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Clinical Trials Still Don't Reflect the Diversity of America
NPR.org | Clinical trials are too white, with less than 2 percent of cancer studies including enough minority people to provide information that could be useful for health, a study finds.
Dec 16, 2015
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PerkinElmer, TIBCO Announce Clinical Data Review Product
Clinical Informatics News | PerkinElmer announced a new analytics solution yesterday built with TIBCO Spotfire designed to help review teams, biostaticians, data managers, pharmacologists and others overcome clinical data review challenges.
Dec 15, 2015
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Federal Law Requiring Disclosure of Clinical Trial Results Is Routinely Flouted
STAT | A STAT analysis has found that many of the nation's top research institutions are not reporting clinical trial results as required by law.
Dec 14, 2015
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Novo Nordisk, IBM Watson Health to Create ‘Virtual Doctor’
Wall Street Journal | Novo Nordisk is teaming up with IBM Watson Health, a division of IBM, to create a "virtual doctor" for diabetes patients that could dispense treatment advice such as insulin dosage.
Dec 11, 2015
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Small-Scale Violations of Medical Privacy Often Cause the Most Harm
ProPublica | Breaches that expose the health details of just a patient or two are proliferating nationwide. Regulators focus on larger privacy violations and rarely take action on small ones, despite the harm.
Dec 11, 2015
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What’s Missing From Your Social Media Clinical Trial Recruitment Strategy
Clinical Leader | As social media becomes a permanent fixture in patients' lives and pharmaceutical companies' business strategies, companies are turning to social media to recruit patients. Here's what a social media recruitment strategy should include.
Dec 9, 2015
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Bill creating more orphan drugs would cost consumers billions
STAT | A 21st Century Cures Act provision allowing more medicines to receive orphan drug status will cost consumers billions of dollars, an analysis says.
Dec 8, 2015
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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
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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
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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
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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
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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
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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
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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
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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
