• Tocilizumab Lowers In-Hospitals Deaths, Vaccine Outlook Mixed, Plans To Launch Human Challenge Study: COVID-19 Updates

    Clinical Reserch News | Tocilizumab lowers in-hospital deaths, a global survey finds mixed responses to vaccine views and in the US they are driven partially by politics, and Monell Chemical Senses Center finds loss of smell more prevalent than we thought. Plus: the UK plans to develop a COVID-19 (SARS-CoV-2) human challenge study model, Texas launches a state-wide antibody study, and a call to action for the upcoming flu season.

    Oct 23, 2020

  • Next-Generation Pharmacovigilance With Natural Language Processing

    Clinical Research News | Surging use of telemedicine technology since the COVID-19 pandemic hit the U.S. earlier this year has resulted in a massive influx of unstructured patient data to sort through when searching for drug safety signals and compiling adverse event reports required by federal regulators. Natural language processing (NLP) thus has a potentially bigger role to play in automating the pharmacovigilance process, starting with interpreting data in free text fields and doing some of the cumbersome analytical work.

    Oct 22, 2020

  • COVID-19 Study-A-Thon Highlights Open Science Potential

    Clinical Research News | In March, a group of date-sharing researchers assembled to review more than 10,000 COVID-19 publications, draft nine protocols, release 13 study packages, and assemble a distributed data network with 37 partners signed on to execute studies.

    Oct 20, 2020

  • Virus Susceptibility Age Independent, Low Risk for Newborns with COVID-19 Positive Mom, Immune Cell Activation Resembles Lupus Flare: COVID-19 Updates

    Clinical Research News I Group of 80 researchers warns against herd immunity approach, UK case of sudden hearing loss linked to COVID-19, 1 in 7 experience neurological injuries, blood type O may have lowest risk, significant percentage of mothers report increased insomnia and anxiety, 20% of young patients hospitalized require intensive care, NIH launches SeroNet to increase antibody testing capacity, MMR vaccine may offer trained immunity, and international open-access database aims to reduce duplication of research. Plus, over 200 molecules identified that impact severity of virus, UC Davis Health testing REGN-COV2 antibody ‘cocktail’, increase in US death rate unexplained by COVID-19 related deaths and more.

    Oct 16, 2020

  • EMD Serono Using Machine Learning To Optimize Enrollment

    Clinical Research News | Merck’s Sylvia Marecki and Omesan Nair teamed up for a presentation on harnessing machine learning to identify causal drivers of enrollment success in clinical trials at the recent Bio-IT World Conference & Expo Virtual. The Operational Design Center (ODC) at EMD Serono, a Merck KGaA affiliate, uses analytics to address study-related business questions such as the anticipated duration of enrollment and how to speed up the process.

    Oct 15, 2020

  • Takeda Case Studies On Wearables In Clinical Trials

    Clinical Research News | Broader adoption of digital biomarkers in clinical trials is dependent on their regulatory approval, and data quality remains the big hurdle, according to Ariel Dowling, director of digital strategy at Takeda Pharmaceuticals, who led a workshop on wearables at the recent Bio-IT World Conference & Expo Virtual. She presented two specific use cases of digital biomarkers for clinical validation and as a primary endpoint for internal decision-making.

    Oct 14, 2020