4. Look at language. Language barriers are a key deterrent to clinical trial diversity. Once again, however, they may be overcome if tackled early.
Instead of enrolling mainly English-speaking patients first, and then later “catching up” with patients whose first language is not English, sponsors may consider creating multilingual informed consent documents at the same time the English version is created. While there is some risk involved with IRB approvals and cost, the benefit is that sites can begin enrolling English- and non-English-speakers at the same time. Where possible, it can be beneficial to provide patients with access to site staff who both understand the study and speak their language. Patients who can read about and discuss their clinical trial options in their native language are more likely to be engaged and less likely to feel like a study “afterthought.”
5. Be intentional about investigator site selection. Nurturing long-standing relationships with community sites is as essential as deepening patient relationships. Indeed, sites that both serve and reflect diverse communities are the only way to reach those communities. Therefore, sponsors should be prepared to offer transparency and support to investigator sites, especially if they lack experience with clinical trials. This can be done by:
● Committing to continuous conversations with the sites.
● Helping to build capabilities and capacity within inexperienced sites.
● Being transparent about the kinds of patient populations the study team hopes the site can recruit. Diversity of Participants in Clinical Trials Solutions
● Holding sites to the same diversity and equity standards as the sponsor organization.
● Conduct DEI training for sites on topics like implicit bias and inclusive behaviors.
The time is now
Waiting until enrollment begins to engage diverse populations is not an effective way to make clinical trials more diverse, equitable, and inclusive. Diversity must be an integral part of each study’s strategy—defined and entwined into the end to end Clinical Development Lifecycle. More importantly, it must be part of a culture shift that prioritizes long-term relationships as much as speed and quality. However, if we take these steps, we can move toward a more seamless integration of speed, quality, and diversity in our clinical trial ecosystem.
About the authors: Catherine Ofori-Atta is the senior clinical operations lead at Roche. Sandra Amaro is head of clinical trial diversity at Pfizer. Catherine and Sandra collaborate on diversity strategies through TransCelerate BioPharma Inc., a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies.
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