Placebo Control

A review of key issues in pharmaceutical clinical trials

Thursday, January 12, 2012

Changing the Rules, Ever So Slightly, For Rare Diseases

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At the end of last year, US Reps Cliff Stearns (R-FL) and Ed Towns (D-NY) introduced the Unlocking Lifesaving Treatments for Rare-Diseases A...
Wednesday, January 4, 2012

Public Reporting of Patient Recruitment?

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A few years back, I was working with a small biotech companies as they were ramping up to begin their first-ever pivotal trial. One of the ...
Tuesday, June 28, 2011

DDMAC to weigh in on trial design?

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The FDA Law Blog has an incredibly interesting entry regarding last week's Untitled Letter from the FDA's Division of Drug Marketin...
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