Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
Publication Date
September 08, 2009
Journal
PLOS Medicine
Authors
Joseph S. Ross, Gregory K. Mulvey, Elizabeth M. Hines, Steven E. Nissen, et al
Volume
6
Issue
9
Pages
e1000144
DOI
https://dx.plos.org/10.1371/journal.pmed.1000144
Publisher URL
http://journals.plos.org/plosmedicine/article?id=10.1371%2Fjournal.pmed.1000144
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/19901971
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2728480
Europe PMC
http://europepmc.org/abstract/MED/19901971
Web of Science
000270818100008
Scopus
70349636711
Mendeley
http://www.mendeley.com/research/trial-publication-after-registration-clinicaltrialsgov-crosssectional-analysis
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Mendeley | Further Information

{"title"=>"Trial publication after registration in ClinicalTrials.gov: A cross-sectional analysis", "type"=>"journal", "authors"=>[{"first_name"=>"Joseph S.", "last_name"=>"Ross", "scopus_author_id"=>"12789607900"}, {"first_name"=>"Gregory K.", "last_name"=>"Mulvey", "scopus_author_id"=>"24471879000"}, {"first_name"=>"Elizabeth M.", "last_name"=>"Hines", "scopus_author_id"=>"57198292867"}, {"first_name"=>"Steven E.", "last_name"=>"Nissen", "scopus_author_id"=>"35264735000"}, {"first_name"=>"Harlan M.", "last_name"=>"Krumholz", "scopus_author_id"=>"7101902574"}], "year"=>2009, "source"=>"PLoS Medicine", "identifiers"=>{"pui"=>"355369595", "sgr"=>"70349636711", "pmid"=>"19901971", "scopus"=>"2-s2.0-70349636711", "isbn"=>"1549-1676", "doi"=>"10.1371/journal.pmed.1000144", "issn"=>"15491277"}, "id"=>"f41b8fc7-b103-3a8d-b3b5-7e227915ee05", "abstract"=>"BACKGROUND: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.\\n\\nMETHODS AND FINDINGS: We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515), nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46%) of trials were published, among which 96 (31%) provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357) were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001), but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22). Among trials that reported an end date, 75 of 123 (61%) completed prior to 2004, 50 of 96 (52%) completed during 2004, and 62 of 149 (42%) completed during 2005 were published (p = 0.006).\\n\\nCONCLUSIONS: Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data elements, the potential for ClinicalTrials.gov to address selective publication of clinical trials will be limited. Please see later in the article for the Editors' Summary.", "link"=>"http://www.mendeley.com/research/trial-publication-after-registration-clinicaltrialsgov-crosssectional-analysis", "reader_count"=>132, "reader_count_by_academic_status"=>{"Unspecified"=>4, "Professor > Associate Professor"=>11, "Librarian"=>6, "Researcher"=>25, "Student > Doctoral Student"=>8, "Student > Ph. D. Student"=>24, "Student > Postgraduate"=>3, "Student > Master"=>21, "Other"=>13, "Student > Bachelor"=>8, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>7}, "reader_count_by_user_role"=>{"Unspecified"=>4, "Professor > Associate Professor"=>11, "Librarian"=>6, "Researcher"=>25, "Student > Doctoral Student"=>8, "Student > Ph. D. Student"=>24, "Student > Postgraduate"=>3, "Student > Master"=>21, "Other"=>13, "Student > Bachelor"=>8, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>7}, "reader_count_by_subject_area"=>{"Unspecified"=>11, "Agricultural and Biological Sciences"=>13, "Business, Management and Accounting"=>2, "Chemistry"=>1, "Computer Science"=>5, "Biochemistry, Genetics and Molecular Biology"=>1, "Nursing and Health Professions"=>1, "Materials Science"=>1, "Mathematics"=>4, "Medicine and Dentistry"=>85, "Neuroscience"=>2, "Pharmacology, Toxicology and Pharmaceutical Science"=>3, "Social Sciences"=>3}, "reader_count_by_subdiscipline"=>{"Materials Science"=>{"Materials Science"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>85}, "Social Sciences"=>{"Social Sciences"=>3}, "Mathematics"=>{"Mathematics"=>4}, "Unspecified"=>{"Unspecified"=>11}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>3}, "Chemistry"=>{"Chemistry"=>1}, "Neuroscience"=>{"Neuroscience"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>13}, "Computer Science"=>{"Computer Science"=>5}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>2}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}}, "reader_count_by_country"=>{"Canada"=>1, "United States"=>12, "China"=>1, "United Kingdom"=>4, "France"=>2, "Australia"=>1, "Germany"=>1}, "group_count"=>11}

