• 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 Draft guidance expected to be issued by the end of 2021 should shed light on the three key issues outlined in the agency’s Framework for FDA’s Real-World Evidence Program.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