• Phage Therapy Comes Of Age

    Clinical Research News | Five years ago, phage therapy was a largely unknown approach to treating recalcitrant bacterial infections outside of Eastern Europe. But headline-grabbing stories of bacteriophages bringing people back from the brink of death has catalyzed interest in the century-old practice of using viruses to infect and kill disease-causing bacteria—especially now antimicrobial resistance has limited the usefulness of many antibiotics.

    Feb 17, 2020

  • Phages Provide Safety Net In Post-Antibiotic Era

    Clinical Research News | To fully appreciate the potential of Adaptive Phage Therapeutics (APT), it’s helpful to review history through the lens of company co-founder and Chief Scientific Officer Carl Merril. For nearly five decades, Carl has been championing the idea of using bacteriophages to treat infectious diseases—an idea for which he has been variably applauded, questioned, ignored, scolded, and, ultimately, vindicated.

    Feb 13, 2020

  • Undoing Antibiotic Resistance With Phage Therapy

    Clinical Research News | Perhaps no academic institution has worked longer on the clinical application of phages than Yale University where research efforts are focused on using the pathogen-fighting viruses to re-sensitize bacteria to the antibiotics they’ve grown resistant to. “We’re hoping to drive evolution in the other direction to preserve our antibiotic arsenal for longer,” says Benjamin Chan, Ph.D., associate research scientist in the department of ecology and evolutionary biology, who maintains a large natural-phage library.

    Feb 12, 2020

  • Phage Therapy: From Compassionate Use To Clinical Trials

    Clinical Research News | At least three different types of phage products currently exist, and all of them are being explored as potential therapeutic remedies for people with drug-resistant bacterial infections. These include natural phages that have not been modified at all, as well as genetically engineered phages where one or more of their genes get modified to optimize their killing potential against a pathogen.

    Feb 11, 2020

  • Phage Therapy Making A Big Comeback

    Clinical Research News | A resurgence of interest in phages over the past few years—in basic and translational research, as well as animal agriculture and aquaculture—is closely tied to the global rise in antimicrobial resistance, rendering once-standard treatments ineffective. In the newly declared “post-antibiotic era,” more than 35,000 people in the U.S. are dying each year from a drug-resistant superbug.

    Feb 10, 2020

  • Population-Based Simulator Analyzes Drug-Drug Interactions In Silico

    Clinical Research News | A newly FDA approved acne treatment was developed and supported by Simcyp, a division of Certara that used their Simcyp Population-based Simulator to expedite and inform drug development, while also providing safety label claim and pediatric dosing information without the need for testing in clinical patients.

    Feb 5, 2020

  • How Real-World Datasets Stack Up to Randomized Controlled Trials: Two Pilots Could Help Inform Regulatory Guidance

    Clinical Research News |Researchers at Brigham & Women’s Hospital (BWH), in partnership with data analytics company Aetion, have been working on a real-world data (RWD) pilot project under the umbrella of RCT DUPLICATE since May 2018 with the financial and leadership support of the U.S. Food and Drug Administration (FDA). The project’s initial goal expanded last April from replicating to predicting results of randomized controlled trials (RCTs) using health insurance claims data.

    Feb 4, 2020

  • Using Real-World Evidence To Gauge Drug Effectiveness

    Clinical Research News | Clinical trial stakeholders, most notably the U.S. Food and Drug Administration (FDA), continue to grapple with how to harness the value of real-world data (RWD) and real-world evidence (RWE) for demonstrating product effectiveness. Draft guidance expected to be issued by the end of 2021 should shed light on the three key issues outlined in the agency’s Framework for FDA’s Real-World Evidence Program.

    Feb 4, 2020

  • What Clinical Research Could Look Like With Patient-Centric Trials

    Clinical Research News | Cereval’s Head of Clinical Operations discusses ways to improve the way clinical trials are run, potential barriers to running patient-centric trials, and more.

    Jan 31, 2020

  • LabCorp, Medial EarlySign, Color, And More: News From January 2020

    Clinical Research News | January was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from LabCorp, Medial EarlySign, Color, and more.

    Jan 30, 2020

  • EHR Vendor To Pay $145 Million To Resolve Criminal, Civil Investigations

    Clinical Research News Brief | The Department of Justice announced this week that Practice Fusion will pay $145 million to resolve criminal and civil investigations relating to its electronic health records software.

    Jan 29, 2020

  • Janssen, Apple Launch Virtual Randomized Heart Trial

    Clinical Research News | A virtual randomized trial launching this month will investigate whether a collaboration between a new heart health app, a medication adherence program, and an Apple Watch can accelerate the diagnosis of cardiovascular events, increase healthful lifestyles, and decrease strokes and death rates, all at one percent the cost of traditional clinical trials.

    Jan 28, 2020

  • New Clinical Trial Models Make Studies An Option For More People

    Clinical Research News | The advent of precision medicine, marked by the need to recruit relatively rare cohorts of patients into studies, has ignited interest in new, more efficient models of clinical development ranging from “just-in-time” rapid enrollment to trials requiring no sites at all, according to Gaurav Singal, chief data officer at molecular insights company Foundation Medicine.

    Jan 22, 2020

  • Waving A Magic Wand To Fix Clinical Trial Challenges

    Clinical Research News | Jane Myles discusses the challenges in clinical trials today, and how things might change over time.

    Jan 21, 2020

  • Promising Developments in the War Against TB

    Clinical Research News | The latest Global Tuberculosis Report, released by the WHO in October 2019, contains both good and bad news. On the bright side, thanks largely to improved detection and diagnosis, more people than ever before received life-saving treatment for TB and there were fewer deaths. The number of new cases has also been on a steady decline.

    Jan 20, 2020

  • Improving Care with Lessons from Search Engine Technology

    Clinical Research News Contributed Commentary | Type “Fast Food” into Google, and without scrolling you’ll likely find the answers to any fast food-related question you could possibly want to know. Considering the billions of search results that could appear, how does Google know to show you exactly what you’re looking for?

    Jan 16, 2020

  • Missing Data On ClinicalTrials.gov Shows Failure Of Research Culture

    Clinical Research News Brief| Science Magazine breaks down which institutions are putting data into ClinicalTrials.gov, which aren't, and what this means for clinical research.

    Jan 13, 2020

  • Transformational Change To The Supply Chain

    Clinical Research News | When it comes to improving supply chain, thinking big is the only way to enable transformational change.

    Jan 10, 2020

  • Top 10 Stories Of 2019: Right-Sizing Site Selection, CRF Bracket Relaunch, And More

    Clinical Research News | As we head into 2020, we at Clinical Research News would like to take a moment and reflect on the achievements from this past year. In that spirit, here are the top 10 stories of 2019, ranked in order of popularity.

    Jan 9, 2020

  • Follow the Money: New Life Sciences Investment Firm, Funding for Deep Genomics, Verantos, ArcherDX, ChromaCode, And More

    Clinical Research News | Bridge Connector tackles health IT interoperability challenges. Verantos gets another grant to study real world evidence. Perceptive Advisors launches a new venture capital fund for early-stage life sciences companies, and more.

    Jan 7, 2020