• The Scope of Things: Tackling Misinformation, Updated Guidelines to Clinical Trial Reports, More

    Clinical Research News | This month at the Scope of Things, host Deborah Borfitz gives you the latest news on a precision medicine initiative in Sweden integrating research with healthcare, guideline updates on the reporting of clinical trials, and more. Briony Swire-Thompson, director of the Psychology of Misinformation Lab at Northeastern University Network Science Institute, also joins in to discuss the current misinformation epidemic and how clinical trials and sites can best deal with it.

    May 20, 2025

  • Solving Patient Recruitment: Privacy Protection, Data Standardization, More

    Clinical Research News | Patient recruitment remains a “never-ending challenge." Despite efforts to leverage real-world data to alleviate the difficulties, there has not been a surefire solution. During April’s Bio-IT World Conference & Expo, panelists gathered to discuss the roots of the problem and share ideas that could potentially solve this issue.

    May 15, 2025

  • AI Platform Could Aid Precision Dosing for Multiple Conditions

    Clinical Research News | Given information on two blood biomarkers, together with drug type and dose, artificial intelligence (AI) was used to create personalized “digital twins” of cancer patients in an interventional clinical trial at a pair of Singapore hospitals. The goal was to “optimize only their own doses, dynamically."

    May 13, 2025

  • The Path To TMF Inspection-Readiness

    Clinical Research News | Regulators are tightening their scrutiny of the trial master file (TMF), placing the onus on companies to be ready for evaluation. Inspection-readiness should be embedded from the beginning, rather than a reaction to a notice of an inspection.

    May 9, 2025

  • ALS Research Getting a Big Boost from Open Science Initiative

    Clinical Research News | A diagnosis of amyotrophic lateral sclerosis (ALS) is devastating news given to about 5,000 people in the U.S. each year. It is a rare central nervous system disease without a cure that relentlessly progresses, although death variably occurs anywhere from a few months to many years after symptoms first become noticeable.

    May 8, 2025

  • 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