How can diversity in clinical trials be improved?

What’s happening? The National Institute on Aging (NIA) has launched Outreach Pro, a tool aimed at helping researchers and clinicians raise awareness about Alzheimer’s drug trials and encourage more diverse participation. Older Black and Hispanic Americans are twice and 1.5 times as likely, respectively, to have Alzheimer’s than their white counterparts, but the majority of clinical trials feature white patients. Among Outreach Pro’s resources are websites, social media, handouts and videos in English and Spanish, with other languages spoken by Asian-Americans and Native Americans following in the coming months. (Fierce Biotech)

Why does this matter? Clinical trials for all treatments need to be more diverse in the participants they recruit – different populations experience health conditions in varying ways and treatments can have different levels of success. Minority groups, older people and women have been historically underrepresented in clinical trials. More needs to be done to improve inclusivity to ensure treatments are effective for them.

Once a drug, device, or any other therapy is approved, people may also want to understand if it has been trialled among their population. This issue was put under the spotlight when people of colour expressed hesitancy about getting a Covid-19 vaccine as they started becoming available for fear of being part of an experiment, despite this group being at disproportionately greater risk of the disease. Clinical trial inclusivity is therefore also important to build trust among potential treatment recipients.

Opening up – While eligibility criteria are essential, they are sometimes too restrictive and can screen out potentially suitable participants. Where possible, trial designers should look at how this can be expanded to include a larger number of participants from a wider range of backgrounds.

Reaching out – Researchers can also increase diversity by reaching out to their target population to build trust so they may be more interested in participating in a trial. This could be via patient advocacy groups and forming partnerships with community-based medical centres. Roche company Genentech is taking this approach by pairing with research centres in areas with higher Black and Hispanic/Latinx populations to improve diversity in its cancer studies.

Going virtual – Technology also presents an opportunity to reach more potential participants with decentralised or virtual trials, which gained popularity over the Covid-19 pandemic. Reducing or even eliminating the need to attend a trial centre where permissible makes it easier and more attractive for someone to commit to participating. Apps, wearables and other devices can collect valuable data, while telemedicine can keep researchers and participants in touch to discuss how things are going and to identify any potential issues.

Raising awareness – Just as Outreach Pro is attempting to do, making people more aware of clinical trials that are recruiting and the criteria needed via a range of channels would also attract a larger pool of participants. Easy-to-navigate registries with appropriate and easy-to-understand information alongside simpler application processes could help with this.

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