Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time
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{"title"=>"Likelihood of null effects of large NHLBI clinical trials has increased over time", "type"=>"journal", "authors"=>[{"first_name"=>"Robert M.", "last_name"=>"Kaplan", "scopus_author_id"=>"7403163131"}, {"first_name"=>"Veronica L.", "last_name"=>"Irvin", "scopus_author_id"=>"6507283434"}], "year"=>2015, "source"=>"PLoS ONE", "identifiers"=>{"doi"=>"10.1371/journal.pone.0132382", "sgr"=>"84941992374", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pmid"=>"26244868", "issn"=>"19326203", "scopus"=>"2-s2.0-84941992374", "pui"=>"606056927"}, "id"=>"04f4c083-f135-3873-b409-4eb96c9ffb2a", "abstract"=>"BACKGROUND: We explore whether the number of null results in large National Heart Lung, and Blood Institute (NHLBI) funded trials has increased over time.\\n\\nMETHODS: We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality.\\n\\nRESULTS: 17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ2=12.2,df= 1, p=0.0005). There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings.\\n\\nCONCLUSIONS: The number NHLBI trials reporting positive results declined after the year 2000. Prospective declaration of outcomes in RCTs, and the adoption of transparent reporting standards, as required by clinicaltrials.gov, may have contributed to the trend toward null findings.", "link"=>"http://www.mendeley.com/research/likelihood-null-effects-large-nhlbi-clinical-trials-increased-time", "reader_count"=>136, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>10, "Librarian"=>2, "Student > Doctoral Student"=>5, "Researcher"=>32, "Student > Ph. D. Student"=>30, "Student > Postgraduate"=>1, "Student > Master"=>13, "Other"=>14, "Student > Bachelor"=>8, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>2, "Professor"=>15}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>10, "Librarian"=>2, "Student > Doctoral Student"=>5, "Researcher"=>32, "Student > Ph. D. Student"=>30, "Student > Postgraduate"=>1, "Student > Master"=>13, "Other"=>14, "Student > Bachelor"=>8, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>2, "Professor"=>15}, "reader_count_by_subject_area"=>{"Unspecified"=>12, "Agricultural and Biological Sciences"=>16, "Computer Science"=>9, "Decision Sciences"=>1, "Economics, Econometrics and Finance"=>2, "Environmental Science"=>1, "Biochemistry, Genetics and Molecular Biology"=>2, "Nursing and Health Professions"=>1, "Materials Science"=>1, "Mathematics"=>5, "Medicine and Dentistry"=>38, "Neuroscience"=>2, "Sports and Recreations"=>1, "Psychology"=>36, "Social Sciences"=>8, "Linguistics"=>1}, "reader_count_by_subdiscipline"=>{"Materials Science"=>{"Materials Science"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>38}, "Social Sciences"=>{"Social Sciences"=>8}, "Decision Sciences"=>{"Decision Sciences"=>1}, "Sports and Recreations"=>{"Sports and Recreations"=>1}, "Psychology"=>{"Psychology"=>36}, "Mathematics"=>{"Mathematics"=>5}, "Unspecified"=>{"Unspecified"=>12}, "Environmental Science"=>{"Environmental Science"=>1}, "Neuroscience"=>{"Neuroscience"=>2}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>16}, "Computer Science"=>{"Computer Science"=>9}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Linguistics"=>{"Linguistics"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>2}}, "reader_count_by_country"=>{"United States"=>5, "United Kingdom"=>3, "Switzerland"=>1, "New Zealand"=>1, "Canada"=>2, "Netherlands"=>1, "Sweden"=>1, "Norway"=>1, "Luxembourg"=>1, "Serbia and Montenegro"=>1, "France"=>2, "Chile"=>1, "Germany"=>2}, "group_count"=>7}

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  • {"files"=>["https://ndownloader.figshare.com/files/2202756", "https://ndownloader.figshare.com/files/2202757", "https://ndownloader.figshare.com/files/2202758", "https://ndownloader.figshare.com/files/2202760", "https://ndownloader.figshare.com/files/2202761", "https://ndownloader.figshare.com/files/2202762", "https://ndownloader.figshare.com/files/2202763", "https://ndownloader.figshare.com/files/2202764", "https://ndownloader.figshare.com/files/2202765", "https://ndownloader.figshare.com/files/2202766", "https://ndownloader.figshare.com/files/2202767"], "description"=>"<div><p>Background</p><p>We explore whether the number of null results in large National Heart Lung, and Blood Institute (NHLBI) funded trials has increased over time.</p><p>Methods</p><p>We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality.