Andre Marette

Forcing such trials to conform to a rigid registration process defining primary and secondary outcomes designed for de facto clinical trials is undermining human physiological research, and this requirement should be abolished.

Contemporary experimental physiological trials are often focused on revealing mechanisms to determine how a particular intervention, such as exercise or a diet, affects a particular physiological outcome and are thus hypothesis generating rather than hypothesis driven.

We contend the ICMJE’s guidelines are unsuited for experimental physiological studies, as the outcomes of physiological experiments demonstrate the remarkable adaptability of the human body and are not consistent with clinical trials in patients, where the focus is on a disease.

This implies that even basic mechanistic studies on exercise or diet, as well as physiological studies on healthy individuals undergoing exercise training, are now being labeled as "clinical trials" due to their potential health-related physiological outcomes.

ICMJE defines clinical trials as "any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome".

Exploratory physiological experiments are not clinical trials. Letter to the Editor at Cell Metabolism authors.elsevier.com/a/1i%7E…

We urge journals to adopt a more flexible stand, abandon the ICMJE guidelines and perhaps use a questionnaire for authors to fill out when submitting a paper that then determines if a study is a clinical trial or an experimental physiological study.