Links
Organizations
Conferences
Info & Opinion
July 20, 2008
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.
Linking Tools for Supply, Randomization
An Adaptive Partnership
Cytel and Tourtellotte consulting have integrated two important applications.
Fast-Track Status
Napo Proclaims Adaptive Design
In describing a new Phase III trial, Napo Pharmaceuticals touts its adaptive approach. Will other sponsors stoke investor interest using the anticipation surrounding adaptive trials?
Rescue Firm
TrialStat! Touts Usability, Speed
The Canadian EDC supplier offers a true zero-footprint offering, with benefits in speed and user-friendliness. The company believes it is especially well-positioned to handle trials in different regulatory jurisdictions.
Every trial has them: planning, execution and analysis. Within those three steps, one wrong move is accompanied by surprisingly steep penalties. An entirely new study or set of studies may need to be designed and executed. Take one example. Bringing the wrong dosage into Phase III can result in terminating… more...
Could the pharmaceutical industry manage clinical data more intelligently, using software to go toe to toe with Steve Nissen of the Cleveland Clinic? Would such tools ensure more consistent communications with regulatory bodies? Properly executed, could better software even deflect a meta-analysis cooked up in academia? The answer from SAS… more...
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...
