By Benjamin Ross 

November 8, 2016 | The Food and Drug Administration (FDA) recently released a guidance entitled “Collection of Race and Ethnicity Data in Clinical Trials.” The purpose of the guidance is to offer suggestions to researchers conducting clinical trials on how to handle issues as they pertain to race and ethnicity, especially a kind of standardization for collecting and reporting race and ethnicity data. According to the guidance, “Using standard terminology for age, sex, gender, race, and ethnicity helps ensure that subpopulation data is collected consistently.”

The FDA provides a brief background into the decisions that led to composing the guidance within the document. According to the FDA, the agency “publically sought input from a variety of experts and stakeholders regarding the study and evaluation of age, race, and ethnicity in clinical studies for medical products.” The Agency held the first public hearing on the topic on April 1, 2014, which led to public workshops held on April 9, 2015 and December 2, 2015.The workshops were attended by government agencies, physician professional societies, and patient advocacy groups.

The authors of the guidance make the point that, “Differences in response to medical products have already been observed in racially and ethnically distinct subgroups of the U.S. population. These differences may be attributable to intrinsic factors (e.g., genetics, metabolism, elimination), extrinsic factors (e.g., diet, environmental exposure, sociocultural issues), or interactions between these factors.”

There is also evidence to suggest that racial and ethnicity issues play a tangible role in the effectiveness of certain drugs. The guidance points an FDA review of clinical trials between 2008 and 2013, where it was revealed that close to “one-fifth of new drugs demonstrated some differences in exposure and/or response across racial/ethnic groups.” These differences can reveal themselves across racial and ethnic lines through differences in skin structure, which can affect response to dermatologic and topically applied products, and mortality rates in patients on dialysis, which fluctuates across race and ethnicity groups.

FDA recommends a two-question system about ethnicity and race (in that order) for studies “conducted both inside and outside the United States.” FDA also recommends that participants in clinical trials should “self-report race and ethnicity information and those individuals be permitted to designate a multiracial identity.” Designation of race and ethnicity should not be assigned by the researchers conducting the clinical trial.

A fairly extensive list of recommended ethnicities and racial identities includes many possible options. The ethnicity portion is limited to either “Hispanic or Latino” or “Not Hispanic or Latino.” The racial identification section is where the options expand to accommodate the vast majority of the United States’ population. The list of racial identities includes “American Indian or Alaska Native,” “Asian,” “Black or African American,” “Native Hawaiian or Other Pacific Islander,” and “White.”

With this list, the FDA acknowledges that there are circumstances in which more racial and ethnic identity is required. The guidance addresses the issue of complexly integrated races and ethnicities by stating, “for clinical trials conducted outside the United States, FDA recognizes that the recommended categories for race and ethnicity were developed in the United States and that these categories may not adequately describe racial and ethnic groups in foreign countries. Furthermore, White can reflect origins in Europe, the Middle East, or North Africa; Asian can reflect origins from areas ranging from India to Japan.”

With all of the possible racial and ethnic identities, the FDA guidelines explicitly state, “The term ‘nonwhite’ is not acceptable for use in the presentation of Federal Government data. It should not be used in publication or text of any report.”

The FDA’s guidance has potential to significantly expand the vocabulary used in clinical trials. Time will tell of these suggestions will bear the fruit the FDA is hoping for.