• 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

  • Measuring Deaths and Long-Term Effects, Questions About Russian Vaccine, Citizen Scientists Making Their Own: COVID-19 Updates

    Clinical Research News | COVID-19 will become seasonal (eventually), mental effects on children and pregnant women, gaps in vaccine interest, what’s behind disparities, a test to identify plasma donors, better way to measure deaths, thousands could have lasting nerve damage, what does and doesn’t put people at higher risk, reasons for rehospitalization, potential shortening of life expectancy, azithromycin okay by itself, and researchers question Russian vaccine while citizen scientists experiment with DIY ones. Plus, a backlog in oncology, AI put to work and seven digital health solutions get NIH funding.

    Sep 18, 2020

  • Pandemic’s Silver Lining: Lasting Research Innovation

    Clinical Research News | While non-COVID medical research, including clinical trials, has partially resumed after widespread suspensions, delays and slowdowns during the outbreak, subsequent waves of COVID-19 infections still threaten to re-occupy clinicians, researchers, and labs. Fortunately, adversity can trigger adaptation.

    Sep 16, 2020

  • Follow the Money: COVID Research, Decentralized Trials

    Clinical Research News | Big money to speed clinical trials for Freenome’s colorectal cancer blood test, both THREAD and Science37 get investments to advance decentralized research approaches for global clinical trials, and more.

    Sep 14, 2020

  • NSAIDS Are Safe, Near-Zero Hospital Transmission, Clinical Sites In Trouble: COVID-19 Updates

    Clinical Research News | NSAIDS are safe for COVID-19 patients, a CHOP study shows convalescent plasma appears safe and possibly effective for children, a Boston study shows very low rates of hospital transmission of COVID-19. Plus, NIH launches two Phase 3 trials for blood thinners, the International Vaccine Institute preps with Gates money, and Phesi warns that many clinical trial sites may not bounce back.

    Sep 11, 2020

  • 10 Buzzwords for Virtual Trials and Remote Monitoring You Should Know

    Clinical Research News | Standardized vocabulary in clinical research operations is essential. We conducted surveys and documented conversations with the research community while they work to shape an entirely new approach to clinical research operations.

    Sep 9, 2020

  • Telemedicine Allows ‘Unlimited Communication’ Crucial To Weight Loss Success

    Clinical Research News | Many chronic diseases—including high blood pressure, raised cholesterol, type 2 diabetes, lower back pain, and some cancers—are closely related to being overweight, and patients need ongoing, sometimes daily, guidance and interaction with their doctor for sustained weight loss. Telemedicine is an affordable way to do that and the results can be better than what can be accomplished with in-person visits.

    Sep 8, 2020

  • Steroids, Vaccine Distribution, Depression and Pregnancy Concerns: COVID-19 Updates

    Clinical Research News | A protease inhibitor used to cure a deadly coronavirus-causing disease in cats holds potential for testing in humans, a comparative look at current treatment approaches, proposed Fair Priority Model for vaccine distribution and needed reforms to the FDA’s Emergency Use Authorization process, concerning trends among pregnant women, rising rates of depression, promising news on steroids, and multiple trials on the launch pad—all among the explosion of COVID-19-related news over the past week.

    Sep 4, 2020

  • Clinical Trials For Companion Diagnostic Approval

    Bio-IT World | The regulatory framework around drug and diagnostic co-development, and how to overcome the inevitable hurdles, was the subject of multiple presentations at the 12th Annual Next Generation Dx Summit held virtually last week. Representatives from pharma and FDA weighed in on the clinical trials required to get companion diagnostics to market.

    Sep 2, 2020

  • Don’t Waste A Pandemic: Patient Advocates Call For Continuing Growth Toward Patient Centricity

    Clinical Research News | The COVID-19 pandemic has forced clinical trial sponsors and sites to think outside the box, offering innovative services to help patient recruitment, sample collection, and other phases of clinical research. There’s also another voice that needs to be considered: namely, that of the patient.

    Aug 31, 2020

  • Hydroxychloroquine, Remdesivir, Rehab: COVID-19 Updates

    Clinical Research News | Recommendations for COVID-19 rehabilitation, four months of data from Italy’s use of hydroxychloroquine, more data on which comorbidities are most dangerous, Remdesivir data, and more on imaging. Plus, research grants and a convalescent plasma architecture.

    Aug 28, 2020

  • Pack Health Deploying Digital Coaches For At-Home Disease Management

    Clinical Research News| The pandemic has deepened the disconnect with healthcare providers for patients with chronic conditions by reducing the frequency of in-person encounters while heightening patients’ anxiety about how to self-manage and access trusted health advice when they need it. Pack Health specializes in digital health coaching for just such scenarios.

    Aug 26, 2020

  • Caris, Thermo Fisher Scientific, And More: News From August 2020

    Clinical Research News | August was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Caris, Thermo Fisher Scientific, and more.

    Aug 24, 2020