clinical trials
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The First 3D Printed Organ -- A Liver -- Is Expected In 2014
Approximately 18 people die every day waiting for an organ transplant. But that may change someday sooner than you think -- thanks to 3D printing. Read More »
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The Holy Grail Of New Drug Development
The announcement by Zydus Cadila in early June that their new drug to treat diabetics who also suffer from high cholesterol has passed all stages of clinical trials is an important landmark for the Indian pharmaceutical industry. [...] Read More »
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The ONC 10 Year Vision
On June 5th 2014, ONC released “Connecting Health and Care for the Nation: a 10-Year Vision to Achieve an Interoperable Health IT Infrastructure." The plan is divided in 3 year goals, 6 year goals, and 10 year goals. Five specific tactics support the strategies. Below is a summary of the report and a few comments from my Massachusetts experience that support the reasonableness of the ONC goals.
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The Open Medicine Institute: Big Plans And A Sense Of Urgency
Imagine that you’ve just been put in charge of the world’s ME/CFS research – yes, you – and you’ve got to decide what research you want. Come on, hurry up! Read More »
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The Ransomware Attacks on Hospitals Are (Cyber) Criminal
One of the redeeming aspects of crises is that, amidst all the confusion, suffering, and loss, there are usually moments of grace, of humans showing their best nature... Unfortunately, crises also tend to bring out the worst of our natures... And then there are the cyberattacks. Last week the federal Cybersecurity & Infrastructure Security Agency, the FBI, and HHS issued a joint alert Ransomware Activity Targeting the Healthcare and Public Health Sector, warning that they have "credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers." I'll spare you the technical details of the expected attack strategies or suggested mitigation efforts, but I will note that they warned: "CISA, FBI, and HHS do not recommend paying ransom." Read More »
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This Woman Invented A Way To Run 30 Lab Tests On Only One Drop Of Blood
Phlebotomy. Even the word sounds archaic—and that’s nothing compared to the slow, expensive, and inefficient reality of drawing blood and having it tested. As a college sophomore, Elizabeth Holmes envisioned a way to reinvent old-fashioned phlebotomy and, in the process, usher in an era of comprehensive superfast diagnosis and preventive medicine. Read More »
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Thomson Reuters Launches New Clinical Trial Intelligence Solution
Cortellis Clinical Trials Intelligence enables users to accelerate clinical trial development decisions and portfolio strategy Read More »
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Three Areas Where Health Information Technology Needs to Get its House in Order
Health reform is taking off, thanks to pressure from insurers, the promise with which innovative technologies tease us for low-cost treatments, and regulatory mandates dating back to the HITECH act of 2009. Recent hopeful signs for wider adoption of health technologies include FDA forebearance from regulating consumer health apps, calls for more support for telemedicine, and new health announcements from tech giants such as Apple and Google. While technologists push forward in all these areas, we need to keep in mind that several big unsolved problems remain. Let's not get lost in the details--these major issues have to be tackled head on. Read More »
TransCelerate BioPharma Inc. Releases First Update On Risk-Based Monitoring Of Clinical Trials Initiative, Yields Key Lessons And Training Materials
In its continued effort to modernize and streamline the way clinical trials are conducted and monitored, TransCelerate BioPharma Inc. ("TransCelerate") is providing the first update to its position paper outlining a methodology for risk-based site monitoring ("Risk-Based Monitoring" or "RBM") released in June 2013. Read More »
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TransCelerate Shares Its Take On Risk-Based Monitoring Models And Tech
With clinical trial sponsors spending a sizable chunk of their huge Phase III trial budgets on source data verification (SDV) in return for questionable benefits, risk-based monitoring is an obvious target for TransCelerate BioPharma's R&D efficiency agenda. The Big Pharma consortium has further clarified its thinking on the topic in two research papers...
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Trial Designed With Crowd Input Gets FDA Signoff
What's been called the first clinical study protocol developed using crowdsourcing methods received the FDA's imprimatur earlier this month. The agency approved Transparency Life Sciences' IND for a clinical trial designed to test a generic blood-pressure medication, ACE inhibitor lisinopril, in patients with relapsing remitting multiple sclerosis. Read More »
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Two Drug Firms Experiment With Use of Apple's ResearchKit
Two major pharmaceutical companies are using Apple's ResearchKit open-source project in experiments aimed at helping medical researchers gain more data and fresh insights as they seek ways to battle human diseases and illnesses. Pharmaceutical company GlaxoSmithKline confirmed its work in a July 10 tweet, saying the company is "looking @ Apple's #ResearchKit for clinical trials," while Purdue Pharma also said it is exploring early possible uses of ResearchKit in its own drug research, according to a July 12 story by Buzzfeed. Read More »
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Universal Language: The Pistoia Alliance Takes on Indescribable Biology
Best Practices WinnerThe Pistoia Alliance has previously sponsored new methods for querying databases and the scientific literature, and a more effective algorithm for compressing and sharing genetic sequencing data. Over the past year, another Pistoia project, HELM, has entered the public domain after gradual development by an assortment of Alliance members. An open source language and set of editing tools for working with large biomolecules, HELM has already become a foundational part of research in at least three large pharmaceutical companies. Read More »
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Using Patient-centered Technology To Improve Recruitment And Retention
Sponsors of clinical research must increasingly focus on improving patient engagement in order to meet many of today’s research challenges. Promising disruptions are already under way that could define new models for patient recruitment and retention. Read More »
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VA's Palo Alto Hospital Selects Bitscopic's PraediAlert Clinical Surveillance Platform
Bitscopic Inc., a Silicon Valley based healthcare analytics company, announced today that the US Department of Veteran's Affairs (VA) Palo Alto Medical Center has selected Bitscopic's PraediAlert platform for clinical surveillance. PraediAlert is an FDA registered clinical surveillance system that allows hospitals to improve patient care and patient safety by minimizing and managing patients at risk for hospital acquired infections (HAI) as well as optimizing care team productivity and workflows to improve patient outcomes.
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