Clinical Research News Online

Tocilizumab Lowers In-Hospitals Deaths, Vaccine Outlook Mixed, Plans To Launch Human Challenge Study: COVID-19 Updates
Oct 23 | 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. More
Next-Generation Pharmacovigilance With Natural Language Processing
Oct 22 | 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. More
COVID-19 Study-A-Thon Highlights Open Science Potential
Oct 20 | 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. More
Virus Susceptibility Age Independent, Low Risk for Newborns with COVID-19 Positive Mom, Immune Cell Activation Resembles Lupus Flare: COVID-19 Updates
Oct 16 | 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. More
EMD Serono Using Machine Learning To Optimize Enrollment
Oct 15 | 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. More
Takeda Case Studies On Wearables In Clinical Trials
Oct 14 | 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. More
Common Cold May Lessen Severity, ‘Brain Fog’ Really PTSD, Eyeglasses A Fourth Defense Mechanism: COVID-19 Updates
Oct 09 | Clinical Research News | Previous infection with a non-SARS-CoV-2 coronavirus may lessen severity COVID-19. Long term exposure to urban air pollution may have made COVID-19 more deadly for some. 86% of UK residents who tested positive this spring did not have the specific virus symptoms. And a new look at the interrelationship between COVID-19 and cancer. Plus, survey shows patients have concerns about their health and safety at in-office visits, TestBoston trial looks for previous infection, and Israel opens pediatric COVID-19 ward. More
Where Two Technologies Intersect Marks a Clinical Research Turning Point
Oct 08 | Clinical Research News | On a recent survey, nearly 80% of biopharma and device development execs said they plan to use, or are using, AI to improve R&D performance. At the same time, the COVID-19 pandemic has accelerated the industry’s adoption of Decentralized Clinical Trials (DCTs). As these two burgeoning technologies continue to mature, there is an opportunity for transformation in clinical research where AI and DCTs intersect. More
Next Step Forward: PRA Named CRO for Leukemia & Lymphoma Society Global Master Clinical Trial
Oct 05 | Clinical Research News | Last month, the Leukemia & Lymphoma Society (LLS) and PRA Health Sciences announced their partnership in LLS’s first-of-its-kind global master clinical trial to develop new treatments for children with relapsed acute leukemia. The LLS PedAL (Pediatric Acute Leukemia) master clinical trial will simultaneously test multiple targeted therapies for children who experience a relapse of their acute leukemia. Now PRA has signed on as the contract research organization for the trial. More
Short-Lived Antibodies, Troubling Trends, Vitamin D, Delirium: COVID-19 Updates
Oct 02 | Clinical Research News | Case fatality rates among minorities questioned, vitamin D matters, ECMO saving lives, concerning genetic mutations, rise in anti-Asian racism, older adults excluded from trials, treatment potential of diabetes drug, rise in alcohol consumption, risks to mental health and men’s testosterone level, scary changes in care-seeking behavior, antibodies not eternal, pre-existing immunity may be widespread, younger cohorts dying in India, mostly men calling the shots, and delirium a key symptom among the elderly. Plus, a wealth of industry news that includes trials targeting nursing homes, launch of an eight-state patient data registry and an app to quantify mask-wearing behavior. More

CATO SMS Unveils New Brand
Sep 17 | CATO SMS unveiled its new brand today, revealing an updated look and logo capturing the company’s powerful offering following the merger of CATO Research, LLC and Specialized Medical Services-oncology BV (SMS-oncology). More
Biofourmis Closes $100 Million Series C Funding Round Led by SoftBank Vision Fund 2 to Accelerate U.S. and Global Expansion
Sep 17 | Digital therapeutics leader Biofourmis closes $100 million Series C led by SoftBank. Funds will help accelerate virtual clinical trials business, among other initiatives. More
Patient Groups Issue Guidelines for Ensuring Access to Care and Treatment for Rare Disease Patients, Citing Critical Needs and Gaps Further Exposed and Stretched During COVID-19
Sep 17 | Global Genes and the Child Neurology Foundation, as part of the Rare Access to Critical Therapies (ACT) collaboration, announced today the joint release of a report highlighting and supporting guiding principles of rare disease care and access — which the groups assert are universally relevant to all patients with rare diseases. More
Litmus Health Achieves HIPAA Compliance and NIST Cybersecurity Framework Adherence for Real World Data Infrastructure
Sep 17 | Litmus Health, the research-ready infrastructure platform for real world data, that you might find interesting. As a bit of background, Litmus collects real world data from wearables and sensors, and analyzes these data for inclusion in clinical trials for their customers in pharma. This morning, the company announced that after a thorough third party security assessment, its infrastructure was determined to be secure and compliant when measured against federal security regulations. More
APIS Assay Technologies Ltd expands bioinformatics expertise with acquisition of Beogenomics
Sep 17 | Please see below for the latest news from APIS Assay Technologies Ltd announcing the acquisition of Beogenomics, a specialised software developer with major expertise in Bioinformatics and Artificial Intelligence (BIOX). Beogenomics develops both on-prem and secure cloud-based data analysis solutions — helping customers design, build and run custom tailored genomics & proteomics pipelines. The integration into Manchester-based APIS will support the launch of a new BIOX Service Line as part of the company’s ongoing Biomarker Research and Development activities. More

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