Predicting Methodological Quality in No Profit Clinical Trial

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Analysis predicts methodological quality from clinical trial features, suggesting biostatistics involvement improves adherence.

Higher methodological quality is linked to the presence of a biostatistics unit in clinical trials, which significantly improves adherence.
The analysis revealed a median adherence to SPIRIT guidelines of 72% across all protocols, highlighting areas for improvement.
Machine learning models showed good discriminative ability with an AUC of 0.792, identifying critical predictors of adherence.
Protocols pertaining to pediatric populations demonstrated lower adherence rates, indicating a need for focused guidance and support.

Gambini et al. (2025) studied this question.

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