• EMA Makes Concessions to Transparency Advocates Over Release of Clinical Study Reports

    PharmaTimes | The European Medicines Agency (EMA) has finalized its policy on clinical study transparency, following an April vote of the European Union to require all clinical trial results to be openly published.

    Oct 3, 2014

  • September Clinical News and Product Briefs

    Clinical Informatics News | News and product releases from around the industry, including the ATHENA study of Alport syndrome, and a customizable patient portal for results from genome sequencing.

    Oct 2, 2014

  • Personal Attention for Regular Hospital Visitors

    Kaiser Health News | The Camden Coalition of Healthcare Providers is conducting a long-term clinical trial to test whether giving personal "coaching" attention to the heaviest users of hospital systems will reduce readmissions and improve patient wellbeing.

    Oct 1, 2014

  • Big Results for Perjeta are Big Boost for Personalized Medicine

    Clinical Informatics News Brief | The CLEOPATRA study, which began recruitment in 2008 for an 800-patient clinical trial of the antibody therapy Perjeta in breast cancer, has just released its results, showing an incredible survival gain of nearly 16 months.

    Sep 29, 2014

  • Health Policy Advocates Protest Auction of .health Internet Domain

    Clinical Informatics News | The Internet Corporation for Assigned Names and Numbers, the Los Angeles-based nonprofit that sets global policy for Internet domain names, plans to shortly auction off the rights to sell health-related top-level domain names, including .health, a scheme that is drawing protests from medical and public policy organizations.

    Sep 26, 2014

  • FDA's Sentinel Project Advances from Pilot Stage

    Nature News | The Sentinel Initiative, launched in 2008, aims to collect adverse event reports from electronic health records and insurance claims databases, giving the FDA an additional tool to monitor the safety characteristics of drugs and medical devices after they reach the market.

    Sep 24, 2014

  • Risk to Patients Balanced Against Risk to Labs as FDA Moves on Lab Developed Tests

    Clinical Informatics News | On September 29, the FDA is set to issue a draft guidance that will, for the first time, subject tests developed and used in single laboratories to FDA oversight. While the agency worries about the risk to patients from unapproved tests, hospital and academic labs fear that the costs of regulation will shut down their most innovative procedures.

    Sep 23, 2014

  • ACRES to Produce Global Accreditation Standards for Trial Sites

    Clinical Informatics News Brief | The Alliance for Clinical Research Excellence and Safety (ACRES), an international group aiming to unite clinical trial sites around the world under common standards and data networks, has announced that it will begin drafting global guidelines for the accreditation of research sites.

    Sep 18, 2014

  • Multiple Myeloma Clinical Trials Kick Into High Gear

    Clinical Informatics News | A year after launching its online research gateways to connect multiple myeloma patients and researchers across the country, the Multiple Myeloma Research Foundation is witnessing a boom in fast-track drug approvals and late stage trials for the disease.

    Sep 16, 2014

  • What Weight Should Oncologists Give to Retrospective Trials of Common Drugs?

    Oncology Live | Maurie Markman, National Director for Medical Oncology at Cancer Treatment Centers of America and editor-in-chief of Oncology Live, writes a thoughtful editorial on the growing number of retrospective studies showing a benefit for common non-cancer drugs in cancer cases.

    Sep 15, 2014

  • Sanger Institute to Implement Real-Time Sequencing in Outbreaks

    The Guardian | After retrospective studies of hospital-centered outbreaks, in which whole-genome sequencing was used to track bacteria with multiple antibiotic resistance, the U.K.'s Wellcome Trust Sanger Institute is planning to recreate this system for use during the course of an outbreak.

    Sep 12, 2014

  • European Pharma, Regulators to Produce Adverse Events App

    In-Pharma Technologist | A team led by the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) and Swiss drug developer Novartis is collaborating on an app that could be used by patients and providers to step up reporting of adverse drug events.

    Sep 9, 2014