Tag Archives: Clinical Trials

The European Medicine Agency’s Transparency Dilemma

By Peter O’Donnell, Applied Clinical Trials. The European Medicines Agency thought it might at last be back on the road to salvation when Guido Rasi swept into town in 2011 and started ordering greater transparency in the agency’s operations. He was determined to seek a new type of trust with the agency’s various publics—and particularly […]
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European Regulator’s Last Ditch Attempt at Transparency

By Peter O’ Donnell. The European Medicines Agency is determined to minimize opposition to its next moves on releasing clinical trial data. It announced last week yet another consultation on its plans to publish the results of trials — a policy it initially aimed at introducing from the beginning of this year. The latest twist […]
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After Delays, Project DataSphere Rolls Out

An industry and academic data-sharing project went live on Tuesday, nearly a year after the platform was expected to launch. Visitors to the site – no credentials needed – can register and access de-identified clinical data from the comparator arms of nine oncology trials, with more to come. Project DataSphere, the newest data transparency and […]
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Clinical Trials in the Digital Age

In 1995, there were 16 million internet users — or 0.4% of the world’s population. In just 17 years, this figure has grown to 2.4 billion and 34.3% adoption. At the current rate, each year, the penetration percentage sees a 2–4% growth. Many services, such as banking, have moved towards online service models, shutting down branch […]
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Is Gender a Drug Safety Issue in the Era of Personalized Medicine?

By Lisa Henderson, Applied Clinical Trials. In January 2013, FDA told manufacturers to lower the dose of zolpidem, the insomnia treatment, for women, and suggested a 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). That was based on evidence […]
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