Missing trials in drug regulatory dossiers may have good reasons, but should be predefined and transparent

Boesen and colleagues have done a tremendous job in addressing the question: when I have a list of clinical trials of a class of long-acting medicinal products containing methylphenidate, and I want to see whether these trials also pop-up in the regulatory dossiers that are assumed to deal with the...

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Veröffentlicht in:Journal of clinical epidemiology 2022-02, Vol.142, p.258-260
1. Verfasser: Leufkens, Hubert G.
Format: Artikel
Sprache:eng
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Zusammenfassung:Boesen and colleagues have done a tremendous job in addressing the question: when I have a list of clinical trials of a class of long-acting medicinal products containing methylphenidate, and I want to see whether these trials also pop-up in the regulatory dossiers that are assumed to deal with the licensing process of these products for use in adult patients with ADHD, what do I see? [1]. [...]the case selection for the study of long-acting methylphenidate indicated for adult patients with ADHD. The authors conclude that in 7/13 applications for long-acting medicinal products containing methylphenidate clinical trials they tagged from a systematic review, have not been reported or could be flagged otherwise as missing. [...]that's one of the aims and ambitions of regulatory science, i.e. keeping up the agencies with the most recent science [9,10].
ISSN:0895-4356
1878-5921
DOI:10.1016/j.jclinepi.2021.10.026