Clinical trials were missing from regulatory documents of extended-release methylphenidate for ADHD in adults: a case study of public documents

Kim Boesen*, Karsten Juhl Jørgensen, Peter C. Gøtzsche

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstrakt

Objectives: To assess whether drug regulatory agencies decided on applications for extended-release methylphenidate for use in adult ADHD based on select samples of trials. Study design and setting: Case series of publicly available regulatory documents. We matched an index of extended-release methylphenidate trials for adult ADHD with trials appearing in regulatory documents of extended-release methylphenidate applications. Trials and regulatory documents were identified as part of this systematic review (https://doi.org/10.1002/14651858.CD012857). We sought to identify missing trials in the regulatory documents and to clarify regulatory submission requirements. Results: We indexed 18 trials and matched those with 13 drug applications (11 approved, 2 rejected) published by 7 agencies. There were trials missing in 7 (54%) of 13 applications, median 4 trials (range 1-6). The median proportion of missing trial participants was 45% (range 23% - 72%). Regulators seemingly require that all trials must be included in new drug applications, but wording is ambiguous. Conclusion: In this sample of extended-release methylphenidate drug applications for adult ADHD, 7 of 13 regulatory decisions were missing entire trials according to public documents, even though regulatory requirements seem to stipulate that all available trials should be included in drug applications.

OriginalsprogEngelsk
TidsskriftJournal of Clinical Epidemiology
Vol/bind143
Sider (fra-til)242-253
ISSN0895-4356
DOI
StatusUdgivet - mar. 2022

Bibliografisk note

Funding Information:
METRIC-B (KB) is funded by grants from the Einstein Foundation and Stiftung Charité.

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