Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology
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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/427490", "https://ndownloader.figshare.com/files/427529"], "description"=>"<div><h3>Background</h3><p>There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years.</p><h3>Methodology/Principal Findings</h3><p>We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time.</p><h3>Conclusions/Significance</h3><p>Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.</p></div>", "links"=>[], "tags"=>["changes", "trials", "methodology", "systematic", "decades", "psychopharmacology"], "article_id"=>144381, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.s001", "https://dx.doi.org/10.1371/journal.pone.0009479.s002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Changes_in_Clinical_Trials_Methodology_Over_Time_A_Systematic_Review_of_Six_Decades_of_Research_in_Psychopharmacology/144381", "title"=>"Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2010-03-03 01:13:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/859876"], "description"=>"<p>Flow chart for the selection of Risperidone and Fluoxetine studies.</p>", "links"=>[], "tags"=>["risperidone", "fluoxetine"], "article_id"=>530335, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_chart_for_the_selection_of_Risperidone_and_Fluoxetine_studies_/530335", "title"=>"Flow chart for the selection of Risperidone and Fluoxetine studies.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:05:35"}
  • {"files"=>["https://ndownloader.figshare.com/files/859956"], "description"=>"<p>Flow chart for the selection of Clozapine and Lamotrigine studies.</p>", "links"=>[], "tags"=>["clozapine", "lamotrigine"], "article_id"=>530420, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_chart_for_the_selection_of_Clozapine_and_Lamotrigine_studies_/530420", "title"=>"Flow chart for the selection of Clozapine and Lamotrigine studies.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:07:00"}
  • {"files"=>["https://ndownloader.figshare.com/files/860032"], "description"=>"<p>Flow chart for the selection of Chlorpromazine, Lithium and Diazepam studies.</p>", "links"=>[], "tags"=>["lithium", "diazepam"], "article_id"=>530493, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_chart_for_the_selection_of_Chlorpromazine_Lithium_and_Diazepam_studies_/530493", "title"=>"Flow chart for the selection of Chlorpromazine, Lithium and Diazepam studies.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:08:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/860108"], "description"=>"<p>Blue, red, and green bars show the number of trials adequately reporting background, methods and results in the abstract, respectively, at each period of time. The number of trials per period was 24 (1961 and earlier), 23 (1962–1974), 22 (1975–1989) and 22 (1990 and after).</p>", "links"=>[], "tags"=>["mental health/psychopharmacology", "non-clinical medicine/academic medicine", "non-clinical medicine/history of medicine", "non-clinical medicine/medical education", "non-clinical medicine/medical journals", "non-clinical medicine/research methods"], "article_id"=>530565, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Changes_in_abstract_reporting_over_time_/530565", "title"=>"Changes in abstract reporting over time.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:09:25"}
  • {"files"=>["https://ndownloader.figshare.com/files/860174"], "description"=>"<p>Blue bars represent the number of trials performing two-arm studies; red bars are the trials performing three-arm studies. Green bar represent studies using other designs.The number of trials per period was 24 (1961 and earlier), 23 (1962–1974), 22 (1975–1989) and 22 (1990 and after).</p>", "links"=>[], "tags"=>["mental health/psychopharmacology", "non-clinical medicine/academic medicine", "non-clinical medicine/history of medicine", "non-clinical medicine/medical education", "non-clinical medicine/medical journals", "non-clinical medicine/research methods"], "article_id"=>530629, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g005"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Changes_in_study_design_over_time_/530629", "title"=>"Changes in study design over time.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:10:29"}
  • {"files"=>["https://ndownloader.figshare.com/files/860229"], "description"=>"<p>Blue bars represent the number of trials that had a placebo arm at each period of time. Red bars represent the number of studies using intention-to-treat techniques. Green bars represent the number of studies that clearly reported their eligibility criteria.The number of trials per period was 24 (1961 and earlier), 23 (1962–1974), 22 (1975–1989) and 22 (1990 and after).</p>", "links"=>[], "tags"=>["methodology"], "article_id"=>530692, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g006"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Changes_in_study_methodology_over_time_1_/530692", "title"=>"Changes in study methodology over time (1).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:11:32"}
  • {"files"=>["https://ndownloader.figshare.com/files/860290"], "description"=>"<p>Blue bars represent the number of trials that adequately reported randomization methods at each period of time. Red bars represent the number of studies adequately reporting allocation methods. Green bars represent the studies that adequately stated their primary hypothesis.The number of trials per period was 24 (1961 and earlier), 23 (1962–1974), 22 (1975–1989) and 22 (1990 and after).</p>", "links"=>[], "tags"=>["methodology"], "article_id"=>530752, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g007"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Changes_in_study_methodology_over_time_2_/530752", "title"=>"Changes in study methodology over time (2).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:12:32"}
  • {"files"=>["https://ndownloader.figshare.com/files/860370"], "description"=>"<p>Blue bars represent the number of studies that applied parametric tests in their primary outcome at each time period. Red bars represent the number of studies reporting <i>p</i> values at each time period. Green bars represent the number of studies fully reporting adverse effects at each time period.The number of trials per period was 24 (1961 and earlier), 23 (1962–1974), 22 (1975–1989) and 22 (1990 and after).</p>", "links"=>[], "tags"=>["mental health/psychopharmacology", "non-clinical medicine/academic medicine", "non-clinical medicine/history of medicine", "non-clinical medicine/medical education", "non-clinical medicine/medical journals", "non-clinical medicine/research methods"], "article_id"=>530824, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g008"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Changes_in_results_reporting_over_time_/530824", "title"=>"Changes in results reporting over time.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:13:44"}
