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December 3, 2008
CDASH Webinar Tomorrow
Carbonic e-Case Report Forms
Rhonda Facile of CDISC talks about the CDASH effort to standardize case report forms. The first public release is due soon.
Report Blames FDA
GAO: Elderly Trial Data Lacking
The GAO says the FDA and sponsors aren’t doing enough to analyze clinical trial data about the elderly.
New Diabetes Endpoints?
NEJM Hits Post-Approval Trials
Is the FDA a new target of the New England Journal of Medicine? Maybe. Late last month, the journal has an article by the head of the Avandia advisory committee that casts a skeptical eye on observational trials.
When Speed Means Slow
Rozwell on Data Standards (Podcast #1)
Gartner distinguished analyst Carol Rozwell talks about drug safety, contract research organizations, data mining and other topics related to CDISC standards.
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The good news is: cloning works. The catch? You have to rethink your most cherished and convoluted case report forms (CRF). Barely two years ago, CDISC president Becky Kush, the well-travelled and uber-diplomatic Henry Kissinger of the clinical trial realm,…
Data about the elderly aren’t properly represented in clinical studies, and the aged may be at risk when they take prescription drugs. That was the upshot of Prescription Drugs: FDA Guidance and Regulations Related to Data on Elderly Persons in…
Concerns about diabetes blockbuster Avandia have been addressed by the mass media, by FDA statements—and by the August 30, 2007, New England Journal of Medicine (NEJM). It’s not a surprise that the journal would have a negative view of the…
The Clinical Data Interchange Standards Consortium (CDISC) does not want for savvy high-energy volunteers or high-profile member organizations. For evidence of that, just hang out at CDISC’s user meeting, which is coming up in October. There’s just one problem. Using…
Despite the fact that some European biotechs have been touting microdosing as the next big thing, sponsors in the U.S. are still not rushing out in great numbers to give the extremely low-dose trials a whirl. In fact, says the…
Pacific Edge Biotechnology (PEB) announces that it has signed a collaborative research agreement with the international Ludwig Institute for Cancer Research. PEB, an Otago University start-up, said it was developing a number of novel tools and methods for the early…
Clinical trial technology suite Phase Forward has renewed its alliance with Parexel, a contract research organization. The multi-year agreement allows Parexel to continue to offer Phase Forward’s InForm electronic data capture (EDC) product as an integral part of its solution…
Former deputy FDA commissioner Scott Gottlieb left the agency not long ago, returning to the American Enterprise Institute (AEI). Since leaving FDA, the prolific Gottlieb has written a large number of essays and articles for a variety of publications. We’ve…
Genelabs Technologies announces that it had reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase III clinical trial of Prestara for treatment of systemic lupus. Relsys International, a provider…
