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Mini-Sentinel Assessments

September 22, 2014 Mini-Sentinel is a pilot project sponsored by the U.S. Food and Drug Administration (FDA) to create an active surveillance system – the Sentinel System – to monitor the safety of FDA-regulated medical products. Most Mini-Sentinel activities focus on assessments, methods, or data. Visit the following links to learn more about each type … Continue reading Mini-Sentinel Assessments

FDA releases action plan to encourage greater patient diversification in trials

The FDA has released an action plan aimed at encouraging more diverse patient participation in drug and medical device clinical trials.

The plan, released last month, lays out priorities for increasing both trial participation and the reporting of patient demographic data. It follows an August 2013 report to Congress on these concerns.
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In the News: 5 Q’s for Sarah Greene, Senior Program Officer at PCORI

Published on September 2, 2014 | by Daniel Castro, Center for Data Innovation The Center for Data Innovation spoke with Sarah Greene, a senior program officer at the Patient-Centered Outcomes Research Institute (PCORI), a non-profit organization authorized by Congress to fund and disseminate research that will help patients and caregivers make more informed decisions. Greene … Continue reading In the News: 5 Q’s for Sarah Greene, Senior Program Officer at PCORI

In the News: For Big-Data Scientists, ‘Janitor Work’ Is Key Hurdle to Insights

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Technology revolutions come in measured, sometimes foot-dragging steps. The lab science and marketing enthusiasm tend to underestimate the bottlenecks to progress that must be overcome with hard work and practical engineering.
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In the News: US big-data health network launches aspirin study

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PCORI clinical-research initiative will collect information on some 30 million people. Sara Reardon, Nature.com; 06 August 2014 One of the largest big-data experiments in health care has set its first research target. The leaders of the Patient-Centered Outcomes Research Institute (PCORI) in Washington DC voted on 29 July to focus the institute’s first clinical trial … Continue reading In the News: US big-data health network launches aspirin study