Florian Naudet

@retractionwatch.com

New post on ResToRes's website :
"When regulators find problems but papers stay silent"
The very first RestoRes study shows that concerns raised during EMA Good Clinical Practice inspections almost never appear in the medical literature.
restores.univ-rennes.fr/highlights/w...

1/ Disclosure: No conflict of interest 👇

Using reporting guidelines to improve the reproducibility of cooking Christmas tree meringues: the “People tasting trees” cluster-randomised controlled trial - Research Integrity and Peer Review Objectives To test whether improving a Christmas tree meringue recipe using reporting guidelines yields more appealing and sweeter meringues. Design A prospective, superiority, single-blind, cluster-r...

And, 1 year later, the final paper...

link.springer.com/article/10.1...

Public engagement with research reproducibility Public engagement with reproducibility is crucial for fostering trust in science. This Community Page describes how, by using relatable analogies and hands-on activities, participants explored the cha...

Meta-🧵 (🧵 made of 🧵) on our last paper in @plosbiology.org with @constantvinatier.bsky.social, @ingestegeman.bsky.social, @hynekczu.bsky.social, L. Caquelin, @veerlevde.bsky.social & M. Kozula about meta-research. Please repost if you find it meta-enough or just in case you like Xmas spirit.

Ahaha, and full piece is fun :)

The abstract’s is a nice appetizer to taste ;) looking forward to read the piece ! Thanks for this

Of course, I bet you read it but just in case, the text is better than the abstract :)

Thank you, but read it because it is full of jokes :)

Research Misconduct Identified by the FDA This cross-sectional analysis finds that significant departures from good clinical practice in clinical trials identified by the FDA are seldom reflected in the peer-reviewed literature, even when the...

Inspired by and replicating this classic paper by C. Seife at the FDA.

jamanetwork.com/journals/jam...

This study raises the question of responsibility for any corrections that may be necessary in medical literature following the publication of EPARs.

Conclusions
This meta-research survey indicates that health authorities’ GCP inspections are not reflected in the medical literature, even when the inspections have put the data reliability in doubt.

Among the 61 publications, 26 (43%) were related with 24 distinct studies that had an inspection that casted doubts on data reliability, but none mentioned the inspections at or after the time of publication.

Only 1 publication (2%) addressed the inspection findings. Moreover, there were no corrections, retractions or expressions of concern related to inspection findings.

Results
Out of 285 EPARs screened, 57 (20%) mentioned a GCP inspection. Fifty-eight distinct studies with inspections had 61 publications. In most of the cases (n = 47, 77%), the study was published before the EPARs.

Main outcome measures—the main outcome was the mention of the GCP inspection findings in the publication of the inspected studies. We also assessed whether there was any mention of these findings in a correction, retraction or expression of concern.

Data extracted—two reviewers independently gathered information on the GCP inspections and their findings. The reviewers checked related publications for mentions of the inspection and any subsequent correction, retraction, or expressions of concern related to its findings.

Data sources—we screened all EPARs released by the EMA from inception to April 2024 for drugs that were refused or had a withdrawn application.

Design
a retrospective study comparing studies included in European Public Assessment Reports (EPARs) and the corresponding articles published in the medical literature.

Objective
to describe the differences between EMA GCP inspection reports and medical literature on drugs with withdrawn or refused applications.

However, if the findings are not transposed in the medical literature, publication of those trials may convey inaccurate messages.

Health authorities, such as the European Medicines Agency (EMA), inspect clinical sites performing clinical trials and occasionally find evidence of substantial departures from Good Clinical Practice (GCP).

Concordance between European medicine agency good clinical practice inspections and medical literature: a meta-research survey - BMC Medicine Background Health authorities, such as the European Medicines Agency (EMA), inspect clinical sites performing clinical trials and occasionally find evidence of substantial departures from Good Clinica...

New paper published in BMC Medicine led by the super cool Alexandre Terre Becker. This is part of the ResToRes project.

"Concordance between European medicine agency good clinical practice inspections and medical literature: a meta-research survey"

link.springer.com/article/10.1...

Haha, this is brilliant 😂

A short preprint describing our adoption of more consistent and precise use of terminology related to reproducibility, robustness, replicability, repeatability, and credibility.

osf.io/preprints/me...

We might be at a stage where systematic reviews without checks of trustworthiness become a problem in itself - even a danger to patients, as these reviews are considered as highest level of evidence and the foundation of guidelines and clinical practice

Using reporting guidelines to improve the reproducibility of cooking Christmas tree meringues: the “People tasting trees” cluster-randomised controlled trial - Research Integrity and Peer Review Objectives To test whether improving a Christmas tree meringue recipe using reporting guidelines yields more appealing and sweeter meringues. Design A prospective, superiority, single-blind, cluster-r...

New paper just out with @constantvinatier.bsky.social and al. in Research Integrity and Peer Review.

"Using reporting guidelines to improve the reproducibility of cooking Christmas tree meringues: the “People tasting trees” cluster-randomised controlled trial"

link.springer.com/article/10.1...

Efficacy and safety of esketamine for “treatment resistant depression”: registered report for a systematic review with an individual patient data meta-analysis of randomized, double-blind, placebo-con... Background In 2019, the FDA and EMA approved intranasal esketamine for treatment-resistant depression (TRD). The current study re-evaluated its efficacy and safety. Methods This registered report pres...

🚨 Our team has just published a Registered Report in BMC Medicine, one of the very few medical journals that offers this format (if we want better science, we should not follow journal impact factors, we should support journals with the best policies).

Proud to have been a member of @floriannaudet.bsky.social's team. Great to see this out!

As promised, the 🧵 is here :

bsky.app/profile/flor...