Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency
To characterize and quantify barriers towards the publication of academic drug trials. We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and pu...
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| creator | Berendt, Louise Petersen, Lene Grejs Bach, Karin Friis Poulsen, Henrik Enghusen Dalhoff, Kim |
| description | To characterize and quantify barriers towards the publication of academic drug trials.
We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004.
A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412).
Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion. |
| doi_str_mv | 10.1371/journal.pone.0172581 |
| format | Article |
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We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004.
A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412).
Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0172581</identifier><identifier>PMID: 28486523</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Analysis ; Classification ; Clinical trials ; Committees ; Corporate sponsorship ; Databases, Factual ; Denmark ; Drug development ; Drug Evaluation ; Drugs ; Engineering and Technology ; Ethics ; Government Agencies ; Growth hormone ; Humans ; Medical personnel ; Medical research ; Medical wastes ; Medicine ; Medicine and Health Sciences ; Pharmaceutical industry ; Pharmacology ; Physical Sciences ; Public health ; Publication bias ; Publishing ; Regulation ; Research and Analysis Methods ; Research funding ; Research institutions ; Software ; Statistical analysis ; Statistics ; Surveys ; Testing</subject><ispartof>PloS one, 2017-05, Vol.12 (5), p.e0172581</ispartof><rights>COPYRIGHT 2017 Public Library of Science</rights><rights>2017 Berendt et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2017 Berendt et al 2017 Berendt et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-22074562cba29d8a3198e09f6df501fa94577104c3125b2593629701f0f259a23</citedby><cites>FETCH-LOGICAL-c692t-22074562cba29d8a3198e09f6df501fa94577104c3125b2593629701f0f259a23</cites><orcidid>0000-0002-4514-6068</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5423601/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5423601/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,725,778,782,862,883,2098,2917,23849,27907,27908,53774,53776,79351,79352</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28486523$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Cox, Dermot</contributor><creatorcontrib>Berendt, Louise</creatorcontrib><creatorcontrib>Petersen, Lene Grejs</creatorcontrib><creatorcontrib>Bach, Karin Friis</creatorcontrib><creatorcontrib>Poulsen, Henrik Enghusen</creatorcontrib><creatorcontrib>Dalhoff, Kim</creatorcontrib><title>Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>To characterize and quantify barriers towards the publication of academic drug trials.
We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004.
A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412).
Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion.</description><subject>Analysis</subject><subject>Classification</subject><subject>Clinical trials</subject><subject>Committees</subject><subject>Corporate sponsorship</subject><subject>Databases, Factual</subject><subject>Denmark</subject><subject>Drug development</subject><subject>Drug Evaluation</subject><subject>Drugs</subject><subject>Engineering and Technology</subject><subject>Ethics</subject><subject>Government Agencies</subject><subject>Growth hormone</subject><subject>Humans</subject><subject>Medical personnel</subject><subject>Medical research</subject><subject>Medical wastes</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Pharmaceutical industry</subject><subject>Pharmacology</subject><subject>Physical Sciences</subject><subject>Public health</subject><subject>Publication bias</subject><subject>Publishing</subject><subject>Regulation</subject><subject>Research and Analysis Methods</subject><subject>Research funding</subject><subject>Research institutions</subject><subject>Software</subject><subject>Statistical analysis</subject><subject>Statistics</subject><subject>Surveys</subject><subject>Testing</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNk02P0zAQhiMEYpfCP0AQCQnBocUfiRNfkMrCQqVFK_F1tSaOk7py42Anu_Tf47TpqkF74GR75pl37BlPFD3HaIFpht9tbO8aMIvWNmqBcEbSHD-IzjGnZM4Iog9P9mfRE-83CKU0Z-xxdEbyJGcpoedR_wGc08r5uLO34MqwrlXc9oXREjptm9hWMUgo1VbLuHR9HXdOg_GL-NIaY2_nfTsgB2MMbevsjSrjYrcX-giN9uv4qyq11I3y8bJWjdw9jR5VAVfPxnUW_bz89OPiy_zq-vPqYnk1l4yTbk4IypKUEVkA4WUOFPNcIV6xskoRroAnaZZhlEiKSVqQlFNGeBY8qAoHIHQWvTzotsZ6MVbMC5xzlicUh3rMotWBKC1sROv0FtxOWNBib7CuFuA6LY0SuUwzDhzRMicJYxIYznGBgRZMcsZw0Ho_ZuuLrSqlajoHZiI69TR6LWp7I9KEUIYGgTejgLO_e-U7sdVeKmOgUbbf35tnoaecBvTVP-j9rxupGsIDdFPZkFcOomKZcEwTmu3TLu6hjk0P36vSwT4JeDsJCEyn_nQ19N6L1fdv_89e_5qyr0_YtQLTrb01_fAP_RRMDqB01nunqrsiYySG6ThWQwzTIcbpCGEvTht0F3QcB_oXO38ILw</recordid><startdate>20170509</startdate><enddate>20170509</enddate><creator>Berendt, Louise</creator><creator>Petersen, Lene Grejs</creator><creator>Bach, Karin Friis</creator><creator>Poulsen, Henrik Enghusen</creator><creator>Dalhoff, Kim</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-4514-6068</orcidid></search><sort><creationdate>20170509</creationdate><title>Barriers towards the publication of academic drug trials. 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Follow-up of trials approved by the Danish Medicines Agency</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2017-05-09</date><risdate>2017</risdate><volume>12</volume><issue>5</issue><spage>e0172581</spage><pages>e0172581-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>To characterize and quantify barriers towards the publication of academic drug trials.
We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004.
A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412).
Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>28486523</pmid><doi>10.1371/journal.pone.0172581</doi><tpages>e0172581</tpages><orcidid>https://orcid.org/0000-0002-4514-6068</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Analysis Classification Clinical trials Committees Corporate sponsorship Databases, Factual Denmark Drug development Drug Evaluation Drugs Engineering and Technology Ethics Government Agencies Growth hormone Humans Medical personnel Medical research Medical wastes Medicine Medicine and Health Sciences Pharmaceutical industry Pharmacology Physical Sciences Public health Publication bias Publishing Regulation Research and Analysis Methods Research funding Research institutions Software Statistical analysis Statistics Surveys Testing |
| title | Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency |
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