio launches with innovative multi-payload programs designed to maximize therapeutic benefit for cancer patients; and more.

    Mar 26, 2025

  • Flatiron Health Pioneers International Patient-Level Data Sharing for Oncology Research

    Clinical Research News | Flatiron Health is breaking new ground in oncology research by enabling patient-level real-world data (RWD) sharing across four countries—U.S., UK, Germany, and Japan. Despite initial skepticism, researchers are now eager to access these harmonized electronic health record (EHR) datasets in a secure, cloud-based environment.

    Mar 20, 2025

  • AI Platform Aims to Translate Trial Results at the Point of Care

    Clinical Research News | For medical oncologists, the clinical quandary in treating patients is whether a newly marketed agent or drug cocktail will work as well as it did for the average cancer patient in a landmark clinical trial.

    Mar 18, 2025

  • Navigating the Real-World: How to Better Utilize Real-World Evidence

    Clinical Research News | Interest in Real-World Evidence (RWE) studies continues to grow. Data from ClinicalTrials.gov shows the number of RWE studies registered has increased dramatically since 2005, particularly in the last seven years. But what is RWE, how is it used in clinical trials and how can we work with Real-World Data (RWD) to produce RWE?

    Mar 14, 2025

  • Jumo Health Broadening its Health Equity Approach

    Clinical Research News | Jumo Health launched a suite of services to drive health equity in clinical trials in 2023 via a collaboration with I Choose Life Foundation, a nonprofit dedicated to addressing health disparities in the African American community. It helped the company pilot its first community engagement event in the form of a workshop to train local business and faith leaders to serve as trusted messengers of information about clinical research and the point-of-care experience.

    Mar 12, 2025