• 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

  • Ethnic Disparities, Variations in Antibody Response, Transmission-Humidity Link: COVID-19 Updates

    Clinical Research News | More evidence for disparities in the prevalence of COVID-19 across racial/ethnic subgroups, different types of detectable antibody responses tell different stories, potential cause for the loss of smell, and a transmission-humidity link. Plus, vaccine trials in South Africa, and launch of phage-based vaccines.

    Aug 21, 2020

  • FDA Releases Civil Money Penalties Procedures For Not Posting Clinical Trials, Results

    Clinical Research News| The Food and Drug Administration released its nonbinding recommendations for civil money penalties relating to the data submitted to ClinicalTrials.gov earlier this week. They outlined how they plan to identify parties that have failed to submit required clinical trial registration or results information, what the investigation and notification process will be, and what civil money penalties may be assessed and when.

    Aug 19, 2020

  • New Study Highlights Women Underrepresented In Clinical Trials, Resulting In Side Effects

    Clinical Research News Brief | A new study from UC Berkeley and the University of Chicago suggests that women are more likely to suffer adverse side effects of medications than men, highlighting a disparity of representation in clinical trials.

    Aug 17, 2020

  • Racial Disparity in COVID-19 Trials, mAbs, Vaccine Updates

    Clinical Research News | Vaccine updates—both research and commercial, a new drug combo being tested for treatment, and a spotlight on the racial disparity in COVID-19 trials and impacts. Plus, mAbs on trial.

    Aug 14, 2020

  • Medidata Launches Centralized Monitoring Solution

    Clinical Research News | Medidata launched Medidata Detect today, a centralized statistical monitoring solution for clinical trials of new medicines, vaccines, and medical devices.

    Aug 13, 2020