Article type
Year
Abstract
Background: Breastmilk substitutes (BMS, also known as infant formula), are widely consumed by infants at an early stage of development and in very high volumes. Clinical trials of BMS products evaluate their safety and influence on health and are essential for making decisions about infant nutrition. BMS trials form a core part of a global industry, but seem to be sensitive to commercial pressures, have a light level of regulation, and are thought to have issues with specific forms of bias. Meta-research investigates research practices to understand how to reduce biases in science and thereby deliver more reliable conclusions from scientific studies.
Objectives: A meta-research evaluation of recently published BMS trials to establish whether trial data were correctly and completely analysed, reported and interpreted and to describe whether financial conflicts of interest of study authors influenced study results.
Methods: Peer-reviewed publications of clinical trials with at least one BMS head-to-head comparison published in the last 10 years will be included. A stepwise data-reduction strategy will identify the main trial publication and the main trial outcome for each trial. Analysis will include evaluation of biases (RoB 2 tool), risk of undermining breastfeeding within the trial, registration and reporting practices, ethical standards, conflicts of interest, spin as well as ethical and marketing standards.
Results: Recently, several groups of academics and regulators identified flaws in published BMS trials. Specific issues included biases related to attrition and selective outcome reporting, a lack of independent trial oversight and unclear and variable regulatory requirements compared with drug trials. In some trials, study procedures appeared to directly contravene the International Code of Marketing of Breast-milk Substitutes, for example by providing free BMS products to trial participants. This meta-research evaluation will provide detailed evidence and evaluation of these issues.
Conclusions: This meta-research evaluation will generate knowledge on how to better design, conduct, report and regulate BMS trials, leading to better decisions regarding infant nutrition.
Patient or healthcare consumer involvement: We consulted former BMS research participants, who were surprised at the possibility that trial results may be subject to bias or commercial interests and offered insightful solutions on how to disincentivise switching to formula feeding within BMS trials.
Objectives: A meta-research evaluation of recently published BMS trials to establish whether trial data were correctly and completely analysed, reported and interpreted and to describe whether financial conflicts of interest of study authors influenced study results.
Methods: Peer-reviewed publications of clinical trials with at least one BMS head-to-head comparison published in the last 10 years will be included. A stepwise data-reduction strategy will identify the main trial publication and the main trial outcome for each trial. Analysis will include evaluation of biases (RoB 2 tool), risk of undermining breastfeeding within the trial, registration and reporting practices, ethical standards, conflicts of interest, spin as well as ethical and marketing standards.
Results: Recently, several groups of academics and regulators identified flaws in published BMS trials. Specific issues included biases related to attrition and selective outcome reporting, a lack of independent trial oversight and unclear and variable regulatory requirements compared with drug trials. In some trials, study procedures appeared to directly contravene the International Code of Marketing of Breast-milk Substitutes, for example by providing free BMS products to trial participants. This meta-research evaluation will provide detailed evidence and evaluation of these issues.
Conclusions: This meta-research evaluation will generate knowledge on how to better design, conduct, report and regulate BMS trials, leading to better decisions regarding infant nutrition.
Patient or healthcare consumer involvement: We consulted former BMS research participants, who were surprised at the possibility that trial results may be subject to bias or commercial interests and offered insightful solutions on how to disincentivise switching to formula feeding within BMS trials.