• 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

  • There’s Got To Be A Better Way to Fight Cancer When Everything Else Is Falling Apart

    Clinical Research News | Since the United States’ first coronavirus case was confirmed in January 2020, COVID-19 has disrupted healthcare in myriad ways—and oncology clinical trials have not been spared. We can do better, and here’s how.

    Dec 15, 2020

  • Sore Eyes Significant Symptom, IgA Antibodies Dominate Early Response, Prophylactic Nasal Spray Development: COVID-19 Updates

    Clinical Research News I Dogs detect COVID-19 in sweat, safety evaluation of ventilator sharing, two-thirds lose sense of taste and smell, ethics of human challenge trials, Oxford COVID-19 vaccine trial results, blood vessel damage in children, diabetes and cancer patients at greater risk, transmission from mother to neonate rare, and effects of COVID-19 exposure on healthcare workers. Plus: New oral antiviral could block transmission, metformin may reduce death risk in women, and UC Davis joins Novavax for late-stage COVID-19 vaccine trial.

    Dec 11, 2020

  • Seattle Children’s Therapeutics Adopts New Mode Of Drug Development

    Clinical Research News | Several years ago, Seattle Children’s Research Institute realized it would need to “think and act” more like a biotech company to ramp up the development of medicines for pediatric use to treat cancer and other typically orphan-status diseases of childhood. Earlier this year, they launched Seattle Children's Therapeutics to do just that.

    Dec 10, 2020

  • AML Umbrella Trial Reveals Upside Of Brief Wait On Treatment

    Clinical Research News | Four years ago, most patients with acute myeloid leukemia (AML) over the age of 60 faced the double whammy of a five-year survival rate below 5% as well as no FDA-approved targeted therapy available for their particular disease subtype to improve treatment outcomes. The groundbreaking Beat AML umbrella study, sponsored by The Leukemia & Lymphoma Society's (LLS), has been testing a variety of treatment approaches that are providing glimmers of hope against the devastating disease.

    Dec 8, 2020

  • CPAP Treatment Saves Lives, Kidney Disease Strong Risk Factor, Ethics of Continued Vaccine Trials: COVID-19 Updates

    Clinical Research News I One-third of children are asymptomatic, lung tissue recovers well, adverse outcomes unlikely in COVID-19 positive pregnant women, Type O and Rh negative blood groups at lower risk, immune mechanism that triggers cytokine storm, direct oral anticoagulants show no protection, overdose-related cardiac arrest rates surge, trial underway for nasal spray prophylaxis, protective factors in children, and pregnant women suffer mental health effects. Plus: Wuhan lockdown proves effective, ongoing vaccine trials and advancements, and triple combination therapy trial underway.

    Dec 4, 2020

  • The Importance of Experience and Dedication to Study Feasibility

    Clinical Research News | In most industries, a feasibility study evaluates whether or not a proposed project is possible to undertake or capable of being completed within a given set of parameters. Feasibility in clinical research is not much different. However, we in the clinical research service sector tend to use the term feasibility to address two very different aspects of our service: developing the project strategy and selecting investigational sites.

    Dec 2, 2020

  • NIH Launches New HIV Clinical Trials Network

    Clinical Research News | The National Institute of Allergy and Infectious Diseases (NIAID) announced four NIH HIV clinical trials networks that will lead clinical research over the next seven years to accelerate progress against the HIV pandemic. The new, streamlined network structure is designed to reduce administrative and oversight costs, allowing more funds to be allocated to clinical trials to advance four key areas of research emphasis: HIV prevention; HIV vaccines; HIV/AIDS adult therapeutics; and HIV/AIDS maternal, adolescent and pediatric therapeutics.

    Nov 30, 2020

  • Genome Editing Trials Need New Approaches To Informed Consent

    Clinical Research News | New models of implementing informed consent will be needed for clinical trials where participants are weighing the benefits and risks of genome editing, most immediately individuals with sickle cell disease (SCD) for whom the technique is potentially curative. Lessons learned in this new area of research will be important for a growing number of disease conditions.

    Nov 29, 2020

  • Virtual Visits Keep Clinical Trials Moving Forward – Even During a Pandemic

    Clinical Research News | During the pandemic, some solutions are coming to the forefront to support and enable greater participant engagement. Virtual visits and remote patient monitoring (RPM) technology, which have seen increasing adoption by healthcare providers to help keep patients and staff safe and adherent during the pandemic, can also help keep clinical trials moving forward.

    Nov 23, 2020