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May 12, 2008

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.

The ClinPage Checklist

22 Questions For Adaptive Trials

As life science organizations consider adaptive clinical trial designs, the process, technology and operational aspects are complex. What to consider.

Cambridge Silo Killers

Rethinking Data Warehouses at Waban

Can your clinical data warehouse combine genotyping data, clinical data and demographic data? And analyze it in a reproducible way? A conversation with Waban.

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Webinar: Tessella, United Biosource

Adaptive Designs: The Regulatory Issues

February 15, 2008

For the all the excitement and anticipation around adaptive designs for clinical trials, there’s always been one pesky fly in the ointment. Do regulators actually bless adaptive approaches when sponsors propose them? Has hype inflated expectations for such a promising technique? Adaptive trials—which include a statistical regimen to use the… more...

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Harvard Prof On Stats Shifts

Pssst! Need To Change An End Point?

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… more...

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Nudging By FDA

FDA-Ready Graphs From Insightful

December 18, 2007

How fast can your company analyze its clinical data? If a medical journal says your data are incomplete on a Thursday morning, is the turnaround time for your response a) one month b) six months or c) “it depends”? In an era of withering scrutiny of clinical research, biostatisticians are… more...

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Conference Preview

Daiichi-Sankyo On PRO Math

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… more...

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CRO Sounds Cautionary Note

PharmaNet on Adaptive Designs

October 24, 2007

As we noted in an article yesterday, the annual Regulatory Affairs Professionals Society (RAPS) meeting, held last month in Boston, had a fascinating session on adaptive designs from a regulatory perspective. Another speaker was Mary Johnson, executive VP of biostatistics at PharmaNet. That contract research organization offers a unified platform… more...

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CRO Revenue Impact?

Adaptive Trials Insights From UBC

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… more...

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Adaptive Logistics

Linking Clinical Trial, Supply Simulation

August 06, 2007

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...

more Statistics stories...