JAMA Network | JAMA | Open Access to Clinical Trials Data

abernard102@gmail.com 2014-09-12


Use the link to access the full text editorial from JAMA.  "Well-conducted randomized clinical trials (RCTs) are the gold standard for evaluating the safety and efficacy of medical therapeutics. Yet most often, a single group of individuals who conducted the trial are the only ones who have access to the raw data, conduct the analysis, and publish the study results. This limited access does not typically allow others to replicate the trial findings ... In this issue of JAMA, Ebrahim et al4 report their findings based on a rigorous search of previously published reanalyses of RCTs. Their first surprising and discomforting finding was just how infrequently data reanalysis has occurred in medical research. Searching the literature from 1966 to present, the authors found only 37 reports that met their criteria as an RCT reanalysis. Of these few reanalyses performed, the majority (84%) had overlapping authors from the original report. Thus, reanalyses are not only rare, but the majority that were reported were not fully independent of the original research group. Despite this overlap, Ebrahim et al report that about half of the reanalyses differed in statistical or analytic approaches, a third differed in the definitions or measurements of outcomes, and most important, a third led to interpretations and conclusions different than those in the original article ... Even when the original investigators are presenting evidence in different venues it is not always consistent. For example, there is evidence from trials that data presented to the US Food and Drug Administration (FDA) may differ in important ways from those originally presented at scientific sessions or published in medical journals. Rising et al5 assessed clinical trial information provided to the FDA and reported a 9% discordance between the conclusions in the report to the FDA and in the published article. Not unexpectedly, all were in the direction favoring the drug.  Another example is discordance between what is reported in ClinicalTrials.gov and what is published in journal articles. Hartung et al2 showed that in a random sample of phase 3 and 4 trials, in 15% the primary end point in the main article was different from the primary end point the trialists reported in ClinicalTrials.gov. Moreover, 22% reported the primary outcome value inconsistently, with some even having differences in the number of deaths. Other studies have found similar rates of discordance ..."



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Date tagged:

09/12/2014, 07:27

Date published:

09/12/2014, 03:27