Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injury
Through many decades of preclinical research, great progress has been achieved in understanding the complex nature of spinal cord injury (SCI). Preclinical research efforts have guided and shaped clinical trials, which are growing in number by the year. Currently, 1,149 clinical trials focused on im...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-09-01
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| Series: | Frontiers in Cellular Neuroscience |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fncel.2022.977679/full |
| _version_ | 1811183429254905856 |
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| author | Valerie A. Dietz Nolan Roberts Katelyn Knox Sherilynne Moore Michael Pitonak Chris Barr Jesus Centeno Scott Leininger Kent C. New Peter Nowell Matthew Rodreick Cedric G. Geoffroy Cedric G. Geoffroy Argyrios Stampas Jennifer N. Dulin Jennifer N. Dulin |
| author_facet | Valerie A. Dietz Nolan Roberts Katelyn Knox Sherilynne Moore Michael Pitonak Chris Barr Jesus Centeno Scott Leininger Kent C. New Peter Nowell Matthew Rodreick Cedric G. Geoffroy Cedric G. Geoffroy Argyrios Stampas Jennifer N. Dulin Jennifer N. Dulin |
| author_sort | Valerie A. Dietz |
| collection | DOAJ |
| description | Through many decades of preclinical research, great progress has been achieved in understanding the complex nature of spinal cord injury (SCI). Preclinical research efforts have guided and shaped clinical trials, which are growing in number by the year. Currently, 1,149 clinical trials focused on improving outcomes after SCI are registered in the U.S. National Library of Medicine at ClinicalTrials.gov. We conducted a systematic analysis of these SCI clinical trials, using publicly accessible data downloaded from ClinicalTrials.gov. After extracting all available data for these trials, we categorized each trial according to the types of interventions being tested and the types of outcomes assessed. We then evaluated clinical trial characteristics, both globally and by year, in order to understand the areas of growth and change over time. With regard to clinical trial attributes, we found that most trials have low enrollment, only test single interventions, and have limited numbers of primary outcomes. Some gaps in reporting are apparent; for instance, over 75% of clinical trials with “Completed” status do not have results posted, and the Phase of some trials is incorrectly classified as “Not applicable” despite testing a drug or biological compound. When analyzing trials based on types of interventions assessed, we identified the largest representation in trials testing rehab/training/exercise, neuromodulation, and behavioral modifications. Most highly represented primary outcomes include motor function of the upper and lower extremities, safety, and pain. The most highly represented secondary outcomes include quality of life and pain. Over the past 15 years, we identified increased representation of neuromodulation and rehabilitation trials, and decreased representation of drug trials. Overall, the number of new clinical trials initiated each year continues to grow, signifying a hopeful future for the clinical treatment of SCI. Together, our work provides a comprehensive glimpse into the past, present, and future of SCI clinical trials, and suggests areas for improvement in clinical trial reporting. |
| first_indexed | 2024-04-11T09:45:54Z |
| format | Article |
| id | doaj.art-f82223113c9346de9d47ed5a8afe916f |
| institution | Directory Open Access Journal |
| issn | 1662-5102 |
| language | English |
| last_indexed | 2024-04-11T09:45:54Z |
| publishDate | 2022-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cellular Neuroscience |
| spelling | doaj.art-f82223113c9346de9d47ed5a8afe916f2022-12-22T04:31:01ZengFrontiers Media S.A.Frontiers in Cellular Neuroscience1662-51022022-09-011610.3389/fncel.2022.977679977679Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injuryValerie A. Dietz0Nolan Roberts1Katelyn Knox2Sherilynne Moore3Michael Pitonak4Chris Barr5Jesus Centeno6Scott Leininger7Kent C. New8Peter Nowell9Matthew Rodreick10Cedric G. Geoffroy11Cedric G. Geoffroy12Argyrios Stampas13Jennifer N. Dulin14Jennifer N. Dulin15Department of Biology, Texas A&M University, College Station, TX, United StatesDepartment of Biology, Texas A&M University, College Station, TX, United StatesDepartment of Biology, Texas A&M University, College