• Orphan Drug Approval Process Inefficient, Confusing

    Clinical Informatics News | Last year was the first time that all of the orphan drugs approved by FDA—17 total—took advantage of the Priority Review option. But Priority Review is only one of four options available to developers of orphan compounds for expedited FDA review. In a paper published in September in The Journal of Rare Disorders, authors posit that this indicates that the options are neither fully understood by orphan drug companies nor are not being used optimally by them.

    Dec 7, 2015

  • New Draft Guidance on Best Practices for IND Communications Between Sponsors FDA

    RAPS |  Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of new best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday.

    Dec 7, 2015

  • Should DNA donors see their genomic data?

    Nature News & Comment |  Geneticist Charles Danko turned to Twitter this week for help in convincing his IRB at Cornell that he should be allowed to let his study participants download their genetic information

    Dec 4, 2015

  • Sangamo Cleared by FDA to Begin First Gene Editing Clinical Trial

    New Scientist |  Sangamo BioSciences' gene editing therapy for hemophilia B, based on zinc finger nuclease technology, can go forward in the first study of such a therapy in humans.

    Dec 4, 2015

  • Death by Flaming Water Ski, and Other Misfortunes

    The New Yorker |  As care providers roll out ICD-10 codes for health problems, the lengthy and highly specific list is cause for both mirth and contemplation.

    Dec 4, 2015

  • November Clinical News and Product Briefs

    Clinical Informatics News | News and product launches from around the industry, including a cancer genomics project in San Antonio, and autism research in the Illumina cloud.

    Dec 3, 2015

  • Cures Within Reach Calls for 100 Drug Repurposing Projects

    Clinical Informatics News | With a new web portal for connecting researchers and funding sources, Cures Within Reach is doubling down on enabling successful drug repurposing research. The new 100 Projects in 100 Days initiative hopes to gather 100 proposed drug repurposing projects before mid-February, partly to prove the richness of the opportunity.

    Dec 3, 2015

  • Flaws and Failings in the Priority Review Voucher System for Neglected Disease

    STAT |  The US government tried to incentivize drug makers to produce new and effective treatments for neglected diseases, but the approach hasn't gone according to plan.

    Nov 30, 2015

  • 21st Century Cures Act Would Have Let Failed Alzheimer's Drugs Slip Through

    FierceBiotech |  The National Center for Health Research warns that the 21st Century Cures Act, now under consideration by Congress, would open substantial loopholes for ineffective drugs - reflecting on how three failed Alzheimer's drugs would have fared if the act had been in effect.

    Nov 24, 2015

  • The Importance of an eCOA Device Supply Strategy in Global Clinical Trials

    Clinical Informatics News | Contributed Commentary | Over the past decade, electronic Clinical Outcome Assessment (eCOA) has become increasingly popular in global clinical trials thanks to the technology’s ability to provide more complete data collection, boost compliance, and manage patients in real-time. Despite its proven record in supporting clinical trials of all sizes and complexities, many sponsors and CROs still have reservations about implementing eCOA. 

    Nov 23, 2015

  • Optimizing the Pipeline: Making Genomics In the Clinic a Reality

    Clinical Informatics News | Today HudsonAlpha held the grand opening for the Smith Family Clinic for Genomic Medicine, a collaboration between the HudsonAlpha Institute, the University of Alabama at Birmingham; and Children's of Alabama, a pediatric medical center.

    Nov 20, 2015

  • CLARITY Challenge Results Show Disparity in Reporting

    Clinical Informatics News | Results are in for the CLARITY Undiagnosed challenge, a crowdsourced competition sponsored by the Manton Center for Orphan Disease Research at Boston Children's and the Department of Biomedical Informatics (DBMI) at Harvard Medical School.

    Nov 18, 2015

  • Speeding Study Startup Through Better Collaboration and Data Flow

    Clinical Informatics News Contributed Commentary | A critical question facing many sponsors and contract research organizations is whether another system to support study startup is really needed. It’s a fair question in the clinical world where the urgent need for better execution of clinical trials has led to a proliferation of technologies, namely the clinical trial management system; the electronic trial master file; electronic data capture; and others. Each of these solutions focuses on specific pieces of the clinical trial continuum, yet, they overlook aspects unique to SSU, a complex process that continues to stumble and stall clinical trial timelines.

    Nov 16, 2015

  • Clinical Decision Alerts Poorly Tailored to Purpose in Opioid Prescriptions

    EHR Intelligence | A study in Annals of Emergency Medicine has shown that clinical decision alerts designed to prevent adverse events from opioids have extremely low specificity, presenting doctors with over 120 unnecessary alerts for every one adverse event prevented.

    Nov 13, 2015

  • Drug makers kept many clinical trial results a secret study

    Pharmalot |  In a study of 318 clinical trials, 35% of results were not disclosed. Glaxo, J&J, and Pfizer were the most transparent pharma companies, releasing all of the trial data for drugs approved in 2012. Gilead Sciences and Sanofi disclosed the least trials.

    Nov 12, 2015