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New research study supports need for transparency in clinical trials

Likelihood of Null Effects of Large NHLBI Clinical Trials Increased over Time (PLOS One): – “…Beginning in approximately 2000, the likelihood of showing a significant benefit in large National Heart Lung, and Blood Institute (NHLBI) funded studies declined. Among the explanations we evaluated, the requirement of prospective registration in Clinicaltrials.gov is most strongly associated with the observed trend toward null clinical trials. The decline is not easily explained by the increased use of active comparators or a decline in industry sponsorship. In addition to the explanations at we evaluated using reported characteristics of the trials, we considered several other suggestions…n conclusion, null findings in large RCTs may be disappointing to investigators, but they are not negative for science. Properly powered trials might identify treatments that will improve public health. A growing collection of trials suggests that promising treatments do not match their potential when systematically tested and transparently reported. Publication of these trials may lead to the protection of patients from treatments that use resources while not enhancing patient outcomes. For example, a recent economic analysis of the Women’s Health Initiative clinical trial suggested that the publication of the study may have resulted in 126,000 fewer breast cancer deaths, and 76,000 deaths from heart disease between 2003 and 2012. The economic analysis estimated that there was about $140 returned for each dollar invested in the study. Transparent and impartial reporting of clinical trial results will ultimately identify the treatments most likely to maximize benefit and reduce harm.”

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