Weekly Features

New data mapping software zeroes in on anomalies, trends

Monday, March 27, 2017

With thousands of data points collected in nearly every clinical trial, tech companies have been working to develop new ways to help teams sort out critical information. Recently, CluePoints announced the launch of Patient Profiles, a highly configurable platform that prioritizes atypical data, in an effort to help teams focus on at-risk study participants.

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Industry reacts to proposed regulatory fee increase

Monday, March 27, 2017

President Trump’s proposed budget would require drug and device makers to pay more than double the current fees for regulatory approval, a concern that has many in the industry asking for more detail. The proposed budget posits the fee increases would improve the speed of regulatory approval, but specifics for how that outcome would be achieved have yet to be provided. The suggested budget also cuts nearly $6 billion from the NIH, which would greatly impact medical research funding.

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Keapstone Therapeutics created as new virtual biotech for Parkinson’s

Monday, March 20, 2017

The University of Sheffield and Parkinson’s UK have combined forces to create Keapstone Therapeutics. The goal of the newly formed company is to help move research into nuclear factor erythroid 2-related factor 2 (Nrf2) through the development process and, hopefully, into testable treatments for Parkinson’s disease. Parkinson’s disease affects around 1 million people in the U.S. and 127,000 in the U.K.

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Multi-sponsor trial results website launches

Monday, March 13, 2017

It wasn’t that long ago that patients just wandered away after a clinical trial wrapped up, never learning the results of the trial, never knowing whether or not their participation made any difference.

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Sanofi bets on virtual clinical trials

Monday, March 13, 2017

The clinical research industry is facing a crisis. Nearly 80% of trials do not meet enrollment timelines, and these delays can amount to $8 million in lost revenue per day, according to one estimate by Cutting Edge Information. But now the industry is betting on a new trend: virtual clinical research.

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GSK’s real world study exemplifies trial design of the future

Monday, March 6, 2017

Using a novel trial design, GlaxoSmithKline (GSK) has conducted a study in Salford, U.K., using real-world data in patients with chronic obstructive pulmonary disease (COPD). The study used an electronic data-monitoring system to notify physicians immediately of any adverse events. The phase IIIb, open-label, randomized controlled trial (RCT) of Relvar lasted four years and enrolled almost any patient with COPD who wanted to participate, without the limitations on age and health status commonly placed on medication trials. Indeed, over one-half of the patients in Salford with COPD were recruited into the trial, which included 2,800 patients across 80 general practices.

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