Inadequate Dissemination of Phase I Trials: A Retrospective Cohort Study
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{"title"=>"Inadequate dissemination of phase i trials: A retrospective cohort study", "type"=>"journal", "authors"=>[{"first_name"=>"Evelyne", "last_name"=>"Decullier", "scopus_author_id"=>"9236601100"}, {"first_name"=>"An Wen", "last_name"=>"Chan", "scopus_author_id"=>"7403168410"}, {"first_name"=>"François", "last_name"=>"Chapuis", "scopus_author_id"=>"7005359854"}], "year"=>2009, "source"=>"PLoS Medicine", "identifiers"=>{"pui"=>"354254064", "doi"=>"10.1371/journal.pmed.1000034", "isbn"=>"1549-1676 (Electronic)", "pmid"=>"19226185", "issn"=>"15491277", "scopus"=>"2-s2.0-61449092661", "sgr"=>"61449092661"}, "id"=>"79d3e10a-0760-30ea-b28c-27b8c40b6f47", "abstract"=>"BACKGROUND: Drug development is ideally a logical sequence in which information from small early studies (Phase I) is subsequently used to inform and plan larger, more definitive studies (Phases II-IV). Phase I trials are unique because they generally provide the first evaluation of new drugs in humans. The conduct and dissemination of Phase I trials have not previously been empirically evaluated. Our objective was to describe the initiation, completion, and publication of Phase I trials in comparison with Phase II-IV trials.\\n\\nMETHODS AND FINDINGS: We reviewed a cohort of all protocols approved by a sample of ethics committees in France from January 1, 1994 to December 31, 1994. The comparison of 140 Phase I trials with 304 Phase II-IV trials, showed that Phase I studies were more likely to be initiated (133/140 [95%] versus 269/304 [88%]), more likely to be completed (127/133 [95%] versus 218/269 [81%]), and more likely to produce confirmatory results (71/83 [86%] versus 125/175 [71%]) than Phase II-IV trials. Publication was less frequent for Phase I studies (21/127 [17%] versus 93/218 [43%]), even if only accounting for studies providing confirmatory results (18/71 [25%] versus 79/125 [63%]).\\n\\nCONCLUSIONS: The initiation, completion, and publications of Phase I trials are different from those of other studies. Moreover, the results of these trials should be published in order to ensure the integrity of the overall body of scientific knowledge, and ultimately the safety of future trial participants and patients.", "link"=>"http://www.mendeley.com/research/inadequate-dissemination-phase-i-trials-retrospective-cohort-study", "reader_count"=>18, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>2, "Librarian"=>1, "Researcher"=>7, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>2, "Other"=>1, "Student > Master"=>1, "Student > Bachelor"=>2}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>2, "Librarian"=>1, "Researcher"=>7, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>2, "Other"=>1, "Student > Master"=>1, "Student > Bachelor"=>2}, "reader_count_by_subject_area"=>{"Biochemistry, Genetics and Molecular Biology"=>2, "Nursing and Health Professions"=>2, "Medicine and Dentistry"=>7, "Agricultural and Biological Sciences"=>2, "Philosophy"=>1, "Chemistry"=>1, "Social Sciences"=>1, "Computer Science"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>7}, "Chemistry"=>{"Chemistry"=>1}, "Social Sciences"=>{"Social Sciences"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>2}, "Computer Science"=>{"Computer Science"=>2}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>2}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>2}, "Philosophy"=>{"Philosophy"=>1}}, "reader_count_by_country"=>{"Canada"=>1, "United States"=>1, "Germany"=>1}, "group_count"=>4}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/448996"], "description"=>"<div><h3>Background</h3><p>Drug development is ideally a logical sequence in which information from small early studies (Phase I) is subsequently used to inform and plan larger, more definitive studies (Phases II–IV). Phase I trials are unique because they generally provide the first evaluation of new drugs in humans. The conduct and dissemination of Phase I trials have not previously been empirically evaluated. Our objective was to describe the initiation, completion, and publication of Phase I trials in comparison with Phase II–IV trials.</p> <h3>Methods and Findings</h3><p>We reviewed a cohort of all protocols approved by a sample of ethics committees in France from January 1, 1994 to December 31, 1994. The comparison of 140 Phase I trials with 304 Phase II–IV trials, showed that Phase I studies were more likely to be initiated (133/140 [95%] versus 269/304 [88%]), more likely to be completed (127/133 [95%] versus 218/269 [81%]), and more likely to produce confirmatory results (71/83 [86%] versus 125/175 [71%]) than Phase II–IV trials. Publication was less frequent for Phase I studies (21/127 [17%] versus 93/218 [43%]), even if only accounting for studies providing confirmatory results (18/71 [25%] versus 79/125 [63%]).</p> <h3>Conclusions</h3><p>The initiation, completion, and publications of Phase I trials are different from those of other studies. Moreover, the results of these trials should be published in order to ensure the integrity of the overall body of scientific knowledge, and ultimately the safety of future trial participants and patients.</p> </div>", "links"=>[], "tags"=>["inadequate", "dissemination", "retrospective", "cohort"], "article_id"=>148489, "categories"=>["Medicine"], "users"=>["Evelyne Decullier", "An-Wen Chan", "François Chapuis"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000034"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Inadequate_Dissemination_of_Phase_I_Trials_A_Retrospective_Cohort_Study/148489", "title"=>"Inadequate Dissemination of Phase I Trials: A Retrospective Cohort Study", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2009-02-17 02:21:29"}
  • {"files"=>["https://ndownloader.figshare.com/files/908078"], "description"=>"<p>Flow Chart of Studies</p>", "links"=>[], "tags"=>["Non-clinical medicine"], "article_id"=>578540, "categories"=>["Medicine"], "users"=>["Evelyne Decullier", "An-Wen Chan", "François Chapuis"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000034.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_Chart_of_Studies_/578540", "title"=>"Flow Chart of Studies", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2009-02-17 02:22:20"}
  • {"files"=>["https://ndownloader.figshare.com/files/908222"], "description"=>"<p>Time from Ethical Approval to Publication for Phase I Versus Phase II–IV Trials</p>", "links"=>[], "tags"=>["Non-clinical medicine"], "article_id"=>578683, "categories"=>["Medicine"], "users"=>["Evelyne Decullier", "An-Wen Chan", "François Chapuis"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000034.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Time_from_Ethical_Approval_to_Publication_for_Phase_I_Versus_Phase_II_8211_IV_Trials_/578683", "title"=>"Time from Ethical Approval to Publication for Phase I Versus Phase II–IV Trials", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2009-02-17 02:24:43"}

PMC Usage Stats | Further Information

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Relative Metric

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