Station, TX, United StatesDepartment of Biology, Texas A&M University, College Station, TX, United StatesDepartment of Biology, Texas A&M University, College Station, TX, United StatesUnite 2 Fight Paralysis, Minneapolis, MN, United StatesUnite 2 Fight Paralysis, Minneapolis, MN, United StatesUnite 2 Fight Paralysis, Minneapolis, MN, United StatesUnite 2 Fight Paralysis, Minneapolis, MN, United StatesUnite 2 Fight Paralysis, Minneapolis, MN, United StatesUnite 2 Fight Paralysis, Minneapolis, MN, United StatesDepartment of Neuroscience and Experimental Therapeutics, Texas A&M University, College Station, TX, United StatesTexas A&M Institute for Neuroscience, Texas A&M University, College Station, TX, United StatesDepartment of Physical Medicine and Rehabilitation, UTHealth Houston McGovern Medical School, Houston, TX, United StatesDepartment of Biology, Texas A&M University, College Station, TX, United StatesTexas A&M Institute for Neuroscience, Texas A&M University, College Station, TX, United StatesThrough many decades of preclinical research, great progress has been achieved in understanding the complex nature of spinal cord injury (SCI). Preclinical research efforts have guided and shaped clinical trials, which are growing in number by the year. Currently, 1,149 clinical trials focused on improving outcomes after SCI are registered in the U.S. National Library of Medicine at ClinicalTrials.gov. We conducted a systematic analysis of these SCI clinical trials, using publicly accessible data downloaded from ClinicalTrials.gov. After extracting all available data for these trials, we categorized each trial according to the types of interventions being tested and the types of outcomes assessed. We then evaluated clinical trial characteristics, both globally and by year, in order to understand the areas of growth and change over time. With regard to clinical trial attributes, we found that most trials have low enrollment, only test single interventions, and have limited numbers of primary outcomes. Some gaps in reporting are apparent; for instance, over 75% of clinical trials with “Completed” status do not have results posted, and the Phase of some trials is incorrectly classified as “Not applicable” despite testing a drug or biological compound. When analyzing trials based on types of interventions assessed, we identified the largest representation in trials testing rehab/training/exercise, neuromodulation, and behavioral modifications. Most highly represented primary outcomes include motor function of the upper and lower extremities, safety, and pain. The most highly represented secondary outcomes include quality of life and pain. Over the past 15 years, we identified increased representation of neuromodulation and rehabilitation trials, and decreased representation of drug trials. Overall, the number of new clinical trials initiated each year continues to grow, signifying a hopeful future for the clinical treatment of SCI. Together, our work provides a comprehensive glimpse into the past, present, and future of SCI clinical trials, and suggests areas for improvement in clinical trial reporting.https://www.frontiersin.org/articles/10.3389/fncel.2022.977679/fullclinical trialspinal cord injurysystematic analysistrendsoutcomesinterventions |
| spellingShingle | Valerie A. Dietz Nolan Roberts Katelyn Knox Sherilynne Moore Michael Pitonak Chris Barr Jesus Centeno Scott Leininger Kent C. New Peter Nowell Matthew Rodreick Cedric G. Geoffroy Cedric G. Geoffroy Argyrios Stampas Jennifer N. Dulin Jennifer N. Dulin Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injury Frontiers in Cellular Neuroscience clinical trial spinal cord injury systematic analysis trends outcomes interventions |
| title | Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injury |
| title_full | Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injury |
| title_fullStr | Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injury |
| title_full_unstemmed | Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injury |
| title_short | Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injury |
| title_sort | fighting for recovery on multiple fronts the past present and future of clinical trials for spinal cord injury |
| topic | clinical trial spinal cord injury systematic analysis trends outcomes interventions |
| url | https://www.frontiersin.org/articles/10.3389/fncel.2022.977679/full |
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