• Revolutionizing Clinical Trials with Generative AI

    Jul 19 | Clinical Research News | The rapid advancements in artificial intelligence, particularly generative AI (GenAI), are enabling broader technology acceleration and driving a significant transformation in the healthcare industry. This democratization of AI capabilities opens the door to widespread innovation across clinical trials and drug development and represents a unique change in thinking compared to previous technological advancements. More
  • Children’s Hospital Colorado Launches Research Institute For Children’s Health

    Jul 17 | Clinical Research News | After more than 50 years of working together, Children’s Hospital Colorado has established a formal partnership with University of Colorado Anschutz Medical Campus to launch the Colorado Child Health Research Institute. The Institute aims to unite more than 500 physician-scientists, researchers, nurse-scientists, and other investigators and enable them to develop treatments that improve the lives and health of child patients. More
  • Digital Endpoints Gaining Ground in Industry-Sponsored Trials

    Jul 16 | Clinical Research News | A recent analysis of interventional clinical trials by the Tufts Center for the Study of Drug Development (CSDD) has found that use of digital endpoints has been growing rapidly since 2015 with drug developers now initiating an average of about 35 such studies each year. News of the uptick isn’t entirely surprising, given mounting evidence that the approach can improve operational performance and ease patient burdens in clinical trials and in clinical practice, while [potentially] yielding financial net benefits to developers. More
  • Fresh Take on How to Conduct Rare Disease Clinical Trials

    Jul 11 | Clinical Research News | A boutique clinical trial program launched less than two years ago to redirect the way clinical trials for rare diseases are conducted now knows it “vastly underestimated” demand. Uncommon Cures, a privately held U.S. company, already has eight signed contracts, is negotiating five more, and is actively talking with more than 50 clients about possible trials. More
  • Proscia, Nucleai Partner to Link Digital Pathology, AI-Predictive Biomarker Platforms

    Jul 09 | Clinical Research News | Proscia and Nucleai are partnering to integrate Nucleai’s predictive biomarker solutions into Proscia’s Concentriq software platform and make them available as part of Proscia’s AI-enabled pathology portfolio to better inform patient care. More
  • FDA Releases New Draft Guidance on Diversity Action Plans for Clinical Studies

    Jul 02 | Clinical Research News | Last week, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Comments on the draft guidance should be submitted by September 26, 2024. More
  • Follow the Money: Cholesterol-Lowering Monoclonal Antibody, Alzheimer’s Therapy, More

    Jun 27 | Clinical Research News | Marea Therapeutics progresses their MAR001 Phase 2 development plan and further advancement of additional pipeline programs; Alzheon plans to complete their pivotal Phase 3 program and prepare commercialization of their oral Alzheimer’s therapy with runway into 2026; more. More
  • New SAS Clinical Products, Payment Solution from IQVIA, Certara Platform Simplifies Medical Writing, More

    Jun 26 | Clinical Research News | SAS has expanded its portfolio to include SAS Clinical Acceleration Repository and SAS Data Maker for synthetic data; Seqster and Thread partner to accelerate access to real-world data for patients, researchers, and life science enterprises; Certara unveiled its next-generation CoAuthor regulatory writing software for medical writers; more. More
  • ClinEco Launches "Ask a ClinEco Luminary" Program for Expert Insights

    Jun 25 | Clinical Research News | ClinEco has launched the "Ask a ClinEco Luminary" program, offering its members direct access to leading experts in the clinical trials industry. The initiative aims to foster progressive dialogue and provide reliable expert advice to drive meaningful discourse within the ClinEco community. More
  • The Seemingly ‘Wicked Problems’ Keeping Pregnant and Lactating Women From Participating in Clinical Trials Might be Fixable

    Jun 20 | Clinical Research News | For anyone who has ever given birth, it will come as little surprise that few drugs have been approved for use during pregnancy and the breastfeeding period—even for something as basic as managing the symptoms of the cold or flu. The bigger shock may be that the absence of medicines extends to health conditions affecting pregnancy and birth such as postpartum hemorrhage and pre-eclampsia, two of the leading causes of maternal death. More
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SOT

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior writer Deborah Borfitz welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.