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FDA Unveils Clear Guidelines for Demographic Data in Applications
(Thursday, February 1, 2024) It has been required since 1998 that race and ethnicity information be presented with clinical trial results included in market approval applications for all FDA-regulated products. However, there exists signification confusion about the specific demographic sub-groups that should be collected and the standardized approach that should be followed leading to variability in the reported data. This is reflected in the lack of diversity in populations included in pivotal clinical trials for practically all products approved in the last 20 years. This week the FDA released a new Guidance Document to clarify its expectations about this topic. The regulations state that the “sponsors of investigational new drugs and investigational devices should enroll participants who reflect the population that will use the medical product if approved.” There are well-documented differences in response to medical products between different racial and ethnic groups. These differences can be attributed to intrinsic factors such as genetics, and extrinsic factors such as diet and socioeconomic status. Hence, it is important to map safety and effectiveness data to various demographic groups included in clinical trials to adequately evaluate the risk-benefit profile of a given product. The new FDA Guidance Document released this week lists specific expectations regarding the collection of demographic data in clinical trials and the process that should be followed for the same. The newly released guidelines outline a structured approach. Participants should be posed two pivotal questions: "Are you Hispanic/Latino or not Hispanic/Latino?" and "What is your race?" The second query presents a menu of options: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White. Participants can choose more than one option for the race question to address the real-world diversity in the US population. Ensuring authenticity, the FDA stresses that trial participants must self-report race and ethnicity, steering clear of any influence by the study team. Furthermore, the study team is mandated to cross-verify the reported data with participants' medical records, fostering accuracy and transparency. The participants should be permitted to report their ethnicity and race as they want, even if it is different from what is reported in their medical records. Sponsors are permitted to use higher granularity in reporting ethnicity and race information so long as it is aligned with the two questions described above. Specific race must be specified; the document explicitly says that the term “nonwhite” is not acceptable. FDA expects demographic data, categorized by race and ethnicity, to be an integral part of all clinical trial and market approval applications. The demographic information must be included in the product labels as well. The new Guidance Document provides clarification for common questions about the standardized collection of race and ethnicity information in FDA submissions that should help reduce variability in reports of such information. Since awareness leads to corrections, being aware of the demographic distribution in their trials, should coerce sponsors to work harder to increase diversity in their trials so that the trial population “reflect the population that will use the medical product, if approved”. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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