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UA Cancer Center To Join National Clinical Trial Research Group
Arizona Daily Star | The University of Arizona Cancer Center has been accepted into a national clinical trials research group. The University's physicians will provide input on research studies, and integrate their own ideas.
Nov 14, 2016
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FDA, CluePoints Sign CRADA
Clinical Informatics News | Last month CluePoints and FDA signed a CRADA, Cooperative Research and Development Agreement, to enhance data integrity in clinical trial submissions to the FDA using CluePoints software.
Nov 9, 2016
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FDA to study how promotional tweets for drugs should convey side effects
STAT | Drug makers and their marketing partners argue the FDA social media policies have failed to keep up with technology.
Nov 9, 2016
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As Election Storm Gathered, Arrowhead Drops Word About A Clinical Hold
ENDPOINTS NEWS | As everyone's attention was being commanded by the big presidential vote Tuesday night, Arrowhead Pharmaceuticals chose to put out word that its lead program has been put on hold by the FDA.
Nov 9, 2016
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Building A Culture Of Innovation In Healthcare
Forbes | Innovation in healthcare is notoriously tricky, but the Children's Hospital of Philadelphia are one organization that have got it nailed. CHOP are attempting to continue a track record of success with the creation of a new post of Vice President for Entrepreneurship & Innovation last year.
Nov 8, 2016
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FDA Releases Recommendations for Handling Race & Ethnicity in Clinical Trials
Clinical Informatics News | The FDA recently released a guidance with the purpose of offering suggestions to researchers conducting clinical trials on how to handle issues as they pertain to race and ethnicity, especially a kind of standardization for collecting and reporting race and ethnicity data.
Nov 8, 2016
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FDA Officials: There Was “No Scientific Basis” For Duchenne Drug OK As Sarepta Complained Of “Dire Financial” Condition
Endpoints News | Two senior FDA officials mounted a vehement assault on Janet Woodcock's decision to push through an approval of Sarepta's Duchenne muscular dystrophy drug Exondys 51. New documents posted by the FDA, including a round of memos on the issue in September, warned FDA Commissioner Robert Califf that he was allowing an approval even though Woodcock had not considered all the analysis they had done to underscore the company's weak case, adding that there was no scientific basis to conclude that the drug was reasonably likely to benefit patients.
Nov 4, 2016
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What clinical trial results? Now you can see who isnt sharing their findings
STAT | A tracker was launched by a group of researchers and medical journals that has been pushing the pharma industry to do a better job of disclosing trial data.
Nov 3, 2016
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Why The Approach To Drug Pricing Has To Change Now
Forbes | As an industry, we must shift to a model that focuses on value and outcomes delivered, both to patients and to health systems.
Nov 2, 2016
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Litmus Health Seeks Alternative In Data Gathering For Clinical Trials
Clinical Informatics News | Litmus Health recently launched into public beta at the University of Chicago. The data science platform has ambitions to make “the entire world will be one big clinical trial.”
Nov 2, 2016
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Cures Bill in Jeopardy Amid Drug Pricing Push
The Hill | A coalition of liberal groups has come out against passage of the measure this year, further putting its future in doubt.
Nov 1, 2016
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In Defense of Data Sharing But Done In The Right Way
STAT | If data are collected using standards that are compatible with each other, they will be more easily shared and provide the greatest return.
Oct 31, 2016
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Large Molecule Clinical Trials Taking Longer, Costing More
Outsourcing-Pharma | Significant differences in large molecule clinical trials highlights the need to be more efficient, according to a recent analysis of clinical trial duration.
Oct 31, 2016
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23andMe Reaches Enrollment Goal for Lupus Research
23andMe | 23andMe and Pfizer are collaborating on a lupus trial. The two have enrolled 5,000 people with autoimmune disease, and hope to use genetic and survey data to learn more about the genetics of lupus.
Oct 28, 2016
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Comparing Drug And Medical Device Clinical Trials
MassDevice | Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important. A well-organized, controlled clinical trial can save time and money. Additionally, the faster and more accurately a trial is performed, the faster the test article can be introduced to the market and begin helping the community.
Oct 28, 2016
