Literature DB >> 12775615

Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications.

Hans Melander1, Jane Ahlqvist-Rastad, Gertie Meijer, Björn Beermann.   

Abstract

OBJECTIVES: To investigate the relative impact on publication bias caused by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceutical companies.
DESIGN: 42 placebo controlled studies of five selective serotonin reuptake inhibitors submitted to the Swedish drug regulatory authority as a basis for marketing approval for treating major depression were compared with the studies actually published (between 1983 and 1999).
RESULTS: Multiple publication: 21 studies contributed to at least two publications each, and three studies contributed to five publications. Selective publication: studies showing significant effects of drug were published as stand alone publications more often than studies with non-significant results. Selective reporting: many publications ignored the results of intention to treat analyses and reported the more favourable per protocol analyses only.
CONCLUSIONS: The degree of multiple publication, selective publication, and selective reporting differed between products. Thus, any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.

Entities:  

Keywords:  Biomedical and Behavioral Research; Empirical Approach

Mesh:

Substances:

Year:  2003        PMID: 12775615      PMCID: PMC156459          DOI: 10.1136/bmj.326.7400.1171

Source DB:  PubMed          Journal:  BMJ        ISSN: 0959-8138


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