Extensive selective reporting of quality of life in clinical study reports and publications of placebo-controlled trials of antidepressants

Asger Sand Paludan-Müller, Tarang Sharma, Kristine Rasmussen, Peter C. Gøtzsche*

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstrakt

BACKGROUND: Selective reporting of trial results is common. OBJECTIVE: To study selective reporting in clinical study reports, company trial registers and publications of quality of life in placebo-controlled trials of antidepressants. METHODS: We compared clinical study reports of four antidepressants (fluoxetine, duloxetine, paroxetine and sertraline) obtained from two European drug regulators, data from online company registers, and publications received or retrieved from Eli Lilly and GlaxoSmithKline. Pfizer was also contacted but did not provide any publications. RESULTS: We included 15 trials (19,015 pages) and 4717 patients. Six trials had used SF-36, seven EQ-5D and two both instruments. Nine of the 15 CSRs (60%) displayed selective reporting. In the companies' online registers, there was selective reporting for all 15 trials (100%). We received 20 publications from Eli Lilly and retrieved six from the GlaxoSmithKline register. There was selective reporting in 24 of the 26 publications (92%). Despite extensive selective reporting, we found only small differences between placebo and active drugs. CONCLUSIONS: Access to the full raw data from clinical trials and to case report forms for all patients are needed to evaluate the effect of antidepressants on quality of life. Regulatory agencies should refuse to approve drugs or new indications based on incomplete reporting.

OriginalsprogEngelsk
TidsskriftThe International Journal of Risk and Safety in Medicine
Vol/bind32
Udgave nummer2
Sider (fra-til)87-99
ISSN0924-6479
DOI
StatusUdgivet - 2021
Udgivet eksterntJa

Bibliografisk note

Funding Information:
This study was part of a PhD thesis for TS, funded by the Laura and John Arnold Foundation. The funding source had no role in the design and conduct of the study; data collection, management, analysis, and interpretation; preparation, review, and approval of the manuscript; or the decision to submit the paper for publication.

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