Abstract
Study design
Article.
Objective
ClinicalTrials.gov is an online trial registry that provides public access to information on past, present, and future clinical trials. While increasing transparency in research, the quality of the information provided in trial registrations is highly variable. The objective of this study is to assess key areas of information on ClinicalTrials.gov in interventional trials involving people with spinal cord injuries.
Setting
Interventional trials on ClinicalTrials.gov involving people with spinal cord injuries.
Methods
A subset of data on interventional spinal cord injury trials was downloaded from ClinicalTrials.gov. Reviewers extracted information pertaining to study type, injury etiology, spinal cord injury characteristics, timing, study status, and results.
Results
Of the interventional trial registrations reviewed, 62.5%, 58.6%, and 24.3% reported injury level, severity, and etiology, respectively. The timing of intervention relative to injury was reported in 72.8% of registrations. Most trials identified a valid study status (89.2%), but only 23.5% of those completed studies had posted results.
Conclusions
Our review provides a snapshot of interventional clinical trials conducted in the field of spinal cord injury and registered in ClinicalTrials.gov. Areas for improvement were identified with regards to reporting injury characteristics, as well as posting results.
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Data availability
Data can be readily accessed and downloaded from ClinicalTrials.gov using the search and inclusion-exclusion criteria described in the “Methods”.
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Authors and Affiliations
Contributions
FMW contributed to designing the review protocol, interpreting the results, and writing the report. NB conducted the search and screening of studies, contributed to data extraction and cleaning, and provided feedback on the report. PSS contributed to interpreting the results and providing feedback on the report. RL contributed to interpreting the results and providing feedback on the report. RM contributed to data extraction and cleaning, and provided feedback on the report. RB contributed to data extraction and cleaning, and provided feedback on the report. JTCH contributed to designing the review protocol and writing the report. JLKK contributed to designing the review protocol, interpreting the results, and writing the report.
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Authors JTCH, PSS, and RL wish to declare a non-financial conflict of interest due to their involvement in the development of SCITrialsFinder.net.
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This study did not concern animal experimentation or the use of human volunteers.
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Warner, F.M., Bailey, N.G., Scheuren, P.S. et al. Clinical trials and tribulations: lessons from spinal cord injury studies registered on ClinicalTrials.gov. Spinal Cord 59, 1256–1260 (2021). https://doi.org/10.1038/s41393-021-00699-1
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DOI: https://doi.org/10.1038/s41393-021-00699-1
