• 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

  • The Ongoing Impact of COVID-19 on Clinical Research

    Clinical Research News | In assessing the impact of COVID-19 on clinical research and development, companies are considering a range of factors including the ability of patients to access medicines and travel to trial sites, whether patients might decline to participate in clinical research, potential changes in regulatory guidance, and resource allocation at trial sites.

    Sep 28, 2020

  • New Patient Prediction Models From Hopkins, Mount Sinai, Two VA Studies, New Vax Trials: COVID-19 Updates

    Clinical Research News | Both Johns Hopkins and Mount Sinai release patient prediction models, Mass General publishes new blood test for patient stratification, two VA studies look at COVID-19 in vet populations, study shows widespread kidney damage with 30% of patients needing dialysis, and FDA issues a guidance for assessing COVID-19 symptoms in clinical trials. Plus, NIAID launches fourth clinical trial for a SARS-CoV-2 vaccine, NIH expands trials of convalescent plasma, and screening program launches for sub-Saharan Africa.

    Sep 25, 2020

  • Elsevier Launches SMART on FHIR Tool To Better Educate Patients

    Clinical Research News | Elsevier has launched PatientPass, a cloud-based patient engagement platform integrated with the Epic Electronic Health Record (EHR) system using SMART on FHIR. The new platform will let clinicians choose and deliver highly personalized, actionable content to patients in several formats, including on their mobile phones and via SMS alerts.

    Sep 22, 2020