• BMS Opens Clinical Data

    PM Live | Bristol-Myers Squibb has agreed to make full clinical study reports and anonymized patient-level data public via the Duke Clinical Research Initiative (DCRI).

    Jun 27, 2014

  • REACTing to the Trial Big Picture: AstraZeneca and Tessella Collaborate on Drug Safety Platform

    Clinical Informatics News | Twenty percent of Phase II clinical failures from 2008-2010 were because of drug safety issues, making safety not only a concern to the patient, but huge cost driver for drug developers. So AstraZeneca and their partner, Tessella, built REACT, a better tool to watch ongoing trials. The solution won the pair a 2014 Bio-IT World Best Practices Award in Clinical & Health IT.

    Jun 27, 2014

  • In Clinical Trials, Small is Beautiful

    Clinical Informatics News | As clinical trials are ballooning in size and becoming more global, there is a parallel trend toward smaller and smaller. How about a clinical trial with just one subject?

    Jun 26, 2014

  • GSK Under Fire for Recruiting Broke College Grads

    Clinical Informatics News | GlaxoSmithKline is raising questions about clinical trial recruitment after an outside consultant (who has since been fired) posted a blog post to a website for recent college graduates touting clinical trials as a source of “immediate income that can tide you over for the coming months”.

    Jun 23, 2014

  • Unpacking the Clinical Genome

    Clinical Informatics News | The Clinical Genome Conference, now in its third year, was held in San Francisco June 10-12. The program explored a wide range of issues facing genomics in the clinic including the payer process, genome interpretation software, clinical utility and integration, references and standards, and communicating findings to the patient. Here are some of the highlights from the event.

    Jun 23, 2014

  • FDA Releases Social Media Draft Guidances

    Clinical Informatics News | The FDA has finally released two draft guidances on how companies should deal with social media including comments posted on Twitter and third party blogs and sponsored links on search engines such as Google and Yahoo.

    Jun 17, 2014

  • Updated DIA News and New Products

    Clinical Informatics News | Lots of product news coming out of the Drug Information Association annual meeting that started today in San Diego. Here are some of the highlights.

    Jun 16, 2014

  • May-June Clinical News and Product Briefs

    Clinical Informatics News | Clinical news and product releases from around the industry, including Eli Lilly's new clinical trial transparency commitments, and Aptiv Solutions' latest adaptive dose response software for Phase 1 clinical trials.

    Jun 13, 2014

  • Public Databases Aim to Match Myriad's Closely-Held Knowledge of BRCA Mutations

    Nature News | In the effort to empower clinical geneticists with reliable public data on which genetic variants should be labeled pathogenic, mutations to the breast cancer-related BRCA1 and BRCA2 genes have been among the heaviest points of contention.

    Jun 11, 2014

  • Novartis Acknowledges Huge Lapse in Clinical Trial Safety Reporting

    WSJ Pharmalot | Following revelations in April that Novartis employees in Japan had concealed unfavorable safety reports in clinical trials, the pharmaceutical company has now disclosed that the problem was much more widespread than was previously realized.

    Jun 11, 2014

  • Health Data for All: Maximizing Health Data for Both Business and Patient

    Clinical Informatics News | Transparency, data sharing, and the inclusion of patient voices were all major themes at last week's Healthdatapalooza event in Washington, D.C.

    Jun 9, 2014

  • Geisinger to Open Telemedicine Center for Genetic Testing

    Clinical Informatics News Brief | Geisinger Health Systems, one of the country's largest provider networks, yesterday announced the construction of a new facility in Forty Fort, PA, to provide patients with remote consultations around DNA diagnostics.

    Jun 6, 2014

  • A Dramatic Case of Clinical Pathogen Detection through Gene Sequencing

    New York Times | A new, ultra-rapid method of pathogen detection from DNA samples has been used to diagnose, and ultimately cure, a life-threatening case of encephalitis that had led doctors to place a 14-year-old boy in a medically induced coma.

    Jun 5, 2014

  • European Ombudsman Shares Her Views of Ongoing EMA Transparency Controversy

    WSJ Pharmalot | Ed Silverman, whose popular Pharmalot blog was revived this week in a new home at the Wall Street Journal, has published an interview with European Ombudsman Emily O'Reilly about her criticisms of the European Medicines Agency.

    Jun 5, 2014