• FDA Alerts on Risks From Merck’s Keytruda in Multiple Myeloma Following Halted Trials

    RAPS |  Today, FDA released an alert and summary findings from two halted Merck clinical trials evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma.

    Aug 31, 2017

  • Clinerion, Novartis, RxEOB, And More: News From August 2017

    Clinical Informatics News | August was full of exciting news in the clinical trial and healthcare community, including partnerships and products from Clinerion, Novartis, RxEOB, and more.

    Aug 31, 2017

  • Survey Says: Subtle Shifts In Trial Startup Challenges

    Clinical Informatics News | A survey of 100, qualified respondents seeking insight into the trends in clinical trial patient enrollment and recruitment reveals subtle shifts in clinical trials startup challenges.

    Aug 29, 2017

  • Peter Thiel Funds 'Unethical' Offshore Herpes Vaccine Trial

    The Daily Beast |  The Trump adviser is part of a group of wealthy businessmen spending millions to test the vaccine on people-while evading Food and Drug Administration regulations.

    Aug 28, 2017

  • Patients Not Always Informed Of Study's Purpose In Noninferiority Trials

    RAPS |  A study published in JAMA Internal Medicine this week finds that patients participating in noninferiority trials for antibiotics are not always accurately informed of the purpose of the study, based on an analysis of informed consent forms.

    Aug 24, 2017

  • Disrupting Clinical Operations With CRO Strategic Partnerships

    Clinical Informatics News Contributed Commentary | As the CRO industry adapts to be more budget minded and efficient, the quest for innovation remains. So, what does meaningful innovation look like for the clinical trial industry?

    Aug 24, 2017

  • Data Sharing: Stakeholder Perspectives On Transparency In Clinical Trials

    Clinical Informatics News Contributed Commentary | Calls for greater transparency and open data access in clinical research—with its promise to benefit researchers, innovation, and patients—continue actively. Providing access to individual patient data from other investigators, researchers, and the public creates new value in multiple areas.

    Aug 22, 2017

  • Engineering The End Of Malaria

    Pacific Standard |  Intellectual Ventures has put some of the profits from licensing patents into developing breakthrough health-care technologies that nobody else has been able to pursue.

    Aug 21, 2017

  • Clinical Trials Need More Minorities In Them

    The Washington Post |  Minorities go underrepresented in important research efforts. Given the nation's changing demographics, it's neither good health policy nor good business to be developing drugs and possible cures that are tested in only a subset of the population.

    Aug 21, 2017

  • The Future Of Clinical Trial Protocols: Where Is The Industry Headed?

    Clinical Informatics News Contributed Commentary | The most important component of this process is the clinical trial protocol. Considerable time is spent trying to locate information and interpret the different ways critical protocol elements are described or defined. This sometimes lead to delays, errors, and sometimes both.

    Aug 18, 2017

  • FDA Expectations For Diversity Inclusion In Clinical Research

    Clinical Informatics News Contributed Commentary | FDA expects sponsors to enroll study participants who reflect the demographics of clinically relevant populations for their product with regard to age, sex, race, and ethnicity. In reality, however, current clinical trial populations do not reflect the true demographics and disease prevalence in the United States.

    Aug 15, 2017

  • Oracle Offers New Set Of Microservices With Clinical One Platform

    Clinical Informatics News | After years of development, Oracle Health Sciences has released the Clinical One platform, which offers tools for security, identity management, performance, disaster recovery, and availability.

    Aug 10, 2017

  • Proposed and Final FDA Rules What’s Left in 2017

    RAPS |  The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings.

    Aug 9, 2017