Clinical trials and tribulations: lessons from spinal cord injury studies registered on ClinicalTrials.gov

Warner, Freda M.; Bailey, Nicole G. N.; Scheuren, Paulina Simonne; Lütolf, Robin; McGregor, Rachel; Banga, Rohan; Hsieh, Jane; Kramer, John L. K.

doi:10.1038/s41393-021-00699-1

Cited by 2 publications

(4 citation statements)

References 22 publications

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“…One of the most noteworthy examples is that although almost half of clinical trials were marked as “Completed,” 75.4% of completed trials have no results available on ClinicalTrials.gov ( Figures 2D,E ). This is similar to a previous finding that only 23.5% of 344 SCI trials with “Completed” status had results posted on ClinicalTrials.gov (Warner et al, 2021 ). However, we found that the absence of posted results did not necessarily mean that results from the study were not available elsewhere.…”

Section: Discussionsupporting

confidence: 91%

“…Our analyses clearly demonstrate that there are gaps in reporting including a lack of clarity with regard to categorizing trials as “interventional,” reporting the specific characteristics of the SCI itself, or reporting of study results. More broadly, multiple studies have identified areas for potential improvement in reporting and usability for ClinicalTrials.gov (Wu et al, 2016 ; Chaturvedi et al, 2019 ; Warner et al, 2021 ). In 2021, Warner et al conducted a systematic analysis on a subset of data extracted from spinal cord injury clinical trials; the authors identified key areas of improvement in reporting of these clinical trials (Warner et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

“…More broadly, multiple studies have identified areas for potential improvement in reporting and usability for ClinicalTrials.gov (Wu et al, 2016 ; Chaturvedi et al, 2019 ; Warner et al, 2021 ). In 2021, Warner et al conducted a systematic analysis on a subset of data extracted from spinal cord injury clinical trials; the authors identified key areas of improvement in reporting of these clinical trials (Warner et al, 2021 ). For instance, only 11.2% of trials correctly identified their study type, provided valid study status and provided sufficient detail about injury characteristics (Warner et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

“…Results of a study may not be posted for the following reasons: the study may not be subject to U.S Federal requirement to submit results, the deadline for results submission has not passed or the submission of results information has been delayed by the submission of a certification or a request to extend the results submission deadline" as per the FDAAA 801 Final Rule (clinicaltrials.gov/ct2/about-site/history). This issue of reporting is not new and has been observed by authors of other metaanalyses based on ClinicalTrials.gov data (Anderson et al, 2015;Warner et al, 2021). It is crucial that the public, scientific and clinical community be able to see results of clinical trials so that informed decisions can be made moving forward and integrated into the decision of participation, funding and approval of future clinical trials.…”

Section: Gaps In Clinical Trial Reportingmentioning

confidence: 99%

See 3 more Smart Citations

Fighting for recovery on multiple fronts: The past, present, and future of clinical trials for spinal cord injury

Dietz

Roberts

Knox

et al. 2022

Front. Cell. Neurosci.

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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.

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Section: Discussionsupporting

confidence: 91%