ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening.
BACKGROUND:Implementing semi-automated processes to efficiently match patients to clinical trials at the point of care requires both detailed patient data and authoritative information about open studies. OBJECTIVE:To evaluate the utility of the ClinicalTrials.gov registry as a data source for semi-...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2014-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC4205089?pdf=render |
| _version_ | 1818247131655307264 |
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| author | Pascal B Pfiffner JiWon Oh Timothy A Miller Kenneth D Mandl |
| author_facet | Pascal B Pfiffner JiWon Oh Timothy A Miller Kenneth D Mandl |
| author_sort | Pascal B Pfiffner |
| collection | DOAJ |
| description | BACKGROUND:Implementing semi-automated processes to efficiently match patients to clinical trials at the point of care requires both detailed patient data and authoritative information about open studies. OBJECTIVE:To evaluate the utility of the ClinicalTrials.gov registry as a data source for semi-automated trial eligibility screening. METHODS:Eligibility criteria and metadata for 437 trials open for recruitment in four different clinical domains were identified in ClinicalTrials.gov. Trials were evaluated for up to date recruitment status and eligibility criteria were evaluated for obstacles to automated interpretation. Finally, phone or email outreach to coordinators at a subset of the trials was made to assess the accuracy of contact details and recruitment status. RESULTS:24% (104 of 437) of trials declaring on open recruitment status list a study completion date in the past, indicating out of date records. Substantial barriers to automated eligibility interpretation in free form text are present in 81% to up to 94% of all trials. We were unable to contact coordinators at 31% (45 of 146) of the trials in the subset, either by phone or by email. Only 53% (74 of 146) would confirm that they were still recruiting patients. CONCLUSION:Because ClinicalTrials.gov has entries on most US and many international trials, the registry could be repurposed as a comprehensive trial matching data source. Semi-automated point of care recruitment would be facilitated by matching the registry's eligibility criteria against clinical data from electronic health records. But the current entries fall short. Ultimately, improved techniques in natural language processing will facilitate semi-automated complex matching. As immediate next steps, we recommend augmenting ClinicalTrials.gov data entry forms to capture key eligibility criteria in a simple, structured format. |
| first_indexed | 2024-12-12T14:59:50Z |
| format | Article |
| id | doaj.art-9bf72180e24f4fbfb766cdfb9691f46c |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-12T14:59:50Z |
| publishDate | 2014-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-9bf72180e24f4fbfb766cdfb9691f46c2022-12-22T00:20:49ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-01910e11105510.1371/journal.pone.0111055ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening.Pascal B PfiffnerJiWon OhTimothy A MillerKenneth D MandlBACKGROUND:Implementing semi-automated processes to efficiently match patients to clinical trials at the point of care requires both detailed patient data and authoritative information about open studies. OBJECTIVE:To evaluate the utility of the ClinicalTrials.gov registry as a data source for semi-automated trial eligibility screening. METHODS:Eligibility criteria and metadata for 437 trials open for recruitment in four different clinical domains were identified in ClinicalTrials.gov. Trials were evaluated for up to date recruitment status and eligibility criteria were evaluated for obstacles to automated interpretation. Finally, phone or email outreach to coordinators at a subset of the trials was made to assess the accuracy of contact details and recruitment status. RESULTS:24% (104 of 437) of trials declaring on open recruitment status list a study completion date in the past, indicating out of date records. Substantial barriers to automated eligibility interpretation in free form text are present in 81% to up to 94% of all trials. We were unable to contact coordinators at 31% (45 of 146) of the trials in the subset, either by phone or by email. Only 53% (74 of 146) would confirm that they were still recruiting patients. CONCLUSION:Because ClinicalTrials.gov has entries on most US and many international trials, the registry could be repurposed as a comprehensive trial matching data source. Semi-automated point of care recruitment would be facilitated by matching the registry's eligibility criteria against clinical data from electronic health records. But the current entries fall short. Ultimately, improved techniques in natural language processing will facilitate semi-automated complex matching. As immediate next steps, we recommend augmenting ClinicalTrials.gov data entry forms to capture key eligibility criteria in a simple, structured format.http://europepmc.org/articles/PMC4205089?pdf=render |
| spellingShingle | Pascal B Pfiffner JiWon Oh Timothy A Miller Kenneth D Mandl ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening. PLoS ONE |
| title | ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening. |
| title_full | ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening. |
| title_fullStr | ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening. |
| title_full_unstemmed | ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening. |
| title_short | ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening. |
| title_sort | clinicaltrials gov as a data source for semi automated point of care trial eligibility screening |
| url | http://europepmc.org/articles/PMC4205089?pdf=render |
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