• 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

  • Antidepressant Prevents Severe Disease, Measles Outbreak Unexpected Outcome, Cytokine Storm Unlikely: COVID-19 Updates

    Clinical Research News I Arthritis drug improves outcomes in elderly, why COVID-19 spares children, increased risk of tracheal complications, E-cigarette users show poor immune response, effects of in-utero exposure, significant rise in depression, UIC launches trials on blood clot prevention, cytokine storm unlikely, and MRS reveals white matter changes. Plus: XPRIZE announces Pandemic Response Challenge, combination therapy advances, and UT opens post-COVID-19 clinic.

    Nov 20, 2020

  • Is COVID-19 Fueling A Race To Decentralized Trials?

    Clinical Research News | A new survey shows that COVID-19 has slowed enrollment, driven changes to protocols, and even paused clinical research. As a result of these issues, many companies are rushing to adopt decentralized clinical trial methods.

    Nov 19, 2020

  • TriNetX Announces Real World Data Partnership, Applies Model to COVID-19

    Clinical Research News | Medidata, TriNetX, and Datavant announced a partnership to enable users of Medidata’s end-to-end clinical research platform to securely link their clinical data with patient consent to de-identified patient data without unblinding the study. The real-world data component from TriNetX’s global network of healthcare organizations, has recently been used to gather data on COVID-19 outcomes.

    Nov 18, 2020

  • How a Focused eSource Solution Shortens Timelines in CNS and Pain Clinical Trials

    Clinical Research News | In CNS studies, to overcome the pileup of complicated eligibility criteria, extensive data collection, relentless monitoring requirements, and hefty patient burden, sponsors, research sites, and patients need a first-rate technology solution. Standard electronic data capture (EDC) applications into which data, once collected, is transcribed for easy handling are inadequate; the transcription step risks error and necessitates time-consuming validation and edit checks.

    Nov 16, 2020