• The FDA’s Playbook For Accelerating COVID-19 Vaccine Development

    Clinical Research News | At the recent COVID-19 and Cancer virtual meeting of the American Association for Cancer Research, the role of the U.S. Food and Drug Administration (FDA) in expediting the development and deployment of a vaccine was the topic of a keynote address by Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). His talk focused heavily on a pair of guidance documents issued by the agency last year, including one in October specific to requests for Emergency Use Authorization (EUA) for COVID-19 vaccines.

    Feb 16, 2021

  • Breastmilk Contains SARS-CoV-2 Antibodies, Lung Ultrasound Stratifies Patients, Updated Practice Points for Remdesivir: COVID-19 Updates

    Clinical Research News | Several promising COVID-19 treatments, majority of Los Angeles healthcare workers not confident about vaccine, patients with dementia at increased risk, pregnancy and vaccination, and AI model predicts risk of death. Plus: old drugs may be repurposed to treat COVID-19, NIH enrolling participants for Phase III clinical trial, New Yorkers more likely to take vaccine than before.

    Feb 12, 2021

  • A Deep Dive On mRNA Vaccines

    Clinical Research News | Messenger RNA (mRNA) vaccines were the focus of a symposium on COVID-19 vaccines held during last week’s COVID-19 and Cancer virtual meeting of the American Association for Cancer Research. To date, only two vaccines have received Emergency Use Authorization by the U.S. Food and Drug Administration and both are mRNA vaccines—one developed by Moderna and the other by Pfizer and BioNTech.

    Feb 11, 2021

  • How Renewed Focus On Customer Experience Can Change The Health Data Landscape In 2021

    Clinical Research News | In 2020, many companies started prioritizing UX for the first time. And the challenge they are facing includes how to stay agile and make continuous improvements within a remote workforce. This acutely applies to the fields of health data science and software development, where clarity, ease of use, and security are paramount. An improved digital experience informed by an agile approach is one such way that developers can create significant value and deliver on expectations in 2021.

    Feb 10, 2021

  • Inspire Plays Pivotal Role In Search For Super-Genes

    Clinical Research News | The pilot project of a new HealthJourney program being developed by healthcare social network Inspire is all-virtual recruitment for a clinical research study being conducted in partnership with Pfizer, the Manton Center for Orphan Disease Research at Boston Children’s Hospital (BCH), and Citizen Genetics. The study is endeavoring to identify people in families with a history of autoimmune disease who carry “super-genes,” variants that make them resilient to lung cancer progression

    Feb 9, 2021

  • COVID-19 And Cancer: An Unsettling Pairing

    Clinical Research News | The pandemic has had potentially far-reaching effects on the treatment of cancer patients and conduct of oncology clinical trials, according to panelists presenting at last week’s COVID-19 and Cancer virtual meeting of the American Association for Cancer Research. While the medical community seems to favor extending “interim” policies related to telehealth and study enrollment, it also worries about the unintended consequences of institutional safety precautions—notably, delays in patients getting needed care.

    Feb 8, 2021

  • Asymptomatic Infections Rising, Maternal Antibody Protection, Opaganib Shows Promising Results: COVID-19 Updates

    Clinical Research News I Social distancing benefits the individual and community, airborne transmission contributed significantly to cruise ship outbreak, viral load likely peaks at symptom onset, Plus: NIH funds study to identify risk factors for severe COVID-19 in children and BioNTech-Pfizer’s COVID-19 vaccine largely effective against B.1.1.7 variant.

    Feb 5, 2021

  • Trial Design For Medical Devices: Regulatory Challenges, Opportunities

    Clinical Research News | On behalf of Clinical Research News, Bridget Kotelly spoke with Teri Takle-Flach of Boston Scientific about the biggest challenges planning clinical studies today and the impact EU Medical Device Regulation.

    Feb 3, 2021

  • AI-Based Approach Crunches Real-World Data To Emulate Clinical Trials

    Clinical Research News | A computer scientist at The Ohio State University (OSU) recently demonstrated the potential of artificial intelligence to crunch real-world data and emulate randomized clinical trials, speeding the pace of drug repurposing.

    Feb 2, 2021

  • 23andMe Launches Severity Calculator, Middle-Aged Adults Also at Danger, High Omega-3 Index Reduces Mortality Risk: COVID-19 Updates

    Clinical Research News I Cluster randomized trials could help children return safely to schools, early anticoagulation therapy does not improve outcomes, recovered patients experience lasting effects. Plus: NIH launches database to track COVID-19 related neurological symptoms and 86% of doctors believe mental health, depression will be biggest non-COVID-19 public health issue.

