January 23, 2024
The decades long challenge to achieve diversity among clinical trial participants has been prioritized by the 2022 passing of FDORA (Food and Drug Omnibus Reform Act). Working in an industry that is so regulated and standardized, it’s easy to feel overwhelmed by the new requirements. This month I’ve been focusing on simple strategies researchers can implement that help increase diversity and retention rates of volunteer participants. Regular updates can positively influence clinical trial diversity and the ways in which researchers can keep volunteers and patients informed throughout the process.
*Please keep in mind volunteer privacy is the key to building trust; using data anonymization and a consent-based update process ensures participants receive the communication without risking their privacy. Participants must consent to receiving access to secure portals, emails, newsletters, phone calls, regular in-person meetings with volunteers & staff, video updates, and/or mailers.
Why should participants consent to receiving regular updates? And why should the clinical research staff, already facing tight timelines, make updating volunteers a priority? This week let’s answer these questions and dive into the benefits of providing regular updates to participants:
Fostering Trust and Engagement: Regular updates help build trust between the clinical research staff and the participants. By keeping volunteers well-informed about the trial's progress, they feel valued and appreciated. This sense of engagement can encourage participants from diverse backgrounds to actively contribute to the study. By keeping volunteers and patients well-informed about the trial's progress, they feel valued and appreciated. This sense of engagement can encourage participants from diverse backgrounds to actively contribute to the study, thus promoting diversity.
Openly Address Concerns and Misconceptions: Each diverse community has unique concerns and may have unique misconceptions about clinical trials, which can hinder their participation. Regular updates provide an opportunity for clinical research staff to clearly address these concerns and clarify any misconceptions. By openly addressing participants' questions and fears, researchers can alleviate anxieties and increase the likelihood of diverse individuals participating in the trial.
Highlighting the Importance of Diversity: Through regular updates, clinical research staff can emphasize the significance of diversity within clinical trials. By sharing relevant findings or developments related to diverse groups, researchers can demonstrate the real impact that participants from different backgrounds can have on medical research. This approach helps participants feel valued and appreciated, encouraging them to continue their involvement while attracting others from diverse communities.
Tailoring Communication to Reach Diverse Communities: Effective communication is key to engaging with diverse communities. Clinical research staff should be mindful of the various cultural, linguistic, and accessibility needs of potential participants. By using inclusive language, translating materials into different languages, and providing accessible formats, researchers can ensure that updates reach a wider audience. This approach demonstrates a commitment to inclusivity and encourages diverse participation.
Collaborating with Community Partners: Collaborating with community organizations, patient liaison groups, patient advocacy groups, and community leaders who have established trust within diverse communities helps promote clinical research education. By involving trusted community members in the research process and leveraging their influence, researchers can enhance the outreach and impact of their regular updates. This partnership can facilitate more effective communication and encourage greater participation from diverse populations.
Providing regular trial updates to consenting participants plays a significant role in influencing diversity within clinical trials. By keeping volunteers and patients informed about the trial's progress, clinical research staff can foster trust, address concerns, highlight the importance of diversity, tailor communication, and collaborate with community partners. These efforts not only promote inclusivity but also contribute to the overall success and validity of clinical research. By embracing regular updates as a tool for diversity, clinical research staff can help shape a more equitable and representative future for medical trials.
References:
Willis, A., Isaacs, T., & Khunti, K. (n.d.). Improving diversity in research and trial participation: The challenges ... The Lancet Public Health. https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(21)00100-6/fulltext
Kahn, J. M., Gray, D. M., Oliveri, J. M., Washington, C. M., DeGraffinreid, C. R., & Paskett, E. D. (2022, January 15). Strategies to improve diversity, equity, and inclusion in clinical trials. Cancer. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293140/
Tan, R. K. J., Wu, D., Day, S., Zhao, Y., Larson, H. J., Sylvia, S., Tang, W., & Tucker, J. D. (2022, March 25). Digital approaches to enhancing community engagement in clinical trials. Nature News. https://www.nature.com/articles/s41746-022-00581-1
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