Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability
Abstract Background Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the pharmaceutical industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent...
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| Format: | Article |
| Language: | English |
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BMC
2018-09-01
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| Series: | BMC Medicine |
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| Online Access: | http://link.springer.com/article/10.1186/s12916-018-1154-z |
| _version_ | 1819262230706782208 |
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| author | Ashley M. Hopkins Andrew Rowland Michael J. Sorich |
| author_facet | Ashley M. Hopkins Andrew Rowland Michael J. Sorich |
| author_sort | Ashley M. Hopkins |
| collection | DOAJ |
| description | Abstract Background Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the pharmaceutical industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the pharmaceutical industry 2 years after publication of the primary results. Main text PubMed and ClinicalTrials.gov were searched to identify clinical trials of medicines sponsored by the pharmaceutical industry and first published between 1 July 2015 and 31 December 2015 in the top 10 general and internal medical journals by impact factor. For each clinical trial, the eligibility of independent researchers to request participant-level data was identified via the sponsor having a data sharing policy/process and a positive response to an enquiry. Fifty-six publications reporting on 61 industry-sponsored clinical trials were identified, of which 32 (52%) had a public data sharing policy/process and 9 (15%) were confirmed eligible for data sharing. Industry sponsors within the top 25 by global sales were more likely to have a data sharing policy (93% vs 10%), and there was a trend towards increased data sharing eligibility (23% vs 4%). Twenty-six studies were explicitly confirmed as ineligible for data sharing. The two most common data sharing policy conditions that prevented sharing of data for published results were the exclusion of studies that had ongoing follow-up of the published results and the exclusion of studies of medicines that have not yet achieved regulatory approval in the USA and the European Union. Conclusions Fifteen percent of the sampled clinical trials were available for data sharing 2 years after publication of primary results of the trial. Key issues limiting data sharing include a large proportion of industry sponsors who do not have a data sharing policy/process, and data sharing policy conditions that exclude access on the basis of ongoing follow-up and regulatory activity. |
| first_indexed | 2024-12-23T19:54:24Z |
| format | Article |
| id | doaj.art-a7f54500ad6f488a88dbf5574edc7e7b |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-12-23T19:54:24Z |
| publishDate | 2018-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj.art-a7f54500ad6f488a88dbf5574edc7e7b2022-12-21T17:33:17ZengBMCBMC Medicine1741-70152018-09-011611610.1186/s12916-018-1154-zData sharing from pharmaceutical industry sponsored clinical studies: audit of data availabilityAshley M. Hopkins0Andrew Rowland1Michael J. Sorich2Flinders Centre for Innovation in Cancer, College of Medicine and Public Health, Flinders UniversityFlinders Centre for Innovation in Cancer, College of Medicine and Public Health, Flinders UniversityFlinders Centre for Innovation in Cancer, College of Medicine and Public Health, Flinders UniversityAbstract Background Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the pharmaceutical industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the pharmaceutical industry 2 years after publication of the primary results. Main text PubMed and ClinicalTrials.gov were searched to identify clinical trials of medicines sponsored by the pharmaceutical industry and first published between 1 July 2015 and 31 December 2015 in the top 10 general and internal medical journals by impact factor. For each clinical trial, the eligibility of independent researchers to request participant-level data was identified via the sponsor having a data sharing policy/process and a positive response to an enquiry. Fifty-six publications reporting on 61 industry-sponsored clinical trials were identified, of which 32 (52%) had a public data sharing policy/process and 9 (15%) were confirmed eligible for data sharing. Industry sponsors within the top 25 by global sales were more likely to have a data sharing policy (93% vs 10%), and there was a trend towards increased data sharing eligibility (23% vs 4%). Twenty-six studies were explicitly confirmed as ineligible for data sharing. The two most common data sharing policy conditions that prevented sharing of data for published results were the exclusion of studies that had ongoing follow-up of the published results and the exclusion of studies of medicines that have not yet achieved regulatory approval in the USA and the European Union. Conclusions Fifteen percent of the sampled clinical trials were available for data sharing 2 years after publication of primary results of the trial. Key issues limiting data sharing include a large proportion of industry sponsors who do not have a data sharing policy/process, and data sharing policy conditions that exclude access on the basis of ongoing follow-up and regulatory activity.http://link.springer.com/article/10.1186/s12916-018-1154-zData sharingClinical trialsPharmaceutical industry |
| spellingShingle | Ashley M. Hopkins Andrew Rowland Michael J. Sorich Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability BMC Medicine Data sharing Clinical trials Pharmaceutical industry |
| title | Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability |
| title_full | Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability |
| title_fullStr | Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability |
| title_full_unstemmed | Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability |
| title_short | Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability |
| title_sort | data sharing from pharmaceutical industry sponsored clinical studies audit of data availability |
| topic | Data sharing Clinical trials Pharmaceutical industry |
| url | http://link.springer.com/article/10.1186/s12916-018-1154-z |
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