• Fall News, Updates From Medable, Thermo Fisher, VA, Seqster, Medidata, More

    Clinical Research News | New products, collaborations and deployments from the past two months from Medable, Thermo Fisher, Seqster, Takeda, Medidata, Caris Life Sciences, Oracle, Lyft, Elsevier, and more.

    Nov 10, 2020

  • 1.7 Million New Yorkers Infected, ‘Long COVID’ Lung Damage, Myocarditis Not So Common: COVID-19 Updates

    Clinical Research News I Statin treatment may prevent deaths, COVID-19 worsens tinnitus, delirium early symptom in elderly, monoclonal antibody LY-CoV555 reduces hospitalization, phase 3 trial underway for REGN-COV2 antibody cocktail, remdesivir shows no mortality benefit, pandemic effects on childbirth, seven forms of disease identified, twenty percent experience GI symptoms, osteoporosis drugs may offer protection, and Europe linked to spread. Plus: Skin symptoms reveal ‘long haulers’, autoimmune antibody culprit for blood clots, smartphone app to reach at risk communities, increased discrimination against Asian Americans affecting their health, and smartwatch predicts COVID-19 infection.

    Nov 6, 2020

  • Five Reasons Remote Site Access Benefits Sponsors and CROs in Clinical Trials

    Clinical Research News | The current pandemic has necessitated a drastic shift for remote site access in clinical trials, leading to a flood of technology vendors in the market with solutions to assist sponsors and CROs. Vendors that provide Electronic Investigator Site File (eISF) and Remote Site Access technology solutions are experiencing a mass scramble of sponsors and CROs looking for solutions to support a pivot due to COVID—a pivot to remote processes that is here to stay far beyond the pandemic.

    Nov 4, 2020

  • Air Pollution Compounds SARS-CoV-2, Daily Aspirin Reduces Death Risk, NYC Cases Linked To Europe: COVID-19 Updates

    Clinical Research News I Acuity score predicts outcomes, elderly population at highest risk for COVID-19 death in care homes, Black Hispanics suffering worst outcomes, death rates drop by half in England, healthcare workers and their families account for a sixth of hospital admissions, and the pandemic will profoundly affect births and gender roles. Plus: Diabetic kidney disease cells resemble COVID-19 damaged kidneys, one third of patients given EEG have frontal lobe abnormalities, most people develop strong antibodies that last months, recovered individuals may be asymptomatic carriers, many COVID-19 patients have vitamin D deficiency, and vaccine tracker provides real-time updates.

    Oct 30, 2020

  • AiCure Announce Open Source Computer Vision Platform

    Clinical Research News Online | AiCure has announced OpenDBM, an open-source version of its computer vision and AI-powered digital biomarker platform. The platform's transparent framework will give the scientific community access to AiCure's digital biomarker algorithms.

    Oct 29, 2020

  • Streamlining Data Management In Clinical Trials With Artificial Intelligence And Machine Learning

    Clinical Research News | Quality, accurate, and comprehensive clinical trial data are essential for a successful clinical trial. Without this information, companies cannot ensure the safety and efficacy standards that will pass regulatory review.

    Oct 29, 2020

  • Follow the Money: Wearables for Clinical Research, Trials for Vaccine Patches

    Clinical Research News | Wearables for clinical research, clinical trials launch for a vaccine patch that doesn’t require refrigeration, exploring therapeutics for preterm birth, Sickle Cell Disease treatments, and more.

    Oct 28, 2020

  • Open Wearables Initiative Seeks Industry Data, Algorithms

    Clinical Research News | The Open Wearables Initiative (OWEAR) is evaluating a significant expansion of its vision and seeking industry input to build consensus.

    Oct 27, 2020

  • Why Diversity Matters: COVID-19 and the Search for a Vaccine

    Clinical Research News | As the pandemic continues, infecting over 30 million people and killing more than 1 million worldwide, emerging data suggest that COVID-19 is disproportionately impacting communities of color, and as scientists race ahead to develop a safe and effective vaccine, some experts have highlighted the need to address the lack of diversity in clinical trials considering the populations at greatest risk stand to benefit the most from this research.

    Oct 27, 2020

  • 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

  • Common Cold May Lessen Severity, ‘Brain Fog’ Really PTSD, Eyeglasses A Fourth Defense Mechanism: COVID-19 Updates

    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.

    Oct 9, 2020

  • Where Two Technologies Intersect Marks a Clinical Research Turning Point

    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.

    Oct 8, 2020

  • Next Step Forward: PRA Named CRO for Leukemia & Lymphoma Society Global Master Clinical Trial

    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.

    Oct 5, 2020

  • Short-Lived Antibodies, Troubling Trends, Vitamin D, Delirium: COVID-19 Updates

    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.

    Oct 2, 2020

  • ‘Hybrid’ Trials Will Be Post-Pandemic Norm

    Clinical Research News | For Medable, a leading advocate of decentralized clinical trials (DCTs), COVID-19 attracted surprising if welcome attention to the idea of making studies more patient-centric. The pandemic helped grow company revenues 400% in the first half of 2020 and, in the estimation of CEO and co-founder Dr. Michelle Longmire (a Stanford-trained physician), accelerated DCT adoption by five years.

    Sep 30, 2020