• Evidentiary Equilibrium: Difficult To Attain But Not Impossible In Real-World Research

    Clinical Informatics News Contributed Commentary | Drug manufacturers plan Phase II-III research with utmost care, but all too often regard Real World Evidence (RWE) generation in Phase IV as a check-box activity. Not surprisingly, this approach is rarely successful.

    Apr 4, 2018

  • Platypus: Deep Data Dives For Clinical Data Reviewer

    Bio-IT World |  If you are creating a tool designed to give a sixth sense, of course you name it after a semiaquatic, egg-laying mammal endemic to eastern Australia. Not unlike the animal, Takeda's Platypus is made up of various parts, specifically designed to meet the medical reviewer's needs.

    Apr 3, 2018

  • The Government Wants To Free Health Data. Will That Unleash Innovation?

    STAT |  The Centers for Medicare and Medicaid Services wants to put patients in charge of their information - and it wants to do so explicitly to help app and device makers gain access to high-quality data.

    Mar 29, 2018

  • goBalto, Medial EarlySign, Veeva Systems, And More: News From March 2018

    Clinical Informatics News | March was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from goBalto, Medial EarlySign, Veeva Systems, and more.

    Mar 28, 2018

  • Sequencing Patients' Genomes Might Not Break The Health Care Bank

    STAT |  The first rigorous study of its kind finds that sequencing people's genomes might not lead to extensive and expensive follow-up care, researchers reported.

    Mar 22, 2018

  • SCOPE 2018: What Was Seen, What Was Heard

    Clinical Informatics News | Several weeks out from the event, we’ve provided a summary of the latest to come from the 2018 Summit for Clinical Ops Professionals.

    Mar 20, 2018

  • FDA Releases First Clinical Study Report For Approved Janssen Drug

    Clinical Informatics News  Today FDA posted the first Clinical Study Report (CSR) as part of its Clinical Data Summary Pilot, an effort to increase drug approval transparency announced by FDA Commissioner Scott Gottlieb in January. The first CSR comes from Janssen Biotech for the approval of Erleada (apalutamide), the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer, as well the first to use the clinical trial result, or endpoint, of metastasis-free survival.

    Mar 19, 2018

  • Survey Says: Patients Willing, Investigators Warning Of Mobile Trial Opportunities And Challenges

    Clinical Informatics News | The Clinical Trials Transformation Initiative (CTTI) conducted a survey of potential research participants as part of its Mobile Clinical Trials program. The results are in. Trial participants are enthusiastic about mobile trials, and challenges for sites and investigators are being better defined and addressed.

    Mar 15, 2018

  • It’s About Time To Start Looking At Study Subjects As Individuals

    Clinical Informatics News | Chris Beardmore, CEO & Co-founder of Anova Enterprises, argues that clinical trials need to change their traditional focus from observing large groups of largely undifferentiated patients to the individual patient as the unit of observation.

    Mar 13, 2018

  • Mayo Clinic Finds IBM Watson Increases Enrollment of Clinical Trials

    MobiHealthNews |  The Mayo Clinic has just released the results of a new study, which show an 80% increase in enrollment of clinical trials for breast cancer when using IBM's Watson for Clinical Trial matching system.  The Watson system uses artificial intelligence to analyze unstructured information and pull out insights from the data. 

    Mar 9, 2018