• FDA Launches Oncology Center For Excellence

    Clinical Informatics News Briefs | Even as rumors and speculation swirl around the new head of FDA under President Trump, the U.S. Food and Drug Administration announced today that it is establishing the Oncology Center of Excellence and appointing Dr. Richard Pazdur as its director.

    Jan 19, 2017

  • New FDA Chief Should Have Medical Experience Drugmakers Say

    Bloomberg.com |  President-elect Donald Trump's pick to lead the U.S. Food and Drug Administration should have a medical background, and the agency should continue evaluating new medications' effectiveness, drugmaker executives said in comments indicating opposition to two candidates for the regulator's top post.

    Jan 18, 2017

  • New Rule On Clinical Trial Reporting Doesn't Go Far Enough

    STAT |  A new rule requiring that all NIH-sponsored clinical trials be reported on ClinicalTrials.gov doesn't go far enough to improve sharing trial information.

    Jan 17, 2017

  • Site-Less Clinical Trial Depends On Pharmacists' Relationships With Patients

    Clinical Informatics News | Center Point Clinical Services, a contract research organization, launched what it calls “the world's first site-less, technology CRO,” designed to increase patient recruitment, engagement, and successful trial completions at lower cost.

    Jan 17, 2017

  • Using Real World Data to Enhance Clinical Trials

    Clinical Informatics News Contributed Commentary | Randomized clinical trials remain the trusted standard for assessing pharmaceutical drug and medical device safety and efficacy. Real world data can provide important health information about patients in the social context of their day-to-day lives.

    Jan 12, 2017

  • Sarah Cannon And Genospace Announce Merger To Enhance Cancer Care

    Clinical Informatics News Brief | Sarah Cannon today announced that Genospace will merge with its organization and become a wholly-owned subsidiary. Sarah Cannon and Genospace will harness and use molecular profiling data to more effectively match cancer patients to therapies in clinical trials.

    Jan 12, 2017

  • 2017 Best Practices Finalists Announced

    Clinical Informatics News Brief | Clinical Informatics News today announced nine finalists in its 2017 Best Practices Awards. Three of the finalists will be named winners at SCOPE, the Summit for Clinical Ops Executives in Miami, Florida, on January 25.

    Jan 11, 2017

  • Diversity In Clinical Trials: An Issue That We Can No Longer Ignore

    MedCity News |   Minorities-along with the elderly and women-have historically been underrepresented in clinical trials. FDA Commissioner Robert Califf called 2016 "The Year of Diversity in Clinical Trials." So how have we done?

    Jan 6, 2017

  • Biden To Tackle Broad Range of Cancer Issues Including Drug Prices After Leaving White House

    The Washington Post |  In an interview, Biden outlines his post-White House plans for accelerating progress against cancer. He plans a nonprofit organization to focus on many of the "moonshot" issues including data sharing and clinical trials.

    Jan 5, 2017

  • Hidden Value Found In Short-Lived IBC Trial

    Clinical Informatics News | A recent short-lived trial testing inflammatory breast cancer has helped shed new light on the implications of genomic evolution in clinical trials, especially as it pertains to trial design.

    Jan 5, 2017

  • Why Leveraging Technology Is The Key To Improving Healthcare

    Forbes |  Technology is vital if the healthcare industry wants to continue to improve the quality of its services.

    Jan 4, 2017

  • New FDA Drug Approvals Breaking Down the Numbers

    RAPS |  If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010. But maybe that's not all bad.

    Jan 4, 2017

  • 21st Century Cures Act Clarifies (And Somewhat Reduces) Regulation of Stand Alone Software Products Used In Healthcare

    FDA Law Blog |  This post focuses on only one section of the new law: Section 3060, "Clarifying Medical Software Regulation."

    Jan 3, 2017

  • Gates Foundation Sends $140M to Intarcia for HIV Version of Pump

    Xconomy |  Intarcia Therapeutics, a Boston biotech that's developing a tiny, implantable drug-delivery pump for type 2 diabetes, is now broadening its focus to HIV backed by as much as $140 million from the Bill & Melinda Gates Foundation.

    Dec 29, 2016

  • Amyloid Hypothesis For Alzheimers In Doubt After Lillys Drug Failure

    NPR.org |  The failure of an experimental drug that targets clumps of protein inside the brains of Alzheimer's patients called into question one of the leading theories about the cause of the dementia.

    Dec 29, 2016

  • Liver Damage Patient Deaths Lead FDA to Halt SeaGen Leukemia Trials

    Xconomy |  Seattle Genetics' work to develop a drug to treat a form of leukemia has hit a roadblock following the deaths of four patients in clinical trials. The FDA placed a clinical hold or partial holds on three early-stage trials evaluating the company's drug.

    Dec 28, 2016

  • The Case For eConsent Integration

    Clinical Informatics News Contributed Commentary | The introduction of electronic informed consent (eConsent) solutions to communicate study information, while supporting the management of informed consent processes, offers huge improvements to participant on-boarding in today’s clinical trials.

    Dec 27, 2016