The ARBITER 6-HALTS study investigating Zetia and Niaspan was stopped early, confounding the outcome and likely inflating the efficacy of Niaspan. There was no ethical reason to stop the trial early. It is quite possible that there would have been no benefit to Niaspan whatsoever if the trial were carried out to completion.
Dr. Gordon Guyatt discusses the statistical reasons that clinical trials should not be stopped early, in most cases. Early stoppage has been a growing problem in the cardiology and oncology trials.
Gordon Guyatt, MD, epidemiologist, internist, and biostatistician at McMaster University updates us on the progress being made against the problem of clinical trials being stopped early to inflate efficacy of drugs. Since our first coverage of the topic two years ago, the FDA, the Cochrane group, and other agencies have implemented changes in policy. Dr. Guyatt discusses the Crestor JUPITER trial as an example of a trial that was stopped early and inflated efficacy.
In full screen 1080i HD for better viewing of the data graphics
and NBC’s egregious coverage
Produced and interviewed by Steven Greer, MD
Meta-analyses and other forms of systematic reviews of the medical literature to determining comparative effectiveness have grown in prevalence and prestige over the last decade. PCORI, AHRQ, The Cochrane Group, medical societies, and many other organizations have their own efforts to create reviews of clinical therapies. Not surprisingly, for-profit entities have also hijacked the process the create research to suit their needs.
In Part 1, Dr. Guyatt explains why this systematic reviews have grown, and discusses the major established guidelines for conducting such reviews. He mentions AMSTAR and The Cochrane Handbook as the best resources, in his opinion.
In Part 2, Dr. Guyatt mentions how the process for meta-analysis can be manipulated to create junk science data.
The HCC interviewed Dr. Gordon Guyatt to discuss the major flaws in the way the Crestor JUPITER trial was conducted and reported.