</p><p>Results</p><p>17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ<sup>2</sup>=12.2,df= 1, p=0.0005). There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings.</p><p>Conclusions</p><p>The number NHLBI trials reporting positive results declined after the year 2000. Prospective declaration of outcomes in RCTs, and the adoption of transparent reporting standards, as required by clinicaltrials.gov, may have contributed to the trend toward null findings.</p></div>", "links"=>[], "tags"=>["Large NHLBI Clinical Trials", "placebo comparator", "National Heart Lung", "Null Effects", "mortality.Results 17", "year 2000.", "Blood Institute", "adult humans", "outcome", "rct", "findings.ConclusionsThe number NHLBI trials", "Time BackgroundWe", "55 trials meeting"], "article_id"=>1503776, "categories"=>["Biological Sciences"], "users"=>["Robert M. Kaplan", "Veronica L. Irvin"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0132382.s001", "https://dx.doi.org/10.1371/journal.pone.0132382.s002", "https://dx.doi.org/10.1371/journal.pone.0132382.s003", "https://dx.doi.org/10.1371/journal.pone.0132382.s004", "https://dx.doi.org/10.1371/journal.pone.0132382.s005", "https://dx.doi.org/10.1371/journal.pone.0132382.s006", "https://dx.doi.org/10.1371/journal.pone.0132382.s007", "https://dx.doi.org/10.1371/journal.pone.0132382.s008", "https://dx.doi.org/10.1371/journal.pone.0132382.s009", "https://dx.doi.org/10.1371/journal.pone.0132382.s010", "https://dx.doi.org/10.1371/journal.pone.0132382.s011"], "stats"=>{"downloads"=>30, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Likelihood_of_Null_Effects_of_Large_NHLBI_Clinical_Trials_Has_Increased_over_Time_/1503776", "title"=>"Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2015-08-05 04:22:09"}
  • {"files"=>["https://ndownloader.figshare.com/files/2202705"], "description"=>"<p>Positive trials are indicated by the plus signs while trials showing harm are indicated by a diagonal line within a circle. Prior to 2000 when trials were not registered in clinical trials.gov, there was substantial variability in outcome. Following the imposition of the requirement that trials preregister in clinical trials.gov the relative risk on primary outcomes showed considerably less variability around 1.0.</p>", "links"=>[], "tags"=>["Large NHLBI Clinical Trials", "placebo comparator", "National Heart Lung", "Null Effects", "mortality.Results 17", "year 2000.", "Blood Institute", "adult humans", "outcome", "rct", "findings.ConclusionsThe number NHLBI trials", "Time BackgroundWe", "55 trials meeting"], "article_id"=>1503752, "categories"=>["Biological Sciences"], "users"=>["Robert M. Kaplan", "Veronica L. Irvin"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0132382.g001", "stats"=>{"downloads"=>7, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Relative_risk_of_showing_benefit_or_harm_of_treatment_by_year_of_publication_for_large_NHLBI_trials_on_pharmaceutical_and_dietary_supplement_interventions_/1503752", "title"=>"Relative risk of showing benefit or harm of treatment by year of publication for large NHLBI trials on pharmaceutical and dietary supplement interventions.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-08-05 04:22:09"}
  • {"files"=>["https://ndownloader.figshare.com/files/2202707"], "description"=>"<p>Trials indicated by shading and black boxes had statistically significant effects of intervention while trials not shaded and represented by gray boxes had null effects.</p>", "links"=>[], "tags"=>["Large NHLBI Clinical Trials", "placebo comparator", "National Heart Lung", "Null Effects", "mortality.Results 17", "year 2000.", "Blood Institute", "adult humans", "outcome", "rct", "findings.ConclusionsThe number NHLBI trials", "Time BackgroundWe", "55 trials meeting"], "article_id"=>1503754, "categories"=>["Biological Sciences"], "users"=>["Robert M. Kaplan", "Veronica L. Irvin"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0132382.g002", "stats"=>{"downloads"=>3, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_of_results_on_the_primary_outcome_in_NHLBI_trials_on_pharmaceutical_and_supplement_interventions_that_were_not_pre_registered_in_clinical_trials_gov_panel_A_and_pre_registered_in_clinical_trials_gov_panel_B_/1503754", "title"=>"Summary of results on the primary outcome in NHLBI trials on pharmaceutical and supplement interventions that were not pre-registered in clinical trials.gov (panel A) and pre-registered in clinical trials.gov (panel B).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-08-05 04:22:09"}
