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...
Gespeichert in:
Veröffentlicht in: | Journal of clinical epidemiology 2022-02, Vol.142, p.258-260 |
---|---|
1. Verfasser: | |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
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 |