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Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/438488"], "description"=>"<div><h3>Background</h3><p>ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.</p><h3>Methods and Findings</h3><p>We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (<em>n = </em>7,515), nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46%) of trials were published, among which 96 (31%) provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357) were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; <em>p</em><0.001), but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; <em>p</em> = 0.22). Among trials that reported an end date, 75 of 123 (61%) completed prior to 2004, 50 of 96 (52%) completed during 2004, and 62 of 149 (42%) completed during 2005 were published (<em>p</em> = 0.006).</p><h3>Conclusions</h3><p>Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data elements, the potential for ClinicalTrials.gov to address selective publication of clinical trials will be limited.</p><h3></h3><p><em>Please see later in the article for the Editors' Summary</em></p></div>", "links"=>[], "tags"=>["registration", "cross-sectional"], "article_id"=>146459, "categories"=>["Medicine", "Information And Computing Sciences"], "users"=>["Joseph S. Ross", "Gregory K. Mulvey", "Elizabeth M. Hines", "Steven E. Nissen", "Harlan M. Krumholz"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000144"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Trial_Publication_after_Registration_in_ClinicalTrials_Gov_A_Cross_Sectional_Analysis/146459", "title"=>"Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2009-09-08 01:47:39"}
  • {"files"=>["https://ndownloader.figshare.com/files/884870"], "description"=>"<p>ClinicalTrials.gov trial inclusion flow chart.</p>", "links"=>[], "tags"=>["inclusion"], "article_id"=>555325, "categories"=>["Medicine", "Information And Computing Sciences"], "users"=>["Joseph S. Ross", "Gregory K. Mulvey", "Elizabeth M. Hines", "Steven E. Nissen", "Harlan M. Krumholz"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000144.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_ClinicalTrials_gov_trial_inclusion_flow_chart_/555325", "title"=>"ClinicalTrials.gov trial inclusion flow chart.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2009-09-08 01:28:45"}
  • {"files"=>["https://ndownloader.figshare.com/files/884945"], "description"=>"*<p><i>p</i>-Value for Pearson Chi-square testing the null hypothesis that publication rates among industry, government, and nonindustry/nongovernment sponsored trials are no different.</p>**<p><i>p</i>-Value for Pearson Chi-square testing the null hypothesis that publication rates among trials that compared an intervention with placebo, trials that compared an intervention with another active agent, trials with no comparison, and observational studies are no different.</p>***<p><i>p</i>-Value for Pearson Chi-square testing the null hypothesis that publication rates among trials with and without end dates provided are no different.</p>a<p>Among interventional trials that reported a trial phase only.</p>b<p>The median trial sample size was 160.</p>c<p>In comparison with trials that did not include older adults.</p>d<p>In comparison with trials that did not include children.</p>", "links"=>[], "tags"=>["rates", "stratified", "characteristics", "subsample", "completed", "trials", "registered"], "article_id"=>555398, "categories"=>["Medicine", "Information And Computing Sciences"], "users"=>["Joseph S. Ross", "Gregory K. Mulvey", "Elizabeth M. Hines", "Steven E. Nissen", "Harlan M. Krumholz"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000144.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Publication_rates_stratified_by_trial_characteristics_among_a_10_random_subsample_of_completed_trials_registered_in_the_ClinicalTrials_gov_database_/555398", "title"=>"Publication rates stratified by trial characteristics among a 10% random subsample of completed trials registered in the ClinicalTrials.gov database.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2009-09-08 01:29:58"}
  • {"files"=>["https://ndownloader.figshare.com/files/884982"], "description"=>"a<p>Proportions may not sum to 100 because of rounding.</p>b<p>Data element is only required to be reported for interventional studies (<i>n</i> = 6,674).</p>", "links"=>[], "tags"=>["completed", "trials", "registered", "december", "1999"], "article_id"=>555434, "categories"=>["Medicine", "Information And Computing Sciences"], "users"=>["Joseph S. Ross", "Gregory K. Mulvey", "Elizabeth M. Hines", "Steven E. Nissen", "Harlan M. Krumholz"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000144.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Characteristics_of_completed_trials_registered_in_the_ClinicalTrials_gov_database_after_December_31_1999_excluding_phase_I_trials_/555434", "title"=>"Characteristics of completed trials registered in the ClinicalTrials.gov database after December 31, 1999 (excluding phase I trials).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2009-09-08 01:30:34"}

PMC Usage Stats | Further Information

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