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China To Tighten Rules Against Faking Clinical Trial Data, Criminal Charges Possible
FierceBiotech | China's FDA and Supreme Court, in a seemingly synchronized move, are proposing new actions against forging clinical trial data, and criminal charges are on the table.
Apr 13, 2017
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New Report Charts Ways To Expedite Critical Research During Epidemics
STAT | The report recommends ways to accelerate clinical trials for future epidemics, hoping to ensure that the lessons from the Ebola outbreak are not forgotten.
Apr 12, 2017
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PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals
RAPS | The Pharmaceutical Research and Manufacturers of America (PhRMA) last week said it supports the US Food and Drug Administration's (FDA) review of its inspection information flow, particularly as applications that receive on-time inspections typically receive first cycle approvals earlier.
Apr 11, 2017
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Navigating A Connected World: Sensors In Clinical Trials And Care
Clinical Informatics News | Novartis is hoping to answer the vast questions that surround connected sensor data, and how it might be used to improve drug development, clinical trials, and patient care.
Apr 10, 2017
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FDA Delays eCTD Requirements for Master Files
RAPS | The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format.
Apr 7, 2017
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It’s About Time: Clinical Trial Visit Simulations
Clinical Informatics News | It's About Time | Highlighting new ideas for advancing clinical research, Norman Goldfarb speaks with Faye O’Brien from the Global Medicines Development at AstraZeneca about the need to start simulating clinical trial visits.
Apr 5, 2017
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Journal Editor Calls For Culture Change Around Clinical Trial Data
STAT | A summit convened by NEJM sought to determine the right balance between sharing data from clinical trials and keeping them private.
Apr 4, 2017
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Shortcuts In Drug Testing Can Increase Risk To Patients
NPR.org | Researchers use intermediate endpoints, like how a drug lowers cholesterol, to get a quick sense of whether the drug might improve health. But those shortcuts often don't show true benefits and harms.
Apr 4, 2017
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Move Over Las Vegas: How To Improve The Odds Of Late-Phase Clinical Trial Success
Clinical Informatics News Contributed Commentary | The transition from phase 2 to phase 3 of a clinical trial has a very low success rate. Modeling and simulation technologies may serve as pivotal tools for reducing late-stage attrition.
Apr 4, 2017
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For Bristol-Myers A Victory And A Mystery
Forbes | In a relief to investors, the combination of Opdivo and Yervoy extends survival in melanoma. But to understand why Opdivo did not show a benefit in previously untreated lung cancer, we may need to look more closely at trial design and diagnostic tests.
Apr 3, 2017
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The FDA Does Not Care About Health Apps So the Courts Stepped Up
WIRED | Last week, the New York Attorney General's office settled lawsuits forcing three app developers to stop promising health-tech miracles.
Apr 3, 2017
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CluePoints, PAREXEL, goBalto, And More: News From March 2017
Clinical Informatics News Brief | News, products, and partnerships from around the clinical trial and healthcare community including news from CluePoints, PAREXEL, goBalto, and more.
Mar 31, 2017
