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The following is a summary of “Evaluating multiplicity reporting in analgesic clinical trials: An analytical review,” published in the November 2024 issue of Pain by Khan et al.
Multiplicity correction in analgesic randomized controlled trials (RCTs) remained unclear despite advancements in statistical methods and regulatory guidelines due to the risk of inflating false positive rates from multiple comparisons.
Researchers conducted a retrospective study to identify reporting inadequacies in multiple analysis adjustments and explanations to understand the deficiencies.
They analyzed RCTs from the European Journal of Pain, Journal of Pain, and PAIN published between January 2018 and December 2022. The included trials were randomized, double-blind, and focused on pain outcomes, 3 researchers extracted data based on predefined criteria, covering trial characteristics, the presence of multiplicity, and correction methods. Descriptive statistics were applied, including Fisher’s exact test and Holm’s method for multiple comparisons.
The results showed that out of 112 articles, 48 specified a primary analysis plan. Multiple analyses were reported in 65 articles, with 60% adjusting for all comparisons, mainly using the Bonferroni method. When stratified by trial type, size, and sponsor, no substantial changes in multiplicity correction practices were observed.
Investigators concluded the analgesic clinical trials continue to rely heavily on multiple comparisons without adequate multiplicity corrections.
Source: onlinelibrary.wiley.com/doi/abs/10.1002/ejp.4756
