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

ABSTRACT:

Importance

Breast milk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims that arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance does not fully address issues specific to BMS trials.

Objectives

To establish new methodological criteria to guide the design, conduct, analysis, and reporting of BMS trials and to support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy, and efficacy of BMS products.

Design, setting, and participants

SUBMITTER: Jarrold K 

PROVIDER: S-EPMC7215627 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature