by Kaplan RM and Irvin VL.PLoS One. 2015 10[8]:e0132382.
BACKGROUND: We explore whether the number of null results in large National Heart Lung, and Blood Institute [NHLBI] funded trials has increased over time.METHODS: We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality.RESULTS: 17 of 30 studies [57%] published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 [8%] trials published after 2000 [χ2=12.2, df= 1, p=0.0005]. There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings.CONCLUSIONS: The number NHLBI trials reporting positive results declined after the year 2000. Prospective declaration of outcomes in RCTs, and the adoption of transparent reporting standards, as required by clinicaltrials.gov, may have contributed to the trend toward null findings.
Kind of a cute and telling study. The National Heart Lung, and Blood Institute plotted the standardized outcome [Relative Risk of the Primary Outcome] against the year of the study for all their funded studies from 1970 to 2014. Look what happened when ClinicalTrials.gov came along in 2000 and they started preregistering their Primary Outcome Variables a priori. Made honest scientists out of them! Speaking of cute, the article that pointed me to it said, "Preregistration of clinical trials causes medicines to stop working!"
sorta offtopic dr. nardo, but i’m wondering if, back in the day, you’d heard of an american psychiatrist named hudson haogland?
it surprises me that he is not as well known as he should be, given his contributions in the field. i figured since i’m relatively young (turned 29; still, no spring chicken) and that he lived from 1900-1982, maybe you’d heard of him during your days in residency.
http://www.nytimes.com/1982/03/05/obituaries/hudson-hoagland-pioneered-in-studies-of-the-brain-s-waves.html
i thought that, since there were no comments related to the crazy-corruption that has overrun our field, i’d take this moment to revisit one (if not the only) of your country’s most important psychiatrists (it’s very hard to practice legit psychiatry, let alone making notable contributions that advance the field)
i found his science (“Science and the new Humanism”) article to be extremely moving and inspiring: http://science.sciencemag.org/content/143/3602/111
(
“gosh, he’s so young”, the onlookers say to themselves quietly.
i know guys, i know. hopefully we’re past this point by now, but who knows
)
IMO dr hoagland is long overdue for enshrinement in the american science canon.