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Reporting of assignment methods in clinical trials

D H Williams¹, C E Davis

¹Department of Biostatistics, University of North Carolina, Chapel Hill.

Controlled Clinical Trials

|August 1, 1994

Summary

Reporting on clinical trial randomization methods from the 1980s reveals poor descriptions. Most published trial reports lacked sufficient detail, hindering proper assessment of randomization procedures.

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Area of Science:

Clinical Trials Methodology
Biostatistics
Scientific Publication

Background:

The quality of reporting for clinical trial methodologies significantly impacts the reliability and interpretability of research findings.
Accurate documentation of randomization procedures is crucial for assessing the internal validity of clinical trials.

Purpose of the Study:

To evaluate the quality of randomization method descriptions in published clinical trial reports from the 1980s.
To identify variations in reporting quality across different trial strata (small/large, single/multicenter).

Main Methods:

A stratified random sample of 200 clinical trials published in the 1980s was reviewed.
Trial reports were categorized based on trial size, number of centers, and the quality of randomization method description (good, fair, poor, none).

Main Results:

The majority of clinical trial reports from the 1980s provided poor or no description of randomization methods.
While large single-center trials showed a slightly higher proportion of good or fair descriptions, overall reporting quality was inadequate.
Even minimal descriptions often required only a few lines of text, yet were frequently omitted.

Conclusions:

The reporting of randomization methods in clinical trials from the 1980s was generally insufficient.
Poor reporting hinders the ability of readers to ascertain the proper application of randomization, potentially compromising trial validity.

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