• The Pistoia Alliance To Develop Toolkit To Support FAIR Implementation

    Clinical Research News Brief | The Pistoia Alliance recently announced the launch of its FAIR Implementation project. The first project milestone by the end of 2019 will be the release of a freely accessible toolkit to help companies implement the FAIR guiding principles for data management and stewardship.

    Jul 26, 2019

  • TransCelerate Points A New Way Forward For Clinical Trials

    Clinical Research News | The nonprofit collaborative TransCelerate BioPharma is making strides on multiple fronts to improve site-sponsor relationships and the clinical trial experience. It has even designed a Clinical Registry of the Future (RotF) in hopes of influencing change to government-sponsored registries that many have found confusing and unfriendly.

    Jul 24, 2019

  • What Does Risk Mean?

    Clinical Research News Contributed Commentary | Risk is ubiquitous in all areas of life and risk management is something that we all do, whether we are managing a clinical trial or simply crossing the road.

    Jul 22, 2019

  • Control Arm Supplementation: First Step Toward No-Placebo Trials

    Clinical Research News | Eliminating a study's control arm by substituting pre-existing real-world data (RWD) is an idea that has captured the imagination of industry sponsors looking to gain efficiencies and cost savings—and reduce participants' fears that they will be end up getting a placebo.

    Jul 16, 2019

  • The Human Microbiome Has Parallels With Forest Ecology

    Clinical Research News | The recently concluded Human Microbiome Project successfully captured host and microbial properties linked to disease in a trio of longitudinal studies. To microbiome researchers, comparing the human microbiome with forest ecology can be irresistible since it's a lot easier to see a tree than a bacterium.

    Jul 12, 2019

  • Speeding Drug Development For Kids With Cancer

    Clinical Research News | The current lag time between first-in-human and first-in-child clinical trials for kids with cancer is concerning to the early phase clinical trials program at the Dana-Farber/Boston Children's Cancer and Blood Disorders Center.

    Jul 11, 2019

  • Taking The Guesswork Out Of Trial Planning

    Clinical Research News | Companies like Oracle and Cytel are taking unique approaches to study start-up, hoping cross-vendor integration and workflow automation can simplify the global, complex clinical trial process.

    Jul 10, 2019

  • UnitedHealth Group Acquires PatientsLikeMe

    Clinical Research News Brief | UnitedHealth Group has acquired online patient community portal PatientsLikeMe as of June 19. As part of the acquisition, the startup will now become part of UnitedHealth Group’s research arm that focuses on healthcare improvements and innovation.

    Jul 8, 2019

  • Common Protocol Template Gaining Traction

    Clinical Research News | Growing numbers of study sponsors have been adopting the Common Protocol Template (CPT)—or at least its basic structure—since TransCelerate BioPharma released the first version in 2015.

    Jul 8, 2019