Policy to Support Inclusive Research and Experimental Design

British Pharmacological Society

Sex differences influence physiology and our response to medicines. Considering these differences in pre-clinical research can help ensure a smooth transition from clinical development into practice. However, in reality, research is biased towards males – partly due to inconsistent (or lack of) consideration of sex as an experimental variable. Not only can masking sex differences lead to problems with translation or reproducibility, a bias towards studying male physiology and the male drug response may also be harmful if this leads to inappropriate treatment recommendations for females[1]. Therefore, incorporating both sexes in pharmacological research will be critical step towards gender equality in science and healthcare – and an important one on the journey to truly personalised medicines. We are proud that the British Journal of Pharmacology (one of the Society’s three journals) is helping lead the way with a new policy recommending that all future studies published in the Journal should formally address sex as an experimental variable.

An accompanying editorial[2] discusses the issues and the important role of journals in setting standards in experimental design. 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.”

The Journal accompanied this new policy with a themed special issue, entitled ‘The importance of sex differences in pharmacology research’[3], with a selection of reviews and research articles clearly demonstrating the need to study males and females. Accordingly, the Society’s clinical journal, the British Journal of Clinical Pharmacology, will be following the BJP’s lead with a series of articles on this topic, including on clinical trial design.

The Society is committed to removing barriers to participation and success, while welcoming equality and celebrating diversity, and being inclusive in all we do. To ensure that everyone has the opportunity to benefit from pharmacology, all aspects of research must be inclusive by design. We look forward to working with our journals to understand the impact of such policies, what we can learn from them and our role in continuing to set standards.

[1] Franconi F. et al (2007) Gender differences in drug response. Pharmacology Research 55 (2):81-95. Available online at: https://www.sciencedirect.com/science/article/abs/pii/S1043661806002040?via%3Dihub

[2] Docherty J.R. et al (2019) Sex: A change in our guidelines to authors to ensure that this is no longer an ignored experimental variable. British Journal of Pharmacology 176 (21) 4081 – 4086. Available online at: https://bpspubs.onlinelibrary.wiley.com/doi/abs/10.1111/bph.14761

[3] Gogos A. et al (2019) Special issue: the importance of sex differences in pharmacology research. British Journal of Pharmacology 176 (21) 4079 – 4242. Available online at: https://bpspubs.onlinelibrary.wiley.com/toc/14765381/2019/176/21