Sex to be considered as an experimental variable by BJP

The British Journal of Pharmacology (BJP) has released an editorial recommending that findings published in the journal from now on should formally address the sex of models in pre-clinical studies as an experimental variable.

The report demonstrates that when studies are conducted solely on males, data can become biased and this can affect successful translation into a clinical setting.

The Editor-in-Chief and Senior Editors of the journal, who wrote the editorial, explain that sex influences physiology and the response to medicines. Therefore, understanding this and awareness in pre-clinical research can help ensure a smooth transition from clinical development into practice.

The writers highlight that sex needs to be a variable, otherwise studies will be biased towards males only.

The editorial also comments that if both sexes are used in research there is potential to minimise the number of animals used for experiments, as many surplus animals bred for scientific procedures will be females.

Editor-in-Chief of the BJP, Professor Amrita Ahluwalia, summarised the new policy, saying: “This new policy means that the BJP now requires sex to be considered as an experimental variable for all experimental reporting. This will affect the details of the experimental design that are documented or, in the absence of a design incorporating both sexes, a full justification for that approach.

“We recommend that all experiments (in vitro, in vivo and ex vivo) should ideally include both sexes, unless there is a specific justification or exemption, such as when using immortalised cell lines or tissue derived from a sex organ. Our hope is that by requiring a statement upon sex from authors we raise the profile of this important issue within the international pharmacology community.”