• 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

  • Black Women with Breast Cancer Now Lead Champions of Clinical Trials

    Clinical Research News | For Black women diagnosed with breast cancer, the grim reality is that they are 41% more likely to die of the disease than white women. African American women are disproportionately affected by triple negative breast cancer (TNBC), the most aggressive form of the disease, but that only partially explains the discrepancy in the mortality rate.

    Mar 11, 2025

  • The Scope of Things: Sharing Patient Insights, Absence of Pregnant Women in Clinical Trials, Boosting Cancer Vaccine Work, More

    Clinical Research News | In this month’s episode of the Scope of Things, host Deborah Borfitz delivers the news on how an AI-powered trial screening tool outperformed human research staff, a strategy report on boosting cancer vaccine work, the issue of continued absence of pregnant women in clinical trials, and more. Plus, Rare Patient Voice founder and president Wes Michael also joins in to talk about how his company is connecting people undertaking research studies with participants eager to share their insights.

    Mar 6, 2025

  • AstraZeneca Scaling Up Use of Generative AI to Help Reach 2030 Ambitions

    Clinical Research News | Generative artificial intelligence is being used by AstraZeneca to expedite its five-year ambitions to be an $80 billion company, deliver 20 new medicines, and be carbon negative. The initial value-driving activities include the creation of AI assistants to help with 3D location detection on CT scans and facilitate knowledge extraction for clinical documents as well as an intelligent protocol tool built in partnership with medical writers.

    Feb 4, 2025

  • Thermo Fisher Lupus Registry, Major Partnerships, Glaucoma Testing, More

    Clinical Research News | Thermo Fisher Scientific launched the CorEvitas Systemic Lupus Erythematosus (SLE) Registry; MedTech Innovator announced new industry partners; Seonix Bio announced the US launch of SightScore for primary open-angle glaucoma; and more.

    Feb 27, 2025

  • Follow the Money: Rare Muscle Disease Treatment, Huntington’s Disease Trial, More

    Clinical Research News | Abcuro is advancing to a Phase II/III trial to treat a rare, chronic inflammatory muscle disease called inclusion body myositis; Atalanta Therapeutics plans to start Phase I clinical trials of the company’s RNAi therapies for a genetic form of childhood epilepsy and for Huntington’s disease; and more.

    Feb 26, 2025

  • Regulators Support ‘Pragmatism’ in Clinical Trials

    Clinical Research News | A panel of experts from inside several major pharma companies discussed regulatory initiatives around pragmatic trials in depth at the recent Summit for Clinical Trial Ops Executives (SCOPE). Henry Wei, M.D., head of development innovation at Regeneron; Gracy Crane, international regulatory policy lead for real-world data at Roche Products Limited; Melodi J. McNeil, director of regulatory policy and intelligence at AbbVie; Stephanie Derbyshire, clinical operations portfolio leader at Roche; and Kevin Bugin, associate vice president of global regulatory policy and intelligence at Amgen were all part of the panel.

    Feb 25, 2025

  • Scope of Things: SCOPE 2025, Participant Engagement Award Winners, AI Helping With Clinical Trials, More

    Clinical Research News | In this month's episode of the Scope of Things, host Deborah Borfitz provides the latest on new criteria for defining and diagnosing obesity, the case for including pregnant women in vaccine trials, an inert gas being tested as an Alzheimer’s treatment, and more.

    Feb 21, 2025

  • USC to Use Generative AI to Make Cancer Clinical Trials More Efficient

    Clinical Research News | The Norris Comprehensive Cancer Center, owned and operated by the University of Southern California (USC) through its Keck School of Medicine, will serve as the initial testing ground for a platform powered by generative artificial intelligence (AI) that is designed to streamline clinical trial operations. This is the first U.S.-based academic site in the research network of California startup company Ryght.

    Feb 20, 2025