LGBTQIA+ people are being erased from clinical trials by poor data collection

What is it about?

Clinical trials routinely collect demographic data on sex and gender, but the way these questions are designed frequently conflates sex and gender, treats them as interchangeable, or offers only binary response options that exclude non-binary, transgender and intersex participants. Sexuality is similarly affected by what the authors call "othering," where LGBTQIA+ identities are collapsed into a catch-all "Other" category rather than being meaningfully captured. This commentary by Williams, Hood, Bracken and Shorter, published in Trials in 2023, sets out why this matters for trial quality and equity, examining how sex or gender is used as a stratification factor at randomisation and in subgroup analysis, meaning inaccurate data collection propagates into the science itself. The paper reviews current practice, identifies the harms of invisibility for LGBTQIA+ people in health research, and argues for standardised, inclusive demographic data collection that distinguishes sex assigned at birth, gender identity and sexuality as separate constructs.

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Why is it important?

Excluding or misclassifying LGBTQIA+ people in clinical trials produces evidence that does not apply to their health needs and perpetuates health inequalities in treatment and care. The paper arrives at a moment when regulators, funders and trial networks are under increasing pressure to embed diversity and inclusion into trial design, yet practical guidance on how to collect sex, gender and sexuality data accurately and inclusively in trials has been limited. The publication in Trials, the leading international trials methodology journal, positions this argument at the heart of the trials methodology community and addresses the structural conditions that determine who benefits from clinical trial evidence and who is systematically left out.