Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database
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{"title"=>"Publication bias in antipsychotic trials: An analysis of efficacy comparing the published literature to the us food and drug administration database", "type"=>"journal", "authors"=>[{"first_name"=>"Erick H.", "last_name"=>"Turner", "scopus_author_id"=>"7202447855"}, {"first_name"=>"Daniel", "last_name"=>"Knoepflmacher", "scopus_author_id"=>"55143930200"}, {"first_name"=>"Lee", "last_name"=>"Shapley", "scopus_author_id"=>"55138158200"}], "year"=>2012, "source"=>"PLoS Medicine", "identifiers"=>{"pui"=>"364514777", "issn"=>"15491277", "isbn"=>"1549-1277", "doi"=>"10.1371/journal.pmed.1001189", "scopus"=>"2-s2.0-84858957743", "pmid"=>"22448149", "sgr"=>"84858957743"}, "id"=>"38fa2f7b-1d96-3ccd-8aa4-16e7dc2b124c", "abstract"=>"BACKGROUND: Publication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy.\\n\\nMETHODS AND FINDINGS: FDA Drug Approval Packages for eight second-generation antipsychotics-aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone--were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant.\\n\\nCONCLUSIONS: The magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs.", "link"=>"http://www.mendeley.com/research/publication-bias-antipsychotic-trials-analysis-efficacy-comparing-published-literature-food-drug-adm", "reader_count"=>85, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>6, "Librarian"=>1, "Researcher"=>19, "Student > Doctoral Student"=>11, "Student > Ph. D. 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  • {"files"=>["https://ndownloader.figshare.com/files/664918"], "description"=>"<p>Drug brand name shown in parentheses. A dash indicates that the baseline score is not available in the FDA review. For aripiprazole Trial 94202, the number of sites is based on FDA analysis, which excluded site #003 (see text). For the first three iloperidone trials, parentheses enclose the sample size of the subset of patients with schizophrenia analyzed by the FDA. Dose groups shown only if within FDA-approved dose range. For paliperidone Trials 304 and 305, the FDA review did not list results for the olanzapine group: the corresponding <i>n</i> was taken from the corresponding journal article.</p><p>BPRSd, BPRS score derived from PANSS score; Eur, Europe; Isr, Israel; Mex, Mexico; No Am, North America; Pbo, placebo; So Afr, South Africa; Scz, schizophrenia; Scz-Aff, schizoaffective disorder.</p>", "links"=>[], "tags"=>["premarketing", "trials", "antipsychotics"], "article_id"=>335408, "categories"=>["Science Policy", "Mental Health", "Medicine"], "users"=>["Erick H. Turner", "Daniel Knoepflmacher", "Lee Shapley"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001189.t001", "stats"=>{"downloads"=>0, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Characteristics_of_premarketing_trials_of_antipsychotics_according_to_FDA_/335408", "title"=>"Characteristics of premarketing trials of antipsychotics according to FDA.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-20 01:30:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/340714", "https://ndownloader.figshare.com/files/340807", "https://ndownloader.figshare.com/files/340876", "https://ndownloader.figshare.com/files/340927", "https://ndownloader.figshare.com/files/341004"], "description"=>"<div><h3>Background</h3><p>Publication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy.</p> <h3>Methods and Findings</h3><p>FDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant.</p> <h3>Conclusions</h3><p>The magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs.</p> <h3></h3><p> <em>Please see later in the article for the Editors' Summary</em></p> </div>", "links"=>[], "tags"=>["antipsychotic", "efficacy", "comparing", "published"], "article_id"=>127354, "categories"=>["Science Policy", "Mental Health", "Medicine"], "users"=>["Erick H. Turner", "Daniel Knoepflmacher", "Lee Shapley"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001189.s001", "https://dx.doi.org/10.1371/journal.pmed.1001189.s002", "https://dx.doi.org/10.1371/journal.pmed.1001189.s003", "https://dx.doi.org/10.1371/journal.pmed.1001189.s004", "https://dx.doi.org/10.1371/journal.pmed.1001189.s005"], "stats"=>{"downloads"=>36, "page_views"=>20, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Publication_Bias_in_Antipsychotic_Trials_An_Analysis_of_Efficacy_Comparing_the_Published_Literature_to_the_US_Food_and_Drug_Administration_Database/127354", "title"=>"Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2012-03-20 02:02:34"}
  • {"files"=>["https://ndownloader.figshare.com/files/664984"], "description"=>"<p>Statistically significant <i>p-</i>values (<0.05) are given in bold. Column at far right shows <i>p-</i>values from journal articles; all others are from the FDA review of iloperidone. See text for details.</p>", "links"=>[], "tags"=>["Mental health", "science policy", "Non-clinical medicine"], "article_id"=>335476, "categories"=>["Science Policy", "Mental Health", "Medicine"], "users"=>["Erick H. Turner", "Daniel Knoepflmacher", "Lee Shapley"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001189.t003", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Iloperidone_results_p_values_by_trial_dose_group_and_diagnosis_/335476", "title"=>"Iloperidone results (<i>p-</i>values) by trial, dose group, and diagnosis.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-20 01:31:16"}
