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...

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...

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...

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...