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NIH Notice: Revised definition of “Clinical Trial”

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The NIH has revised its definition of “clinical trial.” The revision is designed to make the distinction between clinical trials and clinical research studies clearer. It is not intended to expand the scope of the category of clinical trials. Notice of Revised NIH Definition of Clinical Trial (NOT-OD-15-015) National Institutes of Health

There’s a Giant Job Ahead for Big Data

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U.S. News & World Report, Kate Green, posted 10-3/14 Can analytics produce better outcomes? PCORI’s Joe Selby and Rachael Fleurence are featured in this article highlighting PCORnet as a leader in the movement to use electronic health records and other data sources to improve medical treatment. Read the full article …

Design Power: Patients Play Researchers in Drug Trials

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Scientists regularly sign up patients in clinical trials to test new treatments. Now, they are seeking patients to help them design some of those trials.

Patients and researchers can bring different perspectives to treating disease. In a trial of a potential prostate-cancer drug getting underway at the Icahn School of Medicine at Mount Sinai in New York, doctors had planned to ask patients periodically about side effects such as nausea. But patient input convinced them to ask additional questions, including how many days patients felt well enough to go to work.
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Free the Data announces new partnership with Rep. Debbie Wasserman Schultz

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WASHINGTON, DC. Posted: October 8, 2014, Free-the-Data.org Congresswoman continues her dedication to advancing medical research and improving care for hereditary breast and ovarian cancer Free the Data, a national coalition of organizations dedicated to freeing genetic information, today announced that U.S. Rep. Debbie Wasserman Schultz (FL-23) has been named its Honorary Chair. “The time for … Continue reading Free the Data announces new partnership with Rep. Debbie Wasserman Schultz

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