Medidata Solutions, Tessella, Merck
News Friday, June 29.
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 results of an ongoing trial to redirect it in midstream—have daunting operational issues in an industry burdened by paper in every process, every aspect of a trial. But there are also non-trivial regulatory worries. Those were the topic of a webinar last month. Sponsored by electronic data capture company Medidata, the online presentations attempted to summarize (or perhaps telepathically channel) European and U.S. regulatory thinking. It’s clear that while publicly touting the merits of new trial techniques such as adaptive designs, regulators have in an unknown number of instances been forced to say “no” when assessing specific protocols. …more...
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.…more...
October 23, 2007
Adaptive trials are very much on the minds of the clinical trial community, with a few big sponsors like Novartis and Merck plunging into the systems necessary to support them. Many…more...
August 31, 2007
Clinical data standards seem wonderful in the abstract. On a white board, the work of CDISC and HL7 should make life easier, cheaper and faster for everyone involved in any clinical trial, just as broccoli should be good for anybody’s health. Thinking about buying broccoli is more common than buying it. That’s surprising, given the FDA’s encouragement…more...
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 in the clinical ointment. Adaptive trials will,…more...
July 20, 2007
In the world of running, the ultramarathon is anything longer than a 26-mile course. Some people run from one rim of the Grand Canyon, down to the bottom, and up to the other rim. And back. In a day. They call that an “R2R2R.” Adaptive designs are the ultramarathons of clinical trials. Adaptive designs will test even…more...
July 18, 2007
SEC Associates, a regulatory consultancy, announced it has completed a three-day workshop to train the FDA on the intricacies of electronic clinical trials. In addition to describing basic functionality of core systems used in clinical trials, specific attention was given to how these systems are designed, tested, maintained and integrated by the pharmaceutical, biotech and medical device…more...
News Friday, June 29.
The leading biostatistical house and a top EDC vendor say they have a better way to move clinical data toward analysis.
An expanding ClinPhone, with a headquarters in the UK and major offices in the U.S., talks about a new product and its overall strategy.
Briefs for Tuesday, June 5.
Despite a cautious attitude for pricing EDC, Phoenix Data Systems is thriving. A recent announcement from the company noted customers signing up for four pivotal Phase III trials.
News bulletins for Friday, April 27.
A few news bulletins for Tuesday, April 24.
Info & Opinion
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