    Jan 29, 2021

  • New DTRA Members, Veeva Now A Public Benefit Corporation, More

    Clinical Research News | Strategic collaborations to enable more diverse trial populations, advance combinatorial intravesical immunotherapy, and engage patients in a privacy-centric way. Plus: new partnership program for CROs and an Oracle integration for Cognizant’s Shared Investigator Platform.

    Jan 28, 2021

  • Risk Management During A Pandemic: How Pfizer’s Quality Management System Fared

    Clinical Research News | Nothing quite tests a risk-based management approach like a global pandemic that few predicted. And for Pfizer’s Melissa Suprin, the COVID-19 pandemic was the first big test of the quality management system.

    Jan 26, 2021

  • Five Variants of Disease, When Patient Stratification Scores Fail, Studies for Long COVID: COVID-19 Updates

    Clinical Research News| The UK’s patient stratification score doesn’t hold up to scrutiny, Fauci and others encourage doctors to equip themselves to argue for vaccines, NIH launches a study of “Long COVID”, and more. Plus: Siemens, with German funding, sets up more COVID-19 treatment facilities for South Africa.

    Jan 22, 2021

  • Drugs Targeting Cellular Aging May Prove Useful For Numerous Conditions

    Clinical Research News | Fundamental aging processes appear to be root-cause contributors to multiple conditions, ranging from heart attacks and cancer to neurodegenerative disorders like Alzheimer’s disease. Now a series of clinical trials will look at whether senolytics— drugs targeting cellular aging—could affect many or perhaps all other aging mechanisms because they are interlinked.

    Jan 21, 2021

  • How the Pharma Industry Can Solve Common Clinical Trial Bottlenecks

    Clinical Research News | The race to develop a COVID-19 vaccine has shone a light on the sometimes complex process of getting a drug to market like never before, providing an opportune time to examine several common bottlenecks associated with clinical trials and what the industry can do to alleviate them.

    Jan 18, 2021

  • Myocarditis Not Common Among Athletes, Pediatric Hospitalizations Rising, Gut Microbiome Influences Severity: COVID-19 Updates

    Clinical Research News I COVID-19 ICU patients experience higher rates of delirium and coma, ABM recommends women continue breastfeeding after vaccination, Wuhan study finds lingering symptoms in many, immunosuppressed patients show similar outcomes, and ICU nurses suffer toll on mental health. Plus: Princeton University spin-off launches AI COVID screening tool and poor mental health could impact vaccine effectiveness.

    Jan 15, 2021

  • Parexel Ejects Informatics Business, Calyx Launches

    Clinical Research News |Parexel today announced the completion of the separation of its Parexel Informatics and Medical Imaging business from the parent company. Parexel Informatics becomes Calyx, a provider of medical imaging, eClinical, and regulatory solutions and services to solve complex challenges in clinical research.

    Jan 11, 2021

  • Virtual Trials Should Not Mean Siteless Trials

    Clinical Research News | Growth in decentralized clinical trials and an increasingly impressive list of features and functionality associated with remote patient monitoring and engagement technologies are making the promises of so-called Virtual Clinical Trials closer to reality than ever. But should Virtual Trials mean siteless trials? Removing sites from the equation, on paper, seems like a win, leading to lower costs and more convenience. However, with patient compliance still posing a significant challenge for sponsors, removing the personal connection and accountability checks provided by site teams can place the entire study in jeopardy.

    Jan 11, 2021

  • Umbilical Stem Cells Promising Treatment, Long Term Impacts on Brain, Smart Vaccine Patch Under Development: COVID-19 Updates

    Clinical Research News I Pfizer funds long-term safety study on their COVID-19 vaccine, Phase 3 clinical trial results show Moderna’s vaccine is both effective and safe, Radx-rad program supports innovative approaches to gaps in testing and surveillance. Plus: Protective immunity could last several months, and more.

    Jan 8, 2021

  • Trendspotting: Decentralized Trials, AI, Real-World Data in 2021

    Clinical Research News | We gathered predictions from leaders in clinical research who are working hard to synthesize what 2020 brought us and apply learnings to 2021.

    Jan 7, 2021