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Most results from e-cigarette trials improperly reported, or not reported at all

Journal
Tobacco Control
Reuters Health - 18/06/2021 - Of five clinical trials listed on ClinicalTrials.gov and sponsored by JUUL Labs, only one resulted in a published paper and none had results posted on the government trial registry, a case series study finds.

Based on the trial registry data, the UK-based researchers argue in Tobacco Control, the five trials ought to be covered by the U.S. Food and Drug Administration (FDA) Amendments Act 2007, which among other things requires reporting results directly to ClinicalTrials.gov within a year of study completion.

Instead, the researchers found one publication and four poster presentations for four of the five registered trials. Even the content in these reports, such as pre-specified outcomes, fell short of U.S. and international standards, the study team notes.

"The take-home message is that we need clearer mechanisms in place to ensure that tobacco industry trials are being reported promptly and completely to avoid the potential for bias in the evidence base," said Nicholas DeVito, a doctoral student at the DataLab at the Nuffield Department of Primary Care Health Sciences at the University of Oxford.

"It appears that while a company like JUUL will put trial results out there in the public domain they may not always tell the full story of the trial," DeVito said in an email. "Even choosing to publish some trials as papers and others as just conference abstracts or posters has the potential to lead to selective outcome reporting. Complete reporting to a registry like ClinicalTrials.gov can avoid this issue entirely."

To take a closer look at the reporting of results from trials supported by JUUL, DeVito and his colleagues searched ClinicalTrials.gov in August of 2020 to assess whether each had data fields consistent with coverage under FDAAA 2007 and to see whether the data had been made available to the public.

The researchers excluded one trial (NCT04452175) because JUUL Labs was a collaborator and not the primary sponsor. Five further trials were excluded as their registrations were inconsistent with potential FDAAA coverage (NCT04143256, NCT04123041, NCT04107779, NCT04088175 and NCT03700112). None of these excluded trials had results available on ClinicalTrials.gov, and only NCT03700112 was completed for over a year as of 1 August 2020.

Five registered trials were consistent with the Final Rule's 'Applicable Clinical Trial' criteria. All were interventional and affirmed that they were on an 'FDA-regulated device product.'

DeVito and his team noted that none of the five trials had results reported to ClinicalTrials.gov, but the researchers did locate conference posters containing results for four of the five trials on the JLI Science website, a JUUL-supported database, and one publication in the literature that reported more in-depth results from one of the posters. Three of the posters were available less than a year from the trial's primary completion date.

In the posters and the publication, only brief methods are provided, none completely reported all pre-specified outcomes, and none disclosed any changes to specified outcomes, the study found. Overall, just 28 of 61 (46%) pre-specified outcomes across all five trials were reported or properly declared, and eight (13%) additional outcomes were reported but with issues. By outcome type, 15 of 23 (65%) primary outcomes and 13 of 38 (26%) secondary outcomes were properly accounted for in any results reports.

The researchers noted problematic outcomes that involved either examining specific levels of molecules arising from tobacco use in various contexts (for example, urine, breath, room air, plasma) or using subjective measures. Among the eight outcomes that were reported with issues, six measured specific molecules and two were subjective scales; and among the 24 missing outcomes, 11 were examining molecule concentrations and nine were subjective measures.

There is already a problem with implicit bias in research on e-cigarettes as an aid in smoking cessation, said Dr. Panagis Galiatsatos, an assistant professor in the division of pulmonary and critical care medicine and director of the Tobacco Treatment Clinic at Johns Hopkins Medicine in Baltimore.

"If you're getting funding from these companies, it's hard to bite the hand that feeds you," Dr. Galiatsatos said. "I think there's probably a place for e-cigarettes in the social world. But if you want to bring them into the world of medicine to make it seem as if they are a therapeutic intervention, you'd better be prepared to objectively allow research to prove they work. The companies never did that. Their goal is more capitalistic and they scream, scream, scream when they are not accepted as a therapeutic intervention."

SOURCE: https://bit.ly/35DGsK9 Tobacco Control, online June 14, 2021.

By Linda Carroll



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