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October 12, 2008
Nudging By FDA
FDA-Ready Graphs From Insightful
Inspired by Web 2.0 tools that foster sharing and collaboration, Insightful Software released new software to generate charts and graphs in a regulated setting.
Conference Preview
Daiichi-Sankyo On PRO Math
A Japanese pharma talks about patient diaries and biostatistical concerns.
CRO Sounds Cautionary Note
PharmaNet on Adaptive Designs
Could the best-laid plans for adaptive trials have unexpected results?
CRO Revenue Impact?
Adaptive Trials Insights From UBC
United BioSource talks about resources (its own and others) for adaptive trials.
Adaptive Logistics
Linking Clinical Trial, Supply Simulation
Cytel and Tourtellotte Consulting join forces to design trials and drug supply needs for adaptive protocols.
United BioSource (UBC) has been built one acquisition at a time from a 9-figure investment war chest. The company provides clinical trial research services, but is not a contract research organization (CRO) in any traditional sense. It counts some CROs as customers and calls itself a specialty services organization. With… more...
The math of adaptive trials is hairy. But the appeal is simple. Adaptive trials can reveal the optimal dose in a single trial—not six. They can identify dud drugs early. The approach can require significantly smaller sample sizes and save big companies billions of dollars. There’s just one mathematical fly… more...
In the world of running, the ultramarathon is anything longer than a 26-mile course. Some people run from one rim of the Grand Canyon, down to the bottom, and up to the other rim. And back. In a day. They call that an “R2R2R.” Adaptive designs are the ultramarathons of… more...
In the movies, scientists scour databases to find what they need in a few keystrokes. In the real world, it’s surprising just how limited and narrow most clinical trial databases are. They hold the data from a single trial, a single type of lab equipment. Connecting one database to something… more...
We have an actual scoop. As an old magazine guy on a bimonthly schedule, we had almost forgotten how to handle the situation. We were forced to duck into our local public library and consult one of those dusty journalism texts. It seems that at the ExL Clinical Supply Forecasting… more...
ClinPage has drunk the Kool-Aid about adaptive designs. We think they could forever alter the timelines and budgets of entire portfolios of clinical trials. But there is hardly a technology we don’t like. Cable TV, perhaps. On the other hand, there is skepticism about adaptive trial designs. It boils down… more...
Later this week, on Thursday, the electronic data capture firm TrialStat! and biostatistical software house Cytel’s Jerald Schindler, president of that company’s Pharmaceutical Research Division, will be participating in a webinar on EDC and adaptive trials. ClinPage will moderate the discussion. You can sign up here. It’s free. As we’ve… more...
If clinical data moves along an assembly line, it’s a lurching and circuitous one, with stops and interruptions along the way. The final product of that assembly line is almost always a SAS file. Many in the industry are wondering which stations on the assembly line are eternal, obligatory—and which… more...
It is utterly impossible to pigeonhole Dr. Jerald Schindler. We’ve tried. Schindler confounds the three easiest caricatures that any self-respecting journalist would reach for. Schindler is a biostatistician, but speaks fluidly, lucidly. He’s a vendor, but leaves his Cytel sales pitch in the overhead luggage bin on the plane to… more...
We’ve heard a few presentations from Genzyme about Pompe disease, a rare respiratory and musculatory disorder afflicting one in 40 to 300,000 people. (It’s an “orphan” condition, and Genzyme’s intravenous drug, Myozyme, was approved for Pompe disease in infants in April, 2006.) But we had not been previously aware that… more...
