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Diversity In Clinical Trials: An Issue That We Can No Longer Ignore
MedCity News | Minorities-along with the elderly and women-have historically been underrepresented in clinical trials. FDA Commissioner Robert Califf called 2016 "The Year of Diversity in Clinical Trials." So how have we done?
Jan 6, 2017
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Biden To Tackle Broad Range of Cancer Issues Including Drug Prices After Leaving White House
The Washington Post | In an interview, Biden outlines his post-White House plans for accelerating progress against cancer. He plans a nonprofit organization to focus on many of the "moonshot" issues including data sharing and clinical trials.
Jan 5, 2017
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Hidden Value Found In Short-Lived IBC Trial
Clinical Informatics News | A recent short-lived trial testing inflammatory breast cancer has helped shed new light on the implications of genomic evolution in clinical trials, especially as it pertains to trial design.
Jan 5, 2017
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Why Leveraging Technology Is The Key To Improving Healthcare
Forbes | Technology is vital if the healthcare industry wants to continue to improve the quality of its services.
Jan 4, 2017
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New FDA Drug Approvals Breaking Down the Numbers
RAPS | If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010. But maybe that's not all bad.
Jan 4, 2017
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21st Century Cures Act Clarifies (And Somewhat Reduces) Regulation of Stand Alone Software Products Used In Healthcare
FDA Law Blog | This post focuses on only one section of the new law: Section 3060, "Clarifying Medical Software Regulation."
Jan 3, 2017
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Gates Foundation Sends $140M to Intarcia for HIV Version of Pump
Xconomy | Intarcia Therapeutics, a Boston biotech that's developing a tiny, implantable drug-delivery pump for type 2 diabetes, is now broadening its focus to HIV backed by as much as $140 million from the Bill & Melinda Gates Foundation.
Dec 29, 2016
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Amyloid Hypothesis For Alzheimers In Doubt After Lillys Drug Failure
NPR.org | The failure of an experimental drug that targets clumps of protein inside the brains of Alzheimer's patients called into question one of the leading theories about the cause of the dementia.
Dec 29, 2016
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Liver Damage Patient Deaths Lead FDA to Halt SeaGen Leukemia Trials
Xconomy | Seattle Genetics' work to develop a drug to treat a form of leukemia has hit a roadblock following the deaths of four patients in clinical trials. The FDA placed a clinical hold or partial holds on three early-stage trials evaluating the company's drug.
Dec 28, 2016
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The Case For eConsent Integration
Clinical Informatics News Contributed Commentary | The introduction of electronic informed consent (eConsent) solutions to communicate study information, while supporting the management of informed consent processes, offers huge improvements to participant on-boarding in today’s clinical trials.
Dec 27, 2016
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Almac Clinical Technologies, Commonwealth Informatics, Linguamatics, And Centrexion Therapeutics: News From December 2016
Clinical Informatics News Briefs | News, products, and partnerships from around the clinical trial and healthcare community including news from Almac Clinical Technologies, Commonwealth Informatics, Linguamatics, and Centrexion Therapeutics.
Dec 21, 2016
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FDA Officials Call for Including Adolescents in Adult Oncology Trials
RAPS | A team of officials at the FDA are calling for a "culture shift" by drugmakers, regulators and clinical investigators to encourage enrolling more adolescent patients in relevant "adult-type" cancer clinical trials. The officials made the call in a recent article in Clinical Cancer Research, where they argue that excluding older adolescents, ages 12 to 17, from adult oncology trials leads to delayed access to new treatments for those patients.
Dec 20, 2016
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SCOPE Preview: Clinical Data Strategy, Real World Data, And Precision Medicine
Clinical informatics News | Clinical Informatics News will be attending the Summit for Clinical Ops Executives—SCOPE—in Miami, Fla. from January 24-26, 2017. Here’s some of what we have flagged so far.
Dec 19, 2016
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Obama Signs 21st Century Cures Act Into Law
STAT | President Obama signed the 21st Century Cures Act into law today. Surrounded by Vice President Joe Biden and the bipartisan lawmakers who helped push the bill through, Obama commented, "It's a good day to see us doing our jobs."
Dec 13, 2016
