A Quantitative Analysis of Clinical Trial Designs in Spinal Cord Injury Based on ICCP Guidelines

JOURNAL OF NEUROTRAUMA, 2012 · DOI: 10.1089/neu.2011.2162 · Published: June 10, 2012

Spinal Cord Injury Neurorehabilitation Research Methodology & Design

Simple Explanation

This study analyzes spinal cord injury (SCI) clinical trials to see if they follow guidelines from the International Campaign for Cures of SCI Paralysis (ICCP). The study looks at trial designs, participant characteristics, and how these trials reflect the broader SCI patient population. Data from ClinicalTrials.gov and the National SCI Statistical Center were used to assess trends and consistency with ICCP recommendations.

Study Duration

Not specified

Participants

288 SCI trials in ClinicalTrials.gov

Evidence Level

Not specified

Key Findings

1
Most interventional studies were randomized and controlled, aligning with ICCP recommendations, and blinding practices have increased over time.
2
Age inclusion criteria in trials often skew older compared to the overall SCI population, while ASIA status criteria generally reflect the population.
3
There's a need for more consistent and standardized reporting of inclusion criteria and outcomes to enable better comparisons across trials.

Research Summary

The study quantitatively assessed SCI clinical trials against ICCP best practice guidelines and representation of the SCI population. It found increasing trends in randomization, blinding, and use of controls in interventional studies, alongside a focus on drug trials and behavioral interventions. The analysis highlights the need for improved reporting standards and consideration of age inclusion criteria to better reflect the SCI patient demographic.

Practical Implications

Improved Trial Design

Encourage adherence to ICCP guidelines for randomization, blinding, and control groups to enhance the reliability of trial results.

Refined Inclusion Criteria

Re-evaluate age inclusion criteria to ensure representation of the SCI population, potentially including younger patients and adjusting upper age limits.

Standardized Reporting

Promote consistent and detailed reporting of inclusion criteria and outcomes to facilitate comparisons across different trials and interventions.

Study Limitations

1
Heterogeneity of conditions, interventions, and outcomes in the analyzed trials.
2
Limited coverage and comparability of data in the ClinicalTrials.gov database.
3
The NSCIDB may not be fully representative of all SCI patients due to its focus on large, urban medical centers.

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