Guidance for the Conduct and Reporting of Clinical Trials of Breast Milk Substitutes

Jarrold K et al. JAMA Pediatr. 2020 May 11. doi: 10.1001/jamapediatrics.2020.0578. Online ahead of print.

Key Points

Question What is the best way to ensure the validity of clinical trials of breast milk substitutes while protecting trial participants?

Findings Through a Delphi consensus project, guidance was developed to address issues specific to trials of breast milk substitutes assessing growth and tolerance, as well as trials of breast milk substitutes with other objectives. This consensus guidance summarizes best practice for the design, conduct, analysis, and reporting of trials of breast milk substitutes.

Meaning Use of this guidance, in conjunction with existing clinical trial regulations, should enhance the quality and validity of trials of breast milk substitutes, protect trial participants, and support the evidence base for infant nutrition recommendations.

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