Every day, there are literally hundreds of thousands of ongoing clinical trials worldwide. A significant issue for regulators and trial sponsors is ensuring that the clinical studies are accessible to any interested person and that the trial populations reflect the real-world patient populations as much as possible in terms of ethnicity, race, sex and age. In March 2020, the U.S. Food and Drug Administration (FDA) issued a draft guidance1 stating that trials should include "an adequate representation of the range of patients" that might use an approved drug or medical product to "maximize the generalizability of the trial results."
Sadly, COVID-19 is a good example of diseases that do not affect populations uniformly. There are significant differences in how the disease affects people by age — with the elderly hardest hit. Clinical trials for the COVID-19 vaccines and therapeutics have stressed the importance of including a broad range of ethnicities, races, age groups, and sex.2 All of which represent a challenge for stakeholder communication during recruitment and retention of the clinical studies.
Reaching Broader Audience with Appropriate Language
Most people in the U.S. have some sort of access to the Internet — a Pew Research Center3 study found that in 2021, 93% of adults use the Internet. However, 15% are smartphone-only Internet users. The disparities seem to correlate to household income and education, with lower income and less educated individuals not as likely to have broadband at home. One of the keys to reaching a broader audience for clinical trials is to get the trial recruitment and protocol information to participants where they are—which often means print as well as digital.
Kevin Kaiser, National Account Manager with FedEx Office, says, "When talking about the strategic use of direct mail, for example variable data, we can create a unique image and message for each piece of mail that goes out to potential trial participants. The benefits of using this platform can be profound, as our response rates on direct mail are often in the 40% to 60% range depending how you target that message to the potential participants you want in your trial."
In addition, clinical trial communications can be complex, including legal documents, informed consents, and study results. It's important that these communications be written in plain language that people can understand.4 Sometimes this means targeting audience literacy levels5, as well as having documents translated into appropriate languages, such as Spanish, Arabic or others.
Cultural Sensitivity
From a strictly biological perspective, diseases do not affect people uniformly. There are differences, often major differences, between age, race and ethnicity, and sex, in how severe or prevalent certain diseases are. For example, hypertension, one of the leading causes of cardiovascular disease in the U.S., is more prevalent in Blacks than Whites, but also higher in Hispanics.
A Tufts Center for the Study of Drug Development study analyzed demographic data6 from 757 pivotal clinical trials that supported 341 FDA New Drug Applications (NDA)s and Biologic License Applications (BLAs) between 2007 and 2017. The study found that Black, Hispanic/Latinx and Other (Indigenous communities) were underrepresented in the clinical trials while Asian participants were significantly overrepresented.
This underscores not only the need for broader diversity in clinical trials, but the need for communications at all levels to employ greater cultural sensitivity. In May 2019, the American Thoracic Society held a workshop7 that included professionals from academia, industry, the National Institutes of Health and the FDA to develop a framework for improving recruitment and retention of minorities into clinical research. Their conclusions included engaging with patient advocacy groups, leading with community engagement, addressing social and structural barriers, diversifying the research teams, and to "provide language-congruent materials and use plain language in consent and study information."
Cultural sensitivity is of vital importance to clinical trial diversity. For example, one study found over 80% of healthcare workers often or sometimes found it more difficult to engage with or treat patients from cultures different to their own.8,9
Having that baked into your communications strategy is one key to clinical trial success.
Kaiser notes, "At FedEx office, we are in the business of delivering your communications in the most efficient and economical fashion to achieve the results needed. We're the vehicle to engage any audience our customers are trying to approach and can advise our customers on the best way to target a specific group in any format they choose."
To learn more about how FedEx Office can help your business communicate important messages through print, visit fedex.com/businesssolutions today.
Sources
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"Inclusion of Older Adults in Cancer Clinical Trials: Guidance for Industry." U.S. Food and Drug Administration, March 2020. https://www.fda.gov/media/135804/download
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"Clinical Trial Diversity and Accessibility: Recruiting a Diverse Patient Profile While Managing the Resulting Data Demands." Industry Outlook Report. 2020 Q4. BioPharma Dive. https://resources.industrydive.com/clinical-trial-diversity-and-accessibility
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Internet/Broadband Fact Sheet. Pew Research Center, April 7, 2021. https://www.pewresearch.org/internet/fact-sheet/internet-broadband
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"How biopharma innovation may benefit from more inclusive print communications." BioPharma Dive. June 28, 2021. https://www.biopharmadive.com/spons/how-biopharma-innovation-may-benefit-from-more-inclusive-print-communicatio/601804/
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Tran BNN, Ruan QZ, Epstein S, et al. Literacy analysis of National Comprehensive Cancer Network patient guidelines for the most common malignancies in the United States. Cancer. 2017. https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.31113
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Getz KA et al. Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017. Ther Innov Regul Sci. 2020;54(6):1541-1550. https://pubmed.ncbi.nlm.nih.gov/32557009/
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Thakur N et al. Enhancing Recruitment and Retention of Minority Populations for Clinical Research in Pulmonary, Critical Care, and Sleep Medicine: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2021;204(3): e26-e50. https://www.atsjournals.org/doi/full/10.1164/rccm.202105-1210ST
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Rishi A. Achieve clinical trial diversity by introducing cultural safety. Couch. February 2021. https://blog.couchhealth.co/achieve-clinical-trial-diversity-by-introducing-cultural-safety
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Shepherd SM, Willis-Esqueda C, Newton D et al. The challenge of cultural competence in the workplace: perspectives of healthcare providers. BMC Health Services Research. February 2019;19(135). https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-019-3959-7