• Wholly Remote COVID-19 Drug Trial Gets High Marks On Operational Front

    Clinical Research News | A fully remote randomized clinical trial, born of necessity in the early days of the pandemic, provides evidence that the study model is viable even when testing drugs with potential heart rhythm effects. Whether the concept will be as well embraced post-pandemic remains anyone’s guess.

    Mar 9, 2022

  • Sponsors Validating Multiple Digital Endpoints For Clinical Trials

    Clinical Research News | The development and validation of novel digital endpoints in clinical trials was the subject of several case studies shared at the recent Summit for Clinical Ops Executives (SCOPE), including a pilot study of a speech-language assessment tool by Regeneron Pharmaceuticals and trials of at-home monitoring devices for gait speed and nocturnal scratching by Pfizer. Rapid adoption of wearables has provided opportunities to innovate and better understand patients and biomarkers of health abnormalities

    Mar 7, 2022

  • Fast Track Designation for Myeloid Checkpoint Inhibitor, Neuromodulation for Heart Failure, Digital Twins in Trials, More

    Clinical Research News | A first-in-class myeloid checkpoint inhibitor was granted fast track designation, clinical trial results are in for vagus nerve stimulation to treat heart failure, a clinical trial launches to assess glycosaminoglycan profiling as all-cancer detection method, and new agreements have been entered or extended to promote decentralized trials and the use of digital twins

    Mar 2, 2022

  • Rules And Roles Of Decentralized Clinical Trials Coming Into View

    Clinical Research News | The current regulatory landscape for decentralized clinical trials (DCTs), and a trio of use cases focused on medical devices and in vitro diagnostic (IVD) products, were among a bevy of presentations on the decentralized study model at the recent Summit for Clinical Research Ops Executives (SCOPE).

    Mar 1, 2022

  • Follow the Money: Immunological Therapeutics, Signal Regulatory Protein-Targeting Therapeutics, Regulatory Compliance Technology

    Clinical Research News | New pharma-focused venture cap fund, funding to drive trials for treating immunological and inflammatory diseases and shingles, and more.

    Feb 28, 2022

  • Takeda Test-Driving Clinical Trial Software Prior To Study Starts

    Clinical Research News | Takeda Pharmaceuticals is implementing a “digital visit testing site” for clinical trials, using internal volunteers to test-drive devices in a sandbox environment simulating real-world study conditions prior to their actual deployment. It’s an element of the company’s just-in-time software builds that kick off this month in “proactive preparation for the future.”

    Feb 25, 2022

  • Scoring System For Predicting ARDS Treatment Response In COVID Patients

    Clinical Research News | Researchers from Massachusetts General Hospital (MGH) and the University of Cyprus (Cyprus) have come up with a mathematical model that can predict treatment response for different subpopulations of patients with COVID-19 complicated by acute respiratory distress syndrome (ARDS) and determine biologic mechanisms of patient outcome.

    Feb 23, 2022

  • DE&I Initiatives May Need An Accessibility Component

    Clinical Research News | Ensuring the Black voice in clinical research was the focus of a panel discussion on diversity, equity, and inclusion (DE&I) at last week’s Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida. The conversation was led by two-time cancer survivor Kimberly Richardson, president of the Black Cancer Collaborative, who vividly recalls being scolded and silenced when she questioned why her slow-growing granulosa cell tumor needed to be aggressively treated with three-drug medicinal cocktail.

    Feb 21, 2022