• A Realist Looks At AI In Clinical Trials

    Clinical Research News | When assessing new technologies for clinical trials, one needs to be both visionary and skeptical. That seems to be even more true for AI technologies.

    Jan 28, 2019

  • FDA Announces New Guidances Focusing On Risk Evaluation And Mitigation Strategy

    Clinical Research News | The FDA's commissioner, Scott Gottlieb, released a statement today announcing the availability of two guidances that will help improve the agency’s ability to ensure that the risk mitigation programs put in place for certain drugs and biologics as a requirement of their approval are working.

    Jan 24, 2019

  • Aetna, Anthem, HCSC, PNC Bank, IBM To Establish Blockchain-Based Ecosystem For Healthcare Industry

    Clinical Research News Brief | Aetna, Anthem, Health Care Services Corporation (HCSC), PNC Bank, and IBM today announced a new collaboration to design and create a network using blockchain technology to improve transparency and interoperability in the healthcare industry.

    Jan 24, 2019

  • Modernizing Clinical Trials For Patients With Cancer

    JAMA Network | In this Viewpoint, directors at the National Cancer Institute (NCI) review reforms to the NCI clinical trials program, including use of historical controls and a push to reduce the financial pressures of clinical trials.

    Jan 24, 2019

  • Temperature-Stable Experimental Tuberculosis Vaccine Enters Clinical Testing

    National Institutes of Health (NIH) | Vaccinations have begun in a Phase 1 human clinical trial testing a freeze-dried, temperature-stable formulation of an experimental tuberculosis (TB) vaccine candidate.

    Jan 23, 2019

  • What Is Holding Back The Adoption Of eConsent?

    Clinical Research News | The eConsent field is challenging: on the one hand it represents a major improvement in the consenting process for clinical trial participants. On the other hand, it is fraught with regulatory uncertainties and industry ambiguity. Tearing apart this tangle will be necessary for eConsent to do what the technology is meant to do: inform trial participants and speed enrollment.

    Jan 23, 2019

  • 3 Blockchain Apps Up For Adoption In 2019

    Clinical Research News | A trio of blockchain-enabled applications that debuted at the recent Distributed: Health conference in Nashville, Tennessee, could start giving patients more control over their personal health data as early as next year.

    Jan 22, 2019

  • Clinical Research News: New Title, Broader Focus

    Clinical Research News | For more than 15 years, the team behind Clinical Informatics News has been covering technology and trends in the clinical research space. Now, we are announcing a new name and brand to better reflect that broad and passionate scope: Clinical Research News.

    Jan 21, 2019

  • FDA Exploring New Approach To Software Oversight

    Clinical Informatics News | A trio of new FDA documents released January 7 suggests the agency is trying to create a new oversight paradigm for Software as a Medical Device (SaMD) that is better aligned to the realities of software development without updating existing regulations or issuing new ones.

    Jan 18, 2019

  • Another Tool In The Toolbox: AI’s Application In Clinical Trials

    Clinical Informatics News | The promise of AI’s impact on clinical trials has many experts both bewildered and skeptical. A panel at the AI World Conference & Expo looked past the hype and discussed practical application.

    Jan 17, 2019

  • Safety And Multivigilance: From Cost Center To Cost Saver

    Clinical Informatics News Contributed Commentary | Safety departments see themselves as invaluable protectors of patients’ health and well-being, while other departments often view these groups as necessary for compliance, but also cost centers that are expensive and slow down processes. So which view is correct?

    Jan 16, 2019