FDA outlines plans for racial and ethnic diversity in clinical trials
28 Jul 2022
On 13 April, 2022, the FDA (Food and Drug Administration) issued a press release outlining their plans to develop a strategy to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials. This expands on the FDA's previous guidelines for industry improvements for clinical trial diversity.
Clinical trials are a major part of getting medical products, such as medications, medical devices and vaccinations, to market, ensuring both patient safety and drug effectiveness. Clinical trials, or research studies, involve human volunteers and their evaluation of the medical products.
The FDA has started a program, Project Equity, which is directly responsible for generating evidence for diverse populations in Oncology. This program is of immense importance in improving access to clinical trials in populations that historically have been underrepresented in clinical research due to race, ethnicity, sex or gender minority and living in rural areas. This also will work to improve access for individuals with economic, linguistic, or cultural barriers to healthcare services. The FDA's recent announcement encourages diverse participation to be included in clinical trials to encompass health equity, as there is a great need to have people of different ages, races, and ethnicities involved in order to capture data on reactions to medical products. To date, participation from racial and ethnic minorities and other diverse groups is underrepresented in clinical research.
However, the FDA recognizes that there are barriers that must be removed to achieve diverse enrollment. These barriers include mistrust of the clinical research system, inadequate recruitment and retention efforts, study visit frequency, resource and time constraints, transportation challenges, and participation scheduling conflicts with caregiver or family responsibilities. Further to these challenges, a large barrier is caused by language and cultural/religious differences, health literacy and the lack of awareness and knowledge of what a clinical trial is and what participation could involve.
Although many translated documents are required for the full clinical trial process, Clinical Outcome Assessments (COAs) may be one of the most significant. COAs are a key element of data capture for many clinical studies, as they allow patients to provide information as to how their condition, and the subsequent treatment, impacts their symptoms and overall Quality of Life. Ensuring that these COAs are available to all participating patients will be a key consideration in adhering to the FDA guidance on increasing diversity. Sponsors will need to consider the linguistic requirements for a larger number of languages, providing opportunities for all enrolled patients to complete COAs and therefore contribute critical data.
At RWS, we have expert teams who already understand the need for understanding diverse participation within clinical trials and have a great record for assisting sponsors to allow more diversity in their studies through linguistic solutions. We understand language, cultural and religious differences, and how these may impact individual patient understanding. Our teams have been diligently working with patients and linguists to enable correct and highly accurate translations for the entire clinical trial process, adhering to the rigorous linguistic validation procedures required.
To effectively plan for more diverse studies moving forward, it is important to understand the language use of a particular country; how different populations have introduced new languages and culture; and how some languages have morphed over time when influenced by the culture around them. Therefore, we must consider:
- How long a language has been in use
- The country of origin and;
- Whether the target population has integrated and therefore been influenced by the established culture and languages that surround them.
Then we have to consider the intended meaning of the COA and whether it is appropriate for all countries where the target language is used. The English source may ask the patient how easy it was for them to have a shower, for example, to determine their mobility and independence in completing self-care tasks. This seems simple, however, one would have to take into consideration that in some countries access to clean water and indoor plumbing may not be as common, meaning the question itself may not be appropriate and would need to be adapted for the target audience, while still capturing the same key concepts.
Translations are an essential component of moving global clinical trials forward. Our focus in translating documents for the life sciences industry has made us experts in analyzing clinical trial documents and delivering the most appropriate translation methodologies.
Although the U.S. FDA has made this announcement, we need to think beyond the U.S. as this truly is a worldwide topic. As populations move and language evolves, there is much planning that must occur in order to ensure that the clinical trial process is accessible for patients of diverse backgrounds. Planning on how you will incorporate more racial and ethnic diversity into your clinical trials is the first step. The more thoroughly you plan, the more successful a clinical trial you will have. RWS are the experts in walking our clients through these considerations. Click here to learn how our team can help you prepare linguistically for a successful and diverse clinical trial.