May 27, 2019adaptive

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 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...

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.…more...

Guidance On Schedule

FDA’s Wilson On Adaptive Paths

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...

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…more...

Adaptive trials, ePRO, more

PDF, Quick-Start Tools From Almac

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...

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 in the clinical ointment. Adaptive trials will,…more...

The ClinPage Checklist

22 Questions For Adaptive Trials

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...

Cytel, NERI, Pharsight

Wednesday News Bulletins

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...

Medidata Solutions, Tessella, Merck

News Briefs

News Friday, June 29.

Follow the Metadata

SAS, Medidata Partner

The leading biostatistical house and a top EDC vendor say they have a better way to move clinical data toward analysis.

Unified Interface By Next Year

ClinPhone’s ‘Compact,’ Adaptive Push

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.

Octagon, invivodata, Adaptive trials

News Briefs

Briefs for Tuesday, June 5.

Adaptive EDC

Phoenix Data Systems: Sustainable Growth

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.

Clinipace, INC Research

News Briefs

News bulletins for Friday, April 27.

PHT, etrials, Zyprexa

News Briefs

A few news bulletins for Tuesday, April 24.

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