  • {"files"=>["https://ndownloader.figshare.com/files/664948"], "description"=>"<p>Bibliographic information on FDA-registered antipsychotic trials.</p>", "links"=>[], "tags"=>["fda-registered", "antipsychotic"], "article_id"=>335440, "categories"=>["Science Policy", "Mental Health", "Medicine"], "users"=>["Erick H. Turner", "Daniel Knoepflmacher", "Lee Shapley"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001189.t002", "stats"=>{"downloads"=>2, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Bibliographic_information_on_FDA_registered_antipsychotic_trials_/335440", "title"=>"Bibliographic information on FDA-registered antipsychotic trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-20 01:30:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/664851"], "description"=>"<p>The figure is sorted according to the effect size point estimates derived from the FDA data; these are shown with gray-filled squares. The point estimates derived from the corresponding journal articles are shown with open circles. Horizontal lines indicate 95% confidence intervals around the effect size point estimates. The right-hand column shows the percent differences between the FDA-based and the journal-based effect size point estimates. (These percent differences are based on estimates accurate to three decimal places, while the estimates shown are rounded to two decimal places.) The differences ranged from −4% to +20%, depending on the drug. For the entire drug class (labeled “overall antipsychotics”), publication bias increased apparent effect size by 8%. To provide context, previously published data on antidepressants <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001189#pmed.1001189-Turner2\" target=\"_blank\">[8]</a> are shown at the bottom in gray. Note that the 8% increase with antipsychotics is much less than the 32% increase with antidepressants <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001189#pmed.1001189-Turner2\" target=\"_blank\">[8]</a>. Also, the journal data show only a 16% advantage in effect size for antipsychotics over antidepressants (from 0.41 to 0.48), while FDA data reveal a much larger advantage (42%, from 0.31 to 0.44).</p>", "links"=>[], "tags"=>["weighted"], "article_id"=>335344, "categories"=>["Science Policy", "Mental Health", "Medicine"], "users"=>["Erick H. Turner", "Daniel Knoepflmacher", "Lee Shapley"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001189.g003", "stats"=>{"downloads"=>3, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Forest_plot_of_mean_weighted_effect_size_Hedges_s_g_values_by_drug_and_data_source_/335344", "title"=>"Forest plot of mean weighted effect size (Hedges's <i>g</i>) values by drug and data source.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-03-20 01:29:04"}
  • {"files"=>["https://ndownloader.figshare.com/files/664768"], "description"=>"<p>The black horizontal bars highlight the four unpublished trials, three of which demonstrated no statistically significant advantage for the drug over placebo. The fourth unpublished trial showed that the drug was superior to placebo but statistically inferior to the active comparator haloperidol. Below the first dotted horizontal line, subtotal effect size and confidence interval values are shown for the subset of published trials and for the subset of unpublished trials. The difference in effect size between the published and unpublished trials was statistically significant (see text). Below the second dotted horizontal line, the FDA-based effect size is shown for all trials combined (0.44). The effect sizes shown for iloperidone trials 3000, 3004, and 3005 are based on the full sample of patients recruited, i.e., those with either schizophrenia or schizoaffective disorder, as opposed to the subset of patients with schizophrenia only (see text for details).</p>", "links"=>[], "tags"=>["fda-registered", "premarketing", "trials", "second-generation"], "article_id"=>335254, "categories"=>["Science Policy", "Mental Health", "Medicine"], "users"=>["Erick H. Turner", "Daniel Knoepflmacher", "Lee Shapley"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001189.g002", "stats"=>{"downloads"=>6, "page_views"=>106, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Forest_plot_of_effect_size_Hedges_s_g_values_for_FDA_registered_premarketing_trials_of_second_generation_antipsychotics_/335254", "title"=>"Forest plot of effect size (Hedges's <i>g</i>) values for FDA-registered premarketing trials of second-generation antipsychotics.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-03-20 01:27:34"}
  • {"files"=>["https://ndownloader.figshare.com/files/664703"], "description"=>"<p>Published trials are shown as white boxes, unpublished trials are shown as black boxes, and the trial numbers are shown within the boxes. Unpublished trials were, with one exception, not positive (either negative or questionable). Please see the text for narrative descriptions of several of these trials. Please note that the number of white boxes does not equal the number of journal articles (see text and <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001189#pmed-1001189-t002\" target=\"_blank\">Table 2</a>): iloperidone trials 3000, 3004, and 3005 were published in a single journal article, and risperidone trial 204 was published as two separate journal articles, as though the US and Canadian sites constituted two distinct positive trials.</p>", "links"=>[], "tags"=>["fda", "24", "premarketing", "trials", "second-generation"], "article_id"=>335187, "categories"=>["Science Policy", "Mental Health", "Medicine"], "users"=>["Erick H. Turner", "Daniel Knoepflmacher", "Lee Shapley"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001189.g001", "stats"=>{"downloads"=>1, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_outcome_according_to_the_FDA_versus_publication_status_of_24_premarketing_trials_of_eight_second_generation_antipsychotics_/335187", "title"=>"Trial outcome according to the FDA versus publication status of 24 premarketing trials of eight second-generation antipsychotics.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-03-20 01:26:27"}

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Relative Metric

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