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September 7, 2008
Harvard Prof On Stats Shifts
Pssst! Need To Change An End Point?
A biostatician with deep NIH and FDA ties talks about general guidelines for changing primary end points. Plus, the M-word.
Atkinson Comes From Within
PPD Gets New VP
Susan Atkinson will head up global biostatistics and data management for the Wilmington, N.C.-based CRO.
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Not long ago, on a bleak winter morning when the U.S. Congress and the New York governor and the Connecticut attorney general and the second most important medical journal were trashing the industry, we banged out an email to Scott…
Wilmington, N.C.-based contract research organization (CRO) PPD has a new senior vice president of global biostatistics and data management. It’s Susan Atkinson, who previously oversaw the company’s Phase I-IV biostatistics, programming and data management for U.S. operations. In her the…
The U.S. House of Representatives passed PDUFA legislation by a huge 403-16 vote. The bill includes fines as high as $50 million. The bill would raise $393 million in user fees from the pharmaceutical industry and $287 million from the…
When (and how) should clinical trial endpoints be changed? The open-source journal PLoS Clinical Trials has a fascinating article on the topic. The author is Scott Evans, a biostatistician at Harvard. He notes some journal editors would like to move…
etrials Worldwide, a provider of eClinical software and services that optimize clinical trial management, announced that it has signed a contract with an undisclosed U.S.-based pharmaceutical company. Solutions and services provided by etrials will enable the company to capture, manage,…
