The removal of pages linking to diversity in clinical trials and healthcare is “disappointing”, according to pharma experts who believe the industry will continue as normal due to the scientific justification for improving diversity in clinical trials.

Clinical trial diversity has been a notable talking point recently, with sponsors pushing to make more inclusive and diverse research studies. Despite this, one of the first executive orders that President Donald Trump signed upon entering the White House on 20 January was to end what he termed “radical and wasteful” government diversity, equity and inclusion (DEI) programmes.

Following this order, several pages on the US Food and Drug Administration’s (FDA’s) and National Institute of Health (NIH) websites covering diversity were delisted from the site, sparking concern among many in the clinical trial sector that the DEI order could affect clinical trial enrolment after so many years of work to try and boost diversity in studies.

While some pages have now been restored, NIH pages detailing the work of the “Sexual & Gender Minority Research Office” and “Sexual & Gender Minority Health Scientific Research Group”, and the Office of Research on Women’s Health sex and gender landing page remain inaccessible at the time of publication.

Just before Joe Biden left office, two pieces of guidance were published. These were the Sex- and Gender-Specific Data Draft Guidance and the Study of Sex Differences in the Clinical Evaluation of Medical Products draft guidance, both of which remain unavailable on the site at the time of publication. In June 2024, the FDA released draft guidance on diversity action plans in clinical trials. This FDA draft guidance remains available on the agency’s website.

Jackie Kent, a pharmaceutical executive with nearly 30 years of clinical trial experience, and one of the directors for clinical trial solutions platform Jumo Health, said there was disappointment among peers after the diversity pages were taken down.

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“People are disappointed that those sites were removed. We have been working on diversity – or as I call it, inclusive clinical research because it’s not just about race – it’s race, religion, gender, sexuality and disabilities – for five years. Although the FDA guidance has made it easier to enforce, the need for it and the push for equity has been there way before this guidance,” said Kent.

Despite concerns about the pages being removed, Kent does not believe that these changes will have a large impact on trials. A result of how much the industry has pushed for these developments as well as the evident scientific justification around diversifying patient populations in trials.

Kent added: “It’s disappointing that we are on this path, but I do not believe it’s going to change the way we look at enrolling clinical trials in a way that we have been working towards, because we have been doing it a lot longer than just the guidance has been in place.

“I look to pharma to continue to do things the way they have been doing them because we have raised the bar over time without regulation or legislation. We started this because we wanted a more scientific, rigorous clinical trial so the prevalence of the disease needs to be the populations we are studying it on. I do not think pharma is going to want to change that focus. Legislation makes it easier and more consistent, but I think the industry’s focus on executing safe and high-quality science.”

Joshua Travis, associate director of ALZBrainTrust at the Alzheimer’s Association, says that whilst he believes that pharma companies will try to continue the push for diversity in clinical trials, he fears that companies who collaborate with pharma and rely on government grants may be impacted.

“There are concerns that although pharma companies might not be punished, grant-receiving organisations may be. If they work with pharma companies that continue to push diversity, they could receive retaliation with funding efforts through federal grants,” Travis explains.

“Although I  feel that pharma will continue to focus on it, I unfortunately, see that non-profit organisations may have to prepare for retaliation from the administration if they continue to work with organisations that prioritise DEI.”

Many major pharma companies based in the US, including pharma giant Eli Lilly, still have DEI pages available on their websites for both staffing and clinical trials.

On 16 January, a European supergroup was formed to boost diversity in clinical trials. The new pan-European group of 73 regulators, companies and trial sites is backed by €66.8m in funding with a six-year goal.