Nicholas Kendall , Zach Pennington , Abdelrahman M Hamouda , Mark Cwajna , Sherief Ghozy , David F Kallmes , Benjamin D Elder
{"title":"依从性和影响向ClinicalTrials.gov报告椎管狭窄和脊柱融合相关临床试验的因素","authors":"Nicholas Kendall , Zach Pennington , Abdelrahman M Hamouda , Mark Cwajna , Sherief Ghozy , David F Kallmes , Benjamin D Elder","doi":"10.1016/j.jocn.2025.111148","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> is an online database that was launched in 2000 in order to help increase transparency around clinical trials. The FDA’s Food and Drug Administration Amendments Act of 2007 and the subsequent Final Rule of 2016 attempted to improve compliance for reporting to the site. However, there is still significant noncompliance by researchers. This study evaluated compliance for trials related to spinal stenosis and spinal fusion.</div></div><div><h3>Methods</h3><div>We utilized a previously published algorithm to predict clinical trials that were highly likely to be mandated to report. Trials found under the search criteria “Spinal Fusion OR Spinal Stenosis” and completed before June 2023 were extracted. Data was extracted from <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> on Study Status, Study Results, Interventions, Phases, Funder Type, Study Type, Study Design, Start Date, Primary Completion Date, Results First Posted and Study Locations. Additionally, the number of months between the primary completion date and the reporting of the results in the database were calculated for each study. Due to limited data points, descriptive analysis was conducted.</div></div><div><h3>Results</h3><div>We found 86 studies that were deemed highly likely to be mandated to report. Of these trials, 13 % reported results within 12 months, and 85 % reported within 5 years. Industry (44 %) and other non-federal sources (54 %) were the primary funders, with the NIH funding none of the included studies. Median reporting times were similar across funding sources. Upon analysis, there were no factors that were significantly related to reporting in the 1-year time frame. The only significant factor for 5-year reporting was the year of study completion, with studies completed in 2016 or later showing 100 % compliance.</div></div><div><h3>Conclusion</h3><div>This study highlights improvements in reporting within 5 years since the 2016 Final Rule. However, despite regulatory efforts, there remains an increased need for reporting compliance in spinal fusion and spinal stenosis clinical trials. Continued efforts are needed to ensure increased transparency.</div></div>","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111148"},"PeriodicalIF":1.8000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Compliance and factors affecting reporting of spinal stenosis and spinal-fusion-related clinical trials to ClinicalTrials.gov\",\"authors\":\"Nicholas Kendall , Zach Pennington , Abdelrahman M Hamouda , Mark Cwajna , Sherief Ghozy , David F Kallmes , Benjamin D Elder\",\"doi\":\"10.1016/j.jocn.2025.111148\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> is an online database that was launched in 2000 in order to help increase transparency around clinical trials. The FDA’s Food and Drug Administration Amendments Act of 2007 and the subsequent Final Rule of 2016 attempted to improve compliance for reporting to the site. However, there is still significant noncompliance by researchers. This study evaluated compliance for trials related to spinal stenosis and spinal fusion.</div></div><div><h3>Methods</h3><div>We utilized a previously published algorithm to predict clinical trials that were highly likely to be mandated to report. Trials found under the search criteria “Spinal Fusion OR Spinal Stenosis” and completed before June 2023 were extracted. Data was extracted from <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> on Study Status, Study Results, Interventions, Phases, Funder Type, Study Type, Study Design, Start Date, Primary Completion Date, Results First Posted and Study Locations. Additionally, the number of months between the primary completion date and the reporting of the results in the database were calculated for each study. Due to limited data points, descriptive analysis was conducted.</div></div><div><h3>Results</h3><div>We found 86 studies that were deemed highly likely to be mandated to report. Of these trials, 13 % reported results within 12 months, and 85 % reported within 5 years. Industry (44 %) and other non-federal sources (54 %) were the primary funders, with the NIH funding none of the included studies. Median reporting times were similar across funding sources. Upon analysis, there were no factors that were significantly related to reporting in the 1-year time frame. The only significant factor for 5-year reporting was the year of study completion, with studies completed in 2016 or later showing 100 % compliance.</div></div><div><h3>Conclusion</h3><div>This study highlights improvements in reporting within 5 years since the 2016 Final Rule. However, despite regulatory efforts, there remains an increased need for reporting compliance in spinal fusion and spinal stenosis clinical trials. Continued efforts are needed to ensure increased transparency.</div></div>\",\"PeriodicalId\":15487,\"journal\":{\"name\":\"Journal of Clinical Neuroscience\",\"volume\":\"135 \",\"pages\":\"Article 111148\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Neuroscience\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0967586825001201\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/26 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Neuroscience","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0967586825001201","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/26 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Compliance and factors affecting reporting of spinal stenosis and spinal-fusion-related clinical trials to ClinicalTrials.gov
Introduction
ClinicalTrials.gov is an online database that was launched in 2000 in order to help increase transparency around clinical trials. The FDA’s Food and Drug Administration Amendments Act of 2007 and the subsequent Final Rule of 2016 attempted to improve compliance for reporting to the site. However, there is still significant noncompliance by researchers. This study evaluated compliance for trials related to spinal stenosis and spinal fusion.
Methods
We utilized a previously published algorithm to predict clinical trials that were highly likely to be mandated to report. Trials found under the search criteria “Spinal Fusion OR Spinal Stenosis” and completed before June 2023 were extracted. Data was extracted from ClinicalTrials.gov on Study Status, Study Results, Interventions, Phases, Funder Type, Study Type, Study Design, Start Date, Primary Completion Date, Results First Posted and Study Locations. Additionally, the number of months between the primary completion date and the reporting of the results in the database were calculated for each study. Due to limited data points, descriptive analysis was conducted.
Results
We found 86 studies that were deemed highly likely to be mandated to report. Of these trials, 13 % reported results within 12 months, and 85 % reported within 5 years. Industry (44 %) and other non-federal sources (54 %) were the primary funders, with the NIH funding none of the included studies. Median reporting times were similar across funding sources. Upon analysis, there were no factors that were significantly related to reporting in the 1-year time frame. The only significant factor for 5-year reporting was the year of study completion, with studies completed in 2016 or later showing 100 % compliance.
Conclusion
This study highlights improvements in reporting within 5 years since the 2016 Final Rule. However, despite regulatory efforts, there remains an increased need for reporting compliance in spinal fusion and spinal stenosis clinical trials. Continued efforts are needed to ensure increased transparency.
期刊介绍：
This International journal, Journal of Clinical Neuroscience, publishes articles on clinical neurosurgery and neurology and the related neurosciences such as neuro-pathology, neuro-radiology, neuro-ophthalmology and neuro-physiology.
The journal has a broad International perspective, and emphasises the advances occurring in Asia, the Pacific Rim region, Europe and North America. The Journal acts as a focus for publication of major clinical and laboratory research, as well as publishing solicited manuscripts on specific subjects from experts, case reports and other information of interest to clinicians working in the clinical neurosciences.
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