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FDA Staff Call For Broader Cancer Trial Eligibility Criteria
BioCentury | Richard Pazdur, director of FDA's Oncology Center of Excellence, called for rational approaches to broadening clinical trial eligibility criteria, including enrolling patients aged under 18 in adult trials, to improve cancer studies by capturing the heterogeneity of patient populations that would use therapies after they are approved.
Apr 21, 2017
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Medidata Set To Acquire 2017 Clinical Informatics News Best Practices Award Winner
Clinical Informatics News | 2017 Best Practices Awards | Medidata will acquire Mytrus, who recently won a Best Practices Award in Patient Data Management at the recent Summit for Clinical Ops Executives. Medidata plans to integrate Enroll, Mytrus’ eConsent solution, into the Medidata Clinical Cloud as part of its ongoing commitment to modernize clinical trials for patients, sites, and sponsors.
Apr 20, 2017
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GRAIL Initiates The STRIVE Study To Advance Development Of Blood Tests To Detect Cancer Early
Clinical Informatics News Brief | GRAIL today announced that it has commenced its second multi-center clinical study, the STRIVE Study, to facilitate the development of GRAIL’s blood tests for early-stage cancer detection.
Apr 20, 2017
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Google Offshoot Starts A 10000-Person Study To Plumb Human Biology
Forbes | Verily, formerly known as Google Life Sciences, is launching a long-awaited study whose methods may offer a realistic blueprint for how tech could change medicine. But it's also an emblem of how long that transformation will take.
Apr 20, 2017
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Cures Act: An Important Mile Marker In The Journey To Treat Disease
Deloitte | The recently passed 21st Century Cures Act has the potential to be game changing for the drug and device development and approval process.
Apr 18, 2017
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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
