Will the new US administration’s move away from DEI policies impact women’s involvement in clinical trials?

Incoming US President Trump has issued numerous Executive Orders immediately on taking office, and these include an Executive Order to remove all diversity, equity and inclusion (DEI) mandates, policies, programmes, preferences and activities in the Federal Government. This has led to concern in the women’s healthcare and life sciences sectors that efforts to address inequality in clinical research will be affected.

One example is a draft guidance document, “Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies”. This was published on 7 January and was intended to encourage science-driven consideration of sex and/or gender in relation to medical device clinical studies. However, it is no longer accessible at the relevant link.

Traditionally, clinical trials have tended to exclude women as participants. The reasons for this range from understandable concerns about potential harm to a foetus where a woman may not be aware that she is pregnant, to a historical bias favouring men as the “normal” study population. Eligibility to participate in early-stage clinical trials focuses on the recruitment of healthy volunteers, normally requiring participants to be relatively young, and coinciding with a woman’s reproductive years.

The response of the body to a particular medicine may vary considerably between men and women due to factors such as body weight and composition, renal clearance and hormonal influences. The dosage required for a female patient is often different, and symptoms and adverse reactions may vary widely.

Women have often been poorly served as a result. Initiatives to promote diversity among clinical trial participants are being widely deployed to address these issues, including in industry (eg GSK initiative on gender diversity in clinical trials), in legislation (eg the requirement to assess whether the groups of subjects participating in the clinical trial represent the population to be treated in the EU Clinical Trials Regulation), and in guidance (eg the UK HRA and MHRA draft inclusion and diversity guidance). 

Given the real-world impact of discrepancies in participation between women and men in clinical research, it is to be hoped that the US Federal Government will recognise the need to address them under the new administration. In any event, requirements being introduced elsewhere, together with clinical trial sponsors’ own initiatives bring a momentum that we expect will see continued progress in this area.

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