• 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

  • Number Of ED Visits Decreases Amidst COVID-19 Pandemic, Other News

    Clinical Research News | Healthcare systems in five states have reported a decrease in the number of emergency department (ED) visits since April, while hospital admission rates have increased in the same timeframe. A recent study urges public health officials to emphasize the importance of visiting the ED during the COVID-19 pandemic. This, plus more, is included in this week’s announcements and updates from the clinical research industry.

    Aug 7, 2020

  • Follow the Money: Investments for Underserved Lung Cancer Communities

    Clinical Research News | Stand Up To Cancer gets a big pharma investment aimed at achieving health equity for underserved lung cancer patients, including Black people and people living in rural communities. And Sema4 gets $121M to build dynamic models of human health and define optimal, individualized health trajectories.

    Aug 5, 2020

  • Are Our COVID-19 Trials Useful, Ethical? Researcher Raise Red Flags

    Clinical Research News | Groups of researchers are raising red flags about the quality of COVID-19 clinical trials. A group from Stanford and Yale warned that studies may not be well designed to contribute meaningful clinical evidence. Another group from Johns Hopkins cautioned against overstepping ethical bounds in public health surveillance. Meanwhile, many new trials are launched. 

    Jul 31, 2020

  • John Snow Labs, LabCorp, FDA, And More: News From July 2020

    Clinical Research News | July was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from John Snow Labs, LabCorp, the FDA, and more.

    Jul 30, 2020

  • Pandemic Inspires Impactful Public-Private Partnerships

    Clinical Research News | If COVID-19 has an upside, it’s that the public health crisis has turned fierce competitors unto friendly collaborators and forged unlikely partnerships between groups who tackle problems from a different angle.

    Jul 28, 2020

  • How St. Jude Research Hospital’s New SVP of Clinical Trials Administration is Weathering the Pandemic

    Clinical Research News | While the short-term impacts of the COVID-19 pandemic have certainly slowed clinical research, St. Jude’s new Senior Vice President of Clinical Trials Administration keeps a long view, with some initial goals—including an expanded clinical infrastructure and informatics—becoming more important than ever.

    Jul 27, 2020