Promoting public access to clinical trial protocols: challenges and recommendations
Abstract Background Recognizing the value of promoting public access to clinical trial protocols, Trials pioneered the way for their publication over a decade ago. However, despite major advances in the public accessibility of information about trial methods and results, protocol sharing remains rel...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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BMC
2018-02-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2510-1 |
| _version_ | 1818290190750318592 |
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| author | An-Wen Chan Asbjørn Hróbjartsson |
| author_facet | An-Wen Chan Asbjørn Hróbjartsson |
| author_sort | An-Wen Chan |
| collection | DOAJ |
| description | Abstract Background Recognizing the value of promoting public access to clinical trial protocols, Trials pioneered the way for their publication over a decade ago. However, despite major advances in the public accessibility of information about trial methods and results, protocol sharing remains relatively rare. Main body Protocol sharing facilitates the critical appraisal of clinical trials and helps to identify and deter the selective reporting of outcomes and analyses. Challenges to the routine availability of high quality trial protocols include the gaps in incentives and adherence mechanisms, limited venues for sharing the original and final protocol versions, and the need for mechanisms to ensure transparent and complete protocol content. Conclusions We propose recommendations for addressing key challenges to protocol sharing in order to promote routine public access to protocols for the benefit of patients and other users of evidence from clinical trials. |
| first_indexed | 2024-12-13T02:24:14Z |
| format | Article |
| id | doaj.art-6ff01f93c5bf4eb7b04b40ce84267aae |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T02:24:14Z |
| publishDate | 2018-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6ff01f93c5bf4eb7b04b40ce84267aae2022-12-22T00:02:42ZengBMCTrials1745-62152018-02-011911710.1186/s13063-018-2510-1Promoting public access to clinical trial protocols: challenges and recommendationsAn-Wen Chan0Asbjørn Hróbjartsson1Women’s College Research Institute, Women’s College HospitalCenter for Evidence-Based Medicine, Odense University HospitalAbstract Background Recognizing the value of promoting public access to clinical trial protocols, Trials pioneered the way for their publication over a decade ago. However, despite major advances in the public accessibility of information about trial methods and results, protocol sharing remains relatively rare. Main body Protocol sharing facilitates the critical appraisal of clinical trials and helps to identify and deter the selective reporting of outcomes and analyses. Challenges to the routine availability of high quality trial protocols include the gaps in incentives and adherence mechanisms, limited venues for sharing the original and final protocol versions, and the need for mechanisms to ensure transparent and complete protocol content. Conclusions We propose recommendations for addressing key challenges to protocol sharing in order to promote routine public access to protocols for the benefit of patients and other users of evidence from clinical trials.http://link.springer.com/article/10.1186/s13063-018-2510-1Clinical trial protocolPublicationTransparencySelective reporting |
| spellingShingle | An-Wen Chan Asbjørn Hróbjartsson Promoting public access to clinical trial protocols: challenges and recommendations Trials Clinical trial protocol Publication Transparency Selective reporting |
| title | Promoting public access to clinical trial protocols: challenges and recommendations |
| title_full | Promoting public access to clinical trial protocols: challenges and recommendations |
| title_fullStr | Promoting public access to clinical trial protocols: challenges and recommendations |
| title_full_unstemmed | Promoting public access to clinical trial protocols: challenges and recommendations |
| title_short | Promoting public access to clinical trial protocols: challenges and recommendations |
| title_sort | promoting public access to clinical trial protocols challenges and recommendations |
| topic | Clinical trial protocol Publication Transparency Selective reporting |
| url | http://link.springer.com/article/10.1186/s13063-018-2510-1 |
| work_keys_str_mv | AT anwenchan promotingpublicaccesstoclinicaltrialprotocolschallengesandrecommendations AT asbjørnhrobjartsson promotingpublicaccesstoclinicaltrialprotocolschallengesandrecommendations |