  • {"files"=>["https://ndownloader.figshare.com/files/860430"], "description"=>"<p>The figure shows the number of studies in which the conclusion was positive (i.e., confirmed the primary hypothesis) (blue bars), negative (did not confirm the primary hypothesis) (red bars) or unclear, when the authors did not present a clear conclusion/interpretation of their results (green bars).The number of trials per period was 24 (1961 and earlier), 23 (1962–1974), 22 (1975–1989) and 22 (1990 and after).</p>", "links"=>[], "tags"=>["outcomes"], "article_id"=>530890, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g009"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Study_outcomes_over_time_/530890", "title"=>"Study outcomes over time.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:14:50"}
  • {"files"=>["https://ndownloader.figshare.com/files/860484"], "description"=>"<p>The figure shows the number of studies in which the conclusion was consistent, i.e., supported by the results (blue bars); inconsistent (red bars), and dubious (green bars), when it depends on a particular interpretation of the data (for instance, post-hoc analysis, multiple outcomes, etc).The number of trials per period was 24 (1961 and earlier), 23 (1962–1974), 22 (1975–1989) and 22 (1990 and after).</p>", "links"=>[], "tags"=>["conclusions"], "article_id"=>530947, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.g010"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Reliability_of_study_conclusions_over_time_/530947", "title"=>"Reliability of study conclusions over time.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-03-03 00:15:47"}
  • {"files"=>["https://ndownloader.figshare.com/files/860548"], "description"=>"<p>Criteria used for data classification in the present review.</p>", "links"=>[], "tags"=>["classification"], "article_id"=>531004, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Criteria_used_for_data_classification_in_the_present_review_/531004", "title"=>"Criteria used for data classification in the present review.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-03-03 00:16:44"}
  • {"files"=>["https://ndownloader.figshare.com/files/860582"], "description"=>"<p>We used the logistic regression model to analyze the association between each outcome variable (treated as categorical data) and the predictor variable year (treated as continuous data). Also, we used the Chi-square test or the Fisher's exact test for the predictor variables year (when treated as ordinal data, divided in quartiles) and Drug Class, treated as ordinal data, divided in mood stabilizers, antipsychotics and others (fluoxetine and diazepam).</p><p>(*)for number of subjects we used the one-way ANOVA. B (SE) represents B value and its standard deviation.</p>", "links"=>[], "tags"=>["mental health/psychopharmacology", "non-clinical medicine/academic medicine", "non-clinical medicine/history of medicine", "non-clinical medicine/medical education", "non-clinical medicine/medical journals", "non-clinical medicine/research methods"], "article_id"=>531035, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.t003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Data_analysis_and_study_results_/531035", "title"=>"Data analysis and study results.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-03-03 00:17:15"}
  • {"files"=>["https://ndownloader.figshare.com/files/860608"], "description"=>"<p>All data are presented as the number (count) of trials per period, except the number of subjects, which is presented as mean and standard error.</p><p>(*)includes Schizophrenia, “Paraphrenia”, “elderly patients with psychosis” and other types of non-affective psychosis.</p><p>(**)includes Maniac-Depressive Illness, Mania, and Bipolar Disorder.</p>", "links"=>[], "tags"=>["characteristics"], "article_id"=>531068, "categories"=>["Medicine", "Mental Health"], "users"=>["André R. Brunoni", "Laura Tadini", "Felipe Fregni"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0009479.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Shows_the_summary_characteristics_of_the_studies_/531068", "title"=>"Shows the summary characteristics of the studies.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-03-03 00:17:48"}

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  • {"unique-ip"=>"5", "full-text"=>"4", "pdf"=>"1", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"2"}
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  • {"unique-ip"=>"11", "full-text"=>"11", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2014", "month"=>"12"}
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  • {"unique-ip"=>"11", "full-text"=>"9", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2015", "month"=>"12"}
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  • {"unique-ip"=>"10", "full-text"=>"11", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"10"}
  • {"unique-ip"=>"2", "full-text"=>"4", "pdf"=>"0", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"11"}
  • {"unique-ip"=>"4", "full-text"=>"7", "pdf"=>"1", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"12"}
  • {"unique-ip"=>"12", "full-text"=>"12", "pdf"=>"2", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"1"}
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  • {"unique-ip"=>"13", "full-text"=>"16", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"6"}
  • {"unique-ip"=>"16", "full-text"=>"20", "pdf"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"10"}
  • {"unique-ip"=>"7", "full-text"=>"7", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2018", "month"=>"7"}
  • {"unique-ip"=>"10", "full-text"=>"11", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2018", "month"=>"8"}
  • {"unique-ip"=>"15", "full-text"=>"15", "pdf"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"3", "cited-by"=>"0", "year"=>"2018", "month"=>"12"}
  • {"unique-ip"=>"28", "full-text"=>"32", "pdf"=>"3", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2018", "month"=>"11"}
  • {"unique-ip"=>"15", "full-text"=>"17", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"2"}
  • {"unique-ip"=>"9", "full-text"=>"9", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2019", "month"=>"3"}
  • {"unique-ip"=>"18", "full-text"=>"19", "pdf"=>"4", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"4"}
  • {"unique-ip"=>"21", "full-text"=>"14", "pdf"=>"12", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"5"}
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Relative Metric

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