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

Frontiers in Cellular Neuroscience, 2022 · DOI: 10.3389/fncel.2022.977679 · Published: September 7, 2022

Spinal Cord Injury Research Methodology & Design

Simple Explanation

This systematic review analyzes 1,149 clinical trials focused on spinal cord injury (SCI) to understand trends in interventions and outcomes over time. The review categorizes trials by interventions (e.g., rehab, drugs, neuromodulation) and outcomes (e.g., motor function, pain, quality of life). The study identifies increased representation of neuromodulation and rehabilitation trials, and decreased representation of drug trials over the past 15 years, highlighting a need for improved clinical trial reporting standards.

Study Duration

Not specified

Participants

1,149 clinical trials

Evidence Level

Systematic Review

Key Findings

1
The number of new SCI clinical trials initiated each year continues to grow, with 50% of all SCI clinical trials initiated between 2016 and 2021.
2
Most trials have low enrollment (73.0% had enrollment of 50 subjects or less) and primarily test single interventions (72.1% listed only one intervention).
3
A significant portion of completed trials (75.4%) do not have results posted on ClinicalTrials.gov, indicating gaps in reporting.

Research Summary

This systematic review examined 1,149 spinal cord injury (SCI) clinical trials from ClinicalTrials.gov to analyze trends in interventions, outcomes, and reporting practices. The analysis revealed an increasing number of new SCI clinical trials, particularly in neuromodulation and rehabilitation, but also highlighted issues such as low enrollment, single interventions, and incomplete results reporting. The study emphasizes the need for improved reporting standards, greater community involvement, and more efficient trial designs to advance SCI treatment and recovery.

Practical Implications

Improved Reporting Standards

ClinicalTrials.gov needs better enforcement of reporting standards to ensure complete and transparent data sharing, enabling informed decisions and reducing trial redundancy.

Community Involvement

Involving individuals with SCI in the research process from start to finish is crucial, including as advisors and peer reviewers, to ensure research aligns with community priorities.

Combination Therapies

Future research should focus on combinatorial clinical trials to combine the most promising therapies, reflecting the complex nature of SCI and the need for multifaceted approaches.

Study Limitations

1
Incomplete data on ClinicalTrials.gov, particularly for trials initiated before 2007
2
Potential for inaccurate classification of trials due to reliance solely on information listed on ClinicalTrials.gov
3
Difficulty in determining whether primary endpoints not met is due to ineffective intervention or other factors

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