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FDA and NIH let clinical trial sponsors keep results secret and break the law | Science | AAAS
The University of Texas MD Anderson Cancer Center and the Mayo Clinic both failed to report results on time, or at all, in about two-thirds of their trials. Yale University failed to do so in 84% of its trials. NIH’s own institutes also had a bad record. They are directly responsible for reporting results when they sponsor studies done by agency staff or some grantees, and the top four NIH institute sponsors, taken together, reported results late or not at all in more than six of every 10 trials Science looked at.
Contacted for comment, none of the institutions disputed the findings of this investigation. In all 4768 trials Science checked, sponsors violated the reporting law more than 55% of the time. And in hundreds of cases where the sponsors got credit for reporting trial results, they have yet to be publicly posted because of quality lapses flagged by ClinicalTrials.gov staff (see sidebar).
NEJM Journal Watch: Summaries of and commentary on original medical and scientific articles from key medical journals
Rivaroxaban (Xarelto) and apixaban (Eliquis) are the most commonly prescribed direct-acting oral anticoagulants (DOACs) in the U.S., but no head-to-head comparisons are available to guide physicians' choices between these drugs. In this study, researchers used a large U.S. claims database to compare the effectiveness and safety of rivaroxaban and apixaban in patients with newly diagnosed venous thromboembolism (VTE). About 3000 apixaban users were compared with about 12,000 propensity-score-matched rivaroxaban users.
During average follow-up of about 3 months, recurrent VTE occurred significantly less often in apixaban users than in rivaroxaban users (3 vs. 7 events per 100 person-years). Major bleeding also occurred significantly less often with apixaban (3 vs. 6 events per 100 person-years). These findings were consistent across various subgroups.
Persistence of Contradicted Claims in the Literature | Dementia and Cognitive Impairment | JAMA | JAMA Network
For the 2 vitamin E epidemiological studies, even in 2005, 50% of citing articles remained favorable. A favorable stance was independently less likely in more recent articles, specifically in articles that also cited the HOPE trial (odds ratio for 2001, 0.05 [95% confidence interval, 0.01-0.19; P < .001] and the odds ratio for 2005, 0.06 [95% confidence interval, 0.02-0.24; P < .001], as compared with 1997), and in general/internal medicine vs specialty journals. Among articles citing the HOPE trial in 2005, 41.4% were unfavorable. In 2006, 62.5% of articles referencing the highly cited article that had proposed beta-carotene and 61.7% of those referencing the highly cited article on estrogen effectiveness were still favorable; 100% and 96%, respectively, of the citations appeared in specialty journals; and citations were significantly less favorable (P = .001 and P = .009, respectively) when the major contradicting trials were also mentioned. Counterarguments defending vitamin E or estrogen included diverse selection and information biases and genuine differences across studies in participants, interventions, cointerventions, and outcomes. Favorable citations to beta-carotene, long after evidence contradicted its effectiveness, did not consider the contradicting evidence.
The Influence of Industry Sponsorship on the Research Agenda: A Scoping Review
Corporate interests can drive research agendas away from questions that are the most relevant for public health. Strategies to counteract corporate influence on the research agenda are needed, including heightened disclosure of funding sources and conflicts of interest in published articles to allow an assessment of commercial biases. We also recommend policy actions beyond disclosure such as increasing funding for independent research and strict guidelines to regulate the interaction of research institutes with commercial entities.
How a data detective exposed suspicious medical trials
After seeing so many cases of fraud, alongside typos and mistakes, Carlisle has developed his own theory of what drives some researchers to make up their data. “They think that random chance on this occasion got in the way of the truth, of how they know the Universe really works,” he says. “So they change the result to what they think it should have been.”
How a data detective exposed suspicious medical trials
One problem, several researchers in the field say, is that funders, journals and many in the scientific community give a relatively low priority to such checks. “It is not a very rewarding type of work to do,” Nuijten says. “It’s you trying to find flaws in other people’s work, and that is not something that will make you very popular.”
Can CBD Really Do All That? - The New York Times
Realm of Caring, still run by Heather Jackson, is already doing this in partnership with academic researchers, sharing data from a 55,000-person registry that includes information on what people are using cannabis for and what side effects and benefits they see.
Why clinical trial outcomes fail to translate into benefits for patients | Trials | Full Text
We highlight problems with trial outcomes that make evidence difficult or impossible to interpret and that undermine the translation of research into practice and policy. These complex issues include the use of surrogate, composite and subjective endpoints; a failure to take account of patients’ perspectives when designing research outcomes; publication and other outcome reporting biases, including the under-reporting of adverse events; the reporting of relative measures at the expense of more informative absolute outcomes; misleading reporting; multiplicity of outcomes; and a lack of core outcome sets.
