• 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

  • MSK Researchers Find Immunotherapy May Be A Good Option For BRCA2 Tumors

    Clinical Research News | Despite having similar levels of tumor mutational burden, cancers associated with BRCA1 and BRCA2 alterations respond quite differently to immunotherapy. Counterintuitively, the tumor type that typically harbors the fewer number of immune cells—BRCA2—appears to be more immunogenic and the reason may be that the mutation process generates foreign-looking peptides readily detected by the body’s DNA repair engine.

    Jan 6, 2021

  • Gamifying Eye Health, Heavy Investments, Acquisitions in Decentralized Trials, More

    Clinical Research News | Launch of the Decentralized Trials & Research Alliance, acquisitions focused on decentralized trials and remote administration, new wearables for remote monitoring, better training for nurses in clinical settings, and more.

    Jan 4, 2021

  • Top Stories of 2020: Real-World Data, Research Ethics, and Virtual Trials. And COVID-19

    Clinical Research News | This year clinicians everywhere have worked to understand COVID-19, but that wasn’t the only disease we were concerned about. Crucial research on cancer, rare diseases, and many other indications was put on hold while sponsors and CROs re-envisioned clinical trials virtually and worked to reassure participants that they were safe at sites.

    Dec 29, 2020

  • The Pandemic Has Proven a New Approach to Clinical Trials is Necessary

    Clinical Research News | The COVID-19 pandemic has accelerated the need for a new approach to how clinical trial teams work with patients. At the onslaught of the health crisis, restrictions, and heavy precautions on personal interactions brought clinical trials to a veritable standstill. This left the life sciences industry looking for alternative ways to maintain patient participation in clinical trials, primarily, as it relates to patient interaction and data collection.

    Dec 22, 2020

  • Follow the Money: Decentralized Trials, Stem Cell Research, Stroke Treatment

    Clinical Research News | Funding updates around the clinical research and clinical trials space including a Series C round to accelerate decentralized trials, a “digital health first” focused VC fund, more money for a healthcare ecosystem platform, an investment in prostate health at Mount Sinai, and an NIH grant for human placental stem cell research.

    Dec 21, 2020

  • Online Programs Piloted To Support ‘Long COVID’, Drive-Through and Live-In Trial Sites, AI Picks Drug Candidates: COVID-19 Updates

    Clinical Research News | COVID-19 deadlier than heart disease, cancer, and the flu, with in-hospital mortality rates 20.3% among inpatients. New data on baricitinib and remdesivir. Plus: NIH looks at SARS-CoV-2 infection in children, CDC uses Oracle’s EHR, Curebase launches drive-through clinical trial sites, and new vaccine trials launched.

    Dec 18, 2020