The PROMISE Initiative: Developing Reliable Living Evidence for Pediatric Medication Safety through the Trial Bank Project - Summary - MDSpire

The PROMISE Initiative: Developing Reliable Living Evidence for Pediatric Medication Safety through the Trial Bank Project

  • By

  • Chang Xu

  • Suhail A. Doi

  • Sunita Vohra

  • Luis Furuya-Kanamori

  • Yingxia Wang

  • Lijun Tang

  • Yuan Tian

  • Shiqi Fan

  • Zhen Peng

  • Evan Mayo-Wilson

  • Lifeng Lin

  • Haitao Chu

  • M. Hassan Murad

  • Tianqi Yu

  • Sheyu Li

  • Yaolong Chen

  • Su Golder

  • Yoon Loke

  • Justin Clark

  • Paul Glasziou

  • Liang Du

  • Houwen Lin

  • Zhichun Gu

  • February 21, 2026

  • 0 min

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Objective:

To establish a Trial Bank that aggregates structured trial data to assess medication-related harms in children, addressing a critical gap in pediatric medication safety.

Key Findings:
  • Medication-related harms significantly impact children, with limited existing evidence from RCTs, necessitating improved research focus.
  • AI tools demonstrated high accuracy in literature screening and data extraction for building the Trial Bank, indicating their potential for broader application.
  • Only 14.2% of RCTs focus on children, highlighting a critical gap in pediatric medication safety research that the Trial Bank aims to address.
Interpretation:

The PROMISE initiative aims to fill the evidence gap in pediatric medication safety by leveraging AI to create a continuously updated Trial Bank, which will enhance the synthesis of harm data from RCTs and inform clinical practice.

Limitations:
  • Dependence on the accuracy of AI tools for data extraction and classification, which may introduce errors.
  • Potential biases in trial selection and reporting may affect the comprehensiveness of the Trial Bank, leading to incomplete data on medication-related harms.
Conclusion:

The establishment of the PROMISE Trial Bank represents a significant step towards enhancing pediatric medication safety through reliable, living evidence.

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