Links
Digital Productivity
- Merlin Mann
- Mann's "Inbox Zero" Video
- Black Belt Productivity
- Matthew Cornell
- Lifehacker.com
- Lifehack.org
- David Seah
- Ruthless Email
- Mike St. Pierre
Organizations
Conferences
Info & Opinion
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.
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...
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...
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...
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...
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...
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...
