January 14th, 2015
Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials. In recent years, in response to troubling and far-reaching questions about the availability and reliability of clinical trial data, reformers have called for new policies that would require drug companies and other […]
March 29th, 2014
SYMPLICITY HTN-3, the eagerly awaited first rigorous test of renal denervation, shows that the real effect of the novel blood-pressure-lowering technology is dramatically lower than earlier expectations, which had been fueled by data from previous uncontrolled trials. Results of SYMPLICITY HTN-3 were presented at the American College of Cardiology conference in Washington, DC, and published simultaneously […]
January 30th, 2014
In a major victory for advocates of open access to data from clinical trials, Johnson & Johnson today announced that it will make all of its clinical trial data available to outside researchers. The company said that the Yale University Open Data Access (YODA) Project will serve as an independent third party “to review requests […]
November 21st, 2013
Michael S. Lauer discusses his article titled “The Randomized Registry Trial — The Next Disruptive Technology in Clinical Research?”
November 6th, 2013
The following post is by Matt Herper, who covers science and medicine for Forbes magazine. When a panel of experts appointed by the Food and Drug Administration said the agency should deny Amarin Pharmaceuticals a broader marketing approval for its fish oil pill Vascepa, the company’s shares tanked 60%, making it the worst-performing biotechnology stock on […]
September 16th, 2013
Ultimately, we need clinical trials to know what drugs and medical devices work. Without them, we will not have the evidence we need for clinical practice guidelines, and clinical care will not evolve. But traditional clinical trial approaches are not sustainable – too expensive and too inefficient. The new hope for clinical trials is to […]
April 11th, 2013
Treatment of Heart Failure with Preserved Ejection Fraction: Why Have All the Clinical Trials Failed, and What Can We Do About It?
Laying out a road map for better trials and ultimately better outcomes for this confounding condition
April 9th, 2013
Gervasio Antonio Lamas, MD, Daniel Mark, Christine Goertz, DC, PhD, Robin Boineau, M.D., M.A., Kerry L. Lee, Ph.D. and Harlan M. Krumholz, MD, SM
The publication in JAMA of the NIH’s Trial to Assess Chelation Therapy (TACT) has reignited a heated debate about the trial. The TACT investigators have generously agreed to respond to questions posed by Harlan Krumholz.
April 2nd, 2013
The NIH TACT trial of chelation therapy has been the subject of intense criticism. In my opinion, the arguments that the TACT results are dubious or not valid are overstated. While the debate surrounding TACT is clearly warranted and welcome, I hope it generates more light than heat.
September 4th, 2012
Larry Husten is back from ESC and discussing two trials that exemplify how medicine is supposed to work, and one that exemplifies what can go wrong, especially when commercial interests are at stake.