• FDA Says Real-World Evidence Could Generate Incorrect or Unreliable Conclusions

    RAPS |  Fifteen top FDA officials published an article in the New England Journal of Medicine this morning attempting to clarify a definition for real-world evidence (RWE), and flagging areas of promise and concern.

    Dec 8, 2016

  • ERT Acquires Exco InTouch

    Clinical Informatics News Brief | ERT announced this morning that it has acquired Exco InTouch. Financial terms of the transaction were not disclosed.

    Dec 8, 2016

  • 21st Century Cures Act Passes the Senate to Politician Applause

    Clinical Informatics News | The United States Senate just approved the 21st Century Cures Act in a 94-5 vote. The omnibus bill passed the House of Representatives last summer by a wide margin. The vote today also reflects bipartisan support. Passage of the Act “signals an encouraging moment for the nation that their government can make progress on behalf of the American people,” said the Bipartisan Policy Center

    Dec 7, 2016

  • With Nod To Biden Senate To Say Yes To Cures Spending Reform Bill

    Xconomy |  The U.S. Senate cleared the way for the 21st Century Cures Act, an omnibus healthcare spending and reform bill, by voting 85-13 to end debate.

    Dec 6, 2016

  • Rapid Lab Tests Can Help Reduce Antibiotic Resistance

    STAT |  Rapid-culture diagnostic techniques can help fight antibiotic-resistant bacteria and the long hospital stays that can accompany them.

    Nov 30, 2016

  • Takeda, CluePoints, Mayo Clinic, and More: News from November 2016

    Clinical Informatics News Briefs | News, products, and partnerships from around the clinical trial and healthcare community including news from Takeda, CluePoints, Mayo Clinic, and more.

    Nov 23, 2016

  • Building the Pool of Alzheimer’s Trial Volunteers

    Clinical Informatics News | An effort is underway to identify and collect healthy adults with various APOE gene statuses to potentially match them with available Alzheimer’s disease research studies. The GeneMatch program aims to create a pool of willing Alzheimer’s trial participants already characterized with APOE gene status.

    Nov 23, 2016

  • Everyone Wins: Portable Genomics Hopes To Benefit Patients In Data Acquisition

    Clinical Informatics News | Patrick Merel wants to change the conception of how data is acquired for medical research. This is why he has recently launched a mobile app through his company, Portable Genomics, that allows users to monitor their genetic data and control how it is distributed to corporations for research.

    Nov 23, 2016

  • Alzheimer’s Drug Fails in Late-Stage Trial Dashing Hopes

    STAT |  An investigational Alzheimer's treatment from Eli Lilly failed to slow the progression of the memory-destroying disease in a late-stage trial.

    Nov 23, 2016

  • Could Gamification Improve Clinical Trials?

    Applied Clinical Trials |  Gamification is the application of game design principles and techniques to non-game contexts intending to create value for players and stakeholders alike. If applied, this principle can potentially drive greater innovation and efficiencies in clinical research.

    Nov 22, 2016

  • As Trump Prepares For Office, Biden's "Moonshot" Hangs In The Balance

    STAT |  The fate of Biden's initiative against cancer now rests with a lame-duck Congress, which is considering legislation that would provide significant funding for the effort.

    Nov 22, 2016

  • Cancer Clinical Trials Often Exaggerate Real-World Benefits of Drugs

    STAT |  Cancer clinical trials often overstate the benefits of drugs when they're used in the real world, where patients tend to be older and sicker.

    Nov 21, 2016

  • Medidata Introduces eConnect Partner Program

    Clinical Informatics News Brief | Medidata today announced the launch of the Medidata eConnect Partner Program. The collaborative initiative will enable the integration of healthcare data with the Medidata Clinical Cloud, a platform powering clinical trials for nearly 800 life sciences organizations worldwide.

    Nov 18, 2016

  • PatientsLikeMe Shares Medication Reviews on Walgreens.com

    Clinical Informatics News Brief | PatientsLikeMe has expanded the scope of patient-generated information it offers through Walgreens.com to help more people better understand how certain prescription medications may affect them.

    Nov 17, 2016

  • FDA Regulator Defends Controversial Decision to OK Sarepta Drug

    BostonGlobe.com |  The nation's top drug reviewer Wednesday criticized Sarepta Therapeutics Inc.'s program to develop the first drug to treat Duchenne muscular dystrophy, saying the Cambridge biotech's clinical study involving a dozen patients -none of whom took a placebo for comparison purposes - "left so many questions."

    Nov 17, 2016

  • 23andMe President Andy Page Steps Down

    Business Insider |  Andy Page is stepping down as president at 23andme and will remain on the company's board, according to a letter sent to employees. The news comes only a few weeks after it was reported that the company won't be pursuing next-generation sequencing.

    Nov 17, 2016

  • DrugDev Acquires SecureConsent, Launches Patient Solutions Unit

    Clinical Informatics News | DrugDev announced today the formal acquisition of SecureConsent, an e-consent solution deployed on tablets and other mobile devices (including BYOD) to optimize site and patient convenience with which DrugDev has been working closely.

    Nov 16, 2016