  • {"files"=>["https://ndownloader.figshare.com/files/2202708"], "description"=>"<p>Study characteristics and overall effect for main outcome and total mortality for studies not registered in ClinicalTrials.gov prior to publication.</p>", "links"=>[], "tags"=>["Large NHLBI Clinical Trials", "placebo comparator", "National Heart Lung", "Null Effects", "mortality.Results 17", "year 2000.", "Blood Institute", "adult humans", "outcome", "rct", "findings.ConclusionsThe number NHLBI trials", "Time BackgroundWe", "55 trials meeting"], "article_id"=>1503755, "categories"=>["Biological Sciences"], "users"=>["Robert M. Kaplan", "Veronica L. Irvin"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0132382.t001", "stats"=>{"downloads"=>6, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Study_characteristics_and_overall_effect_for_main_outcome_and_total_mortality_for_studies_not_registered_in_ClinicalTrials_gov_prior_to_publication_/1503755", "title"=>"Study characteristics and overall effect for main outcome and total mortality for studies not registered in ClinicalTrials.gov prior to publication.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-08-05 04:22:09"}
  • {"files"=>["https://ndownloader.figshare.com/files/2202709"], "description"=>"<p>Study characteristics and overall effect for main outcome and total mortality for studies registered in ClinicalTrials.gov prior to publication.</p>", "links"=>[], "tags"=>["Large NHLBI Clinical Trials", "placebo comparator", "National Heart Lung", "Null Effects", "mortality.Results 17", "year 2000.", "Blood Institute", "adult humans", "outcome", "rct", "findings.ConclusionsThe number NHLBI trials", "Time BackgroundWe", "55 trials meeting"], "article_id"=>1503756, "categories"=>["Biological Sciences"], "users"=>["Robert M. Kaplan", "Veronica L. Irvin"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0132382.t002", "stats"=>{"downloads"=>8, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Study_characteristics_and_overall_effect_for_main_outcome_and_total_mortality_for_studies_registered_in_ClinicalTrials_gov_prior_to_publication_/1503756", "title"=>"Study characteristics and overall effect for main outcome and total mortality for studies registered in ClinicalTrials.gov prior to publication.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-08-05 04:22:09"}
  • {"files"=>["https://ndownloader.figshare.com/files/2202710"], "description"=>"<p><sup>a.</sup> The CDP trial did not show mortality benefits with the original follow-up period. If we had analyzed the subsequent follow-up trial that was not apriori, treatment with niacin would have shown a significant benefit to total mortality.</p><p><sup>b.</sup> The PREVENT study was stopped early for effectiveness seen in the primary outcome. The number of deaths reported shows a null effect on total mortality; but this study might have shown a benefit for total mortality had the full follow-up been completed. We report it here as significant but it will show as null in the meta-analyses.</p><p><sup>c.</sup> The SANDS study did not show any differences on total mortality or reduction of cardiovascular disease events. However, the treatment arm experienced significantly more adverse events. SANDS study authors concluded that there may not be favorable long-term outcomes for participants randomized to treatment.</p><p><sup>d.</sup> Chi-square test uses the Yates correction for continuity.</p><p>Summary of Published Drug and Supplement NHLBI Trials, 1970–2012.</p>", "links"=>[], "tags"=>["Large NHLBI Clinical Trials", "placebo comparator", "National Heart Lung", "Null Effects", "mortality.Results 17", "year 2000.", "Blood Institute", "adult humans", "outcome", "rct", "findings.ConclusionsThe number NHLBI trials", "Time BackgroundWe", "55 trials meeting"], "article_id"=>1503757, "categories"=>["Biological Sciences"], "users"=>["Robert M. Kaplan", "Veronica L. Irvin"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0132382.t003", "stats"=>{"downloads"=>11, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_of_Published_Drug_and_Supplement_NHLBI_Trials_1970_8211_2012_/1503757", "title"=>"Summary of Published Drug and Supplement NHLBI Trials, 1970–2012.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-08-05 04:22:09"}

PMC Usage Stats | Further Information

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Relative Metric

{"start_date"=>"2015-01-01T00:00:00Z", "end_date"=>"2015-12-31T00:00:00Z", "subject_areas"=>[]}
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