• When Placebo Response Isn't Placebo Response: The Perils of Human Raters

    Clinical Informatics News | Contributed Commentary | Clinical trials of medicines for major psychiatric disorders often show startlingly high placebo rates — yet clinical psychiatrists know not to expect significant improvements from care and support alone. Trials must be designed with an awareness of factors that can create false placebo effects.

    Dec 5, 2014

  • Thomson Reuters, Linguamatics Launch Collaborative NLP Tool

    Clinical Informatics News Product Brief | Thomson Reuters and Linguamatics today announced a collaboration combining Thomson Reuters’ Cortellis with Linguamatics I2E text analytics platform. The tool—Cortellis Informatics Clinical Text Analytics for I2E—uses a single user interface to apply Linguamatics’ I2E text mining platform to Cortellis content including clinical trial information, epidemiology data, literature, press releases and conference proceedings.

    Dec 4, 2014

  • Congress Should fix the Priority Review Voucher Program

    WSJ | To spur further development of neglected tropical diseases, Doctors Without Borders believes Congress should fix the priority review voucher program. Judit Rius, U.S. manager and legal policy adviser, explains the proposals to Pharmalot.

    Dec 3, 2014

  • CRAs as Site Recruitment Managers: Pros and Cons

    Clinical Informatics News | Clinical research associates (CRAs) serve as the primary contact point between sites and sponsors, but should this access and position also lead them to be site recruitment managers?

    Dec 2, 2014

  • Will Americans Share Data with Researchers

    MobiHealthNews | About 68% of Americans are willing to share health care data with researchers, but that group tends to be wealthy, well-educated, and young. However, this group is also most concerned about data privacy.

    Dec 1, 2014

  • How to navigate big data in healthcare

    Computerworld | Kaiser Permanente CMIO John Mattison cautions healthcare organizations to take a hard look at the way they approach data to ensure that health information is an asset, not a liability. He also cites the need for a new role: a health data concierge.

    Dec 1, 2014

  • Holiday Reading – The FDA’s Busy Year

    Clinical Informatics News | The “drug” half of the Food and Drug Administration has been reexamining its role in a changing industry this year, reevaluating both how it reviews new kinds of biotech diagnostics, and where it fits in a healthcare system that has increasingly probed the limits of FDA oversight. Here are some of the big stories to come out of the FDA this year.

    Nov 26, 2014

  • Connecting Fitness Data to Health

    Forbes | Are consumers really taking their fitness device data to their doctors? Survey says No.

    Nov 26, 2014

  • CROs mostly positive on rule to make clinical trials transparent

    Outsourcing-Pharma.com | Last week, the NIH and FDA proposed measures that would require the release of summary results of clinical trials for products that are unapproved or unlicensed. CROs have expressed some concern about the transparency initiatives, but were mostly positive.

    Nov 24, 2014

  • Apotex Sues Health Canada Over an ‘Unlawful’ Ban on its Drugs

    WSJ | Apotex, which is one of the larger generic drug makers in Canada, is lashing out at regulators, alleging in a lawsuit that a recent ban on drugs from its Indian plants was illegal and politically motivated.

    Nov 21, 2014

  • New Rules for Clinical Trial Results Disclosure

    Nature News | Regulations proposed yesterday would increase clinical trial transparency.

    Nov 20, 2014

  • PHT Releases Electronic Neuropsychiatric Interview, Rater Training

    Clinical Informatics News | PHT has released an electronic version of the Mini International Neuropsychiatric Interview (M.I.N.I.) for electronic data capture, and has developed training for the tool that will improve data quality and optimize the uniformity of clinician-reported data capture across clinical studies.

    Nov 19, 2014

  • $2.6 Billion Drugs, Or Not

    Clinical Informatics News | The Tufts Center for the Study of Drug Development released new estimates today of how much it costs to develop and win marketing approval for a drug. The total? $2.6 billion.

    Nov 18, 2014

  • Regeneron Drug Lowers LDL for Patients Who Cant Take Statins

    Reuters | Just a day after Merck reported strong results from its IMPROVE-IT Vytorin trial, Regeneron presented its own clinical trial saying its drug helped 10 times as many patients lower their LDL.

    Nov 18, 2014