Exploratory physiological experiments are not clinical trials

Several scientific journals have recently adopted the guidelines of the International Committee of Medical Journal Editors (ICMJE) for the registration of clinical trials.

As a result, exploratory physiological experiments in healthy individuals investigating a “behavioral treatment”, such as the effects of diet or exercise, may now be declared as “clinical trials”.

Therby, the ICMJE guidelines are often not appropriate for exploratory physiological experiments, as these studies are often hypothesis-generating and focused on reveiling novel mechanisms rather than focusing on a disease outcome in patients, as is usually the case with clinical trials.

The article argues that it is inappropriate to force exploratory physiological experiments to a rigid registration process and to tie them to primary and secondary outcomes intended for clinical trials.

The researchers call for journals that publish exploratory physiological experiments to apply the ICMJE guidelines only if the study is truly a clinical trial. Various solutions are proposed, for example that the clear definition of what constitutes a clinical trial could be adopted by the European Union.

The article was supported by 95 scientists, including Prof. Dr. Andreas Birkenfeld, DZD spokesperson and Medical Director of the Department of Diabetology, Endocrinology and Nephrology, University Hospital Tübingen, and shows that there is a strong consensus in the scientific community for more appropriate and differentiated guidelines.

Original publication:
Richter, Erik A.; James, David E.; Kirwan, John P.; Zierath, Juleen R. (2024): Exploratory physiological experiments are not clinical trials. In: Cell metabolism. DOI: 10.1016/j.cmet.2024.04.005

Link to the publication