More questions are being raised about SPRINT, the enormous NIH-funded blood pressure lowering trial. Two recent developments will likely add more obstacles to the already difficult task of applying the results of the trial in the real world. Even before the full results of the trial were first made public the NIH and the SPRINT…
Statin Trialists Seek To Bury Debate With Evidence
September 8, 2016 by 14 Comments
–A Lancet review claims overwhelming evidence in favor of statins for both primary and secondary prevention. Some disagree. A large group of statin researchers argue forcefully that the debate over statins should be ended because the evidence in favor of statins is overwhelming and incontrovertible. But some outsiders say the issue is more nuanced and…
Clinical Trialists Dig In And Vote For Status Quo
August 5, 2016 by Leave a Comment
–Doctors who got famous for doing clinical trials resist changes to the clinical trial system. It should probably come as no surprise that hundreds of clinical trial investigators whose positions and livelihoods depend largely on the existing clinical trial system have expressed great reluctance and annoyance at a proposal that could radically shake up that system. As…
Top Clinical Investigators Seek To Dampen Impact Of Data Sharing
August 3, 2016 by 3 Comments
Despite earlier concerns by its editors about “data parasites,” the New England Journal of Medicine has now published 4 articles offering support in some form for data sharing. But two of the articles— written by many of the most prominent clinical trial researchers in the United States and Canada— express grave concerns about data sharing…
No Evidence To Support Screening Young Athletes
April 20, 2016 by Leave a Comment
–More questions raised about key study suggesting ECG screening can save lives There is no good evidence to support screening young athletes to prevent sudden cardiac arrest, concludes a new analysis published in the BMJ. The analysis also raises new and troubling questions about a key Italian study that has been the main study used…
Editors Deliver Major Victory To Open Data Movement
January 20, 2016 by Leave a Comment
The open data movement has gained its biggest victory yet. In an editorial published simultaneously in 14 major medical journals today, The International Committee of Medical Journal Editors (ICMJE) delivered a full-throated endorsement, in both actions as well as words, of data sharing by clinical researchers. Here is the core of the ICMJE proposal: As…
Buried Clinical Trial Data: The Dam Is About to Burst
January 14, 2015 by Leave a Comment
Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials. … a preliminary report from the prestigious Institute of Medicine lends strong support to the open data movement. The IOM report states that investigators should be required to establish a data-sharing plan at the…
Johnson & Johnson Will Share Clinical Trial Data
January 30, 2014 by 1 Comment
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 from investigators and physicians seeking access to…
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