Response to “Trial design, conflict of interest, and evidence independence in the JASMINE trial and its economic evaluations”

The JASMINE study was designed as a multicenter, randomized Phase III registration trial (jRCT2031210384) conducted under the Japanese Good Clinical Practice (GCP) framework to evaluate the safety and efficacy of an exclusive human milk diet (EHMD) in Japanese very low birth weight (VLBW) infants. Because the intervention consisted of different nutritional products requiring distinct preparation and administration procedures, blinding of treating clinicians was not practically feasible. Several design elements were implemented to minimize potential observer bias. Randomization was performed centrally using a permuted-block scheme stratified by study site and birth weight, with allocation concealment maintained until assignment. Clinical management followed predefined protocols across participating NICUs, and major outcomes, including body weight, time to full enteral feeding, and adverse events, were prospectively defined. Although blinded endpoint adjudication was not incorporated into the study design, randomization, protocol standardization, prospective data collection, and GCP-compliant monitoring, including on-site source data verification, were implemented to safeguard data integrity. We nevertheless recognize that the open-label design and absence of blinded endpoint adjudication are limitations of the trial and should be considered when interpreting outcomes that may be influenced by clinical management decisions.