NiKem Research, Biostatistics, MEDecision
News for June 28.
February 07, 2008
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 Evans. He’s a senior research scientist in Harvard University’s School of Public Health. He teaches biostatistics there, is an advisor to the FDA, and the lead investigator on a few large NIH projects. More than a year ago, Evans authored this cogent peer-reviewed article (it’s also in PDF format) about when it’s appropriate to change primary end points in clinical trials. His analysis remains timely and cogent today, with some sponsors appearing to struggle with the question. A sample quotation from the article: “Revisions to end points (particularly primary end points) should be uncommon. If not appropriately evaluated, such revisions lead to misguided research and suboptimal patient care.” Faith in The…more...
January 22, 2008
Last week, the U.S. Supreme Court declined to hear an appeal of another court’s rejection of the suit brought by The Abigail Alliance for Better Access to Developmental Drugs. We hope…more...
December 21, 2007
If all goes as planned, contract research organization (CRO) Quintiles Transnational will have a new mix of owners come January. On Dec. 21, the company announced that one investor is selling…more...
November 20, 2007
At the end of this month, in Arlington, Virginia, ClinPage will be attending the inaugural Patient Reported Outcome (PRO) conference, sponsored by the Center for Business Intelligence. We’ve long felt the convergence of technological change and regulatory acceptance of PRO warranted a meeting. We can’t wait to attend. One of the speakers at the meeting is Michael…more...
September 11, 2007
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 1,000 employees, UBC reports that more than…more...
September 04, 2007
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 new role, Atkinson is providing direction for the company’s global biostatistics and data management business, including electronic…more...
July 17, 2007
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 medical device industry. The Senate version of the same bill is here. The House version requires sponsors…more...
News for June 28.
Prometrika, a CRO, is adding a clinical-operations arm with the help of a veteran from Nucryst Pharmaceuticals.
A few news bulletins for Monday, April 23.
News bulletins for Friday, April 20.
Obsolescence? Or greater prominence? The recent conference in Florida explored how clinical data managers should prepare for a landscape with more technology.
A discussion about infrastructure for adaptive clinical trials. With process change and the right technology, Cytel‘s Jerry Schindler says, pharma could wring significant savings out of clinical development.
The Illinois company issued a news release that noted it has supported 300 trials since the company’s inception in 1995.
Info & Opinion
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