FDA has published a draft Guidance for Industry to recommend categories for collecting effectiveness and safety data during clinical trials for ethnic and racial demographic groups.
FDA regulations require drug sponsors to present an analysis of data according to age, gender and race. An analysis of modifications of dose or dosage intervals for specific groups is also required when manufacturers submit a new drug application for approval by FDA. To accomplish this, FDA recommends that the drug manufacturers use the OMB race and ethnicity categories during clinical trial data collection to ensure consistency in evaluating potential differences in drug response among racial and ethnic groups.
Some differences in response to medical products have already been observed in distinct groups of the U.S. population. These differences may be attributable to intrinsic factors such as genetic differences; to extrinsic factors like diet, environmental exposure, socio-cultural issues, or to interactions between these factors. For example, in the United States, whites are more likely than people of African or Asian heritage to have low levels of an important enzyme (CYP2D6) that metabolizes antidepressants, antipsychotics, and beta blockers. Additionally, of some drugs in the psychotherapeutic class, slower enzyme metabolism has been observed in persons in the United States of Asian descent as compared to Whites and Blacks. Other studies have shown that Blacks respond less to several classes of antihypertensive agents (beta blockers and angiotensin converting enzyme (ACE) inhibitors). Racial differences in skin structure and physiology have been noted that can affect response to dermatologic and topically applied products. Clinical trials have demonstrated lower responses to interferon-alpha used in the treatment of hepatitis C among Blacks when compared to other racial groups.
Although the regulations governing medical devices do not include requirements for the collection of demographic data comparable to those for drugs, for those cases in which race and ethnicity data are necessary to determine the safety and effectiveness of a device, FDA encourages sponsors to collect the data in accordance with the OMB information collection standards discussed in this guidance document. Sponsors are also encouraged to discuss any race or ethnicity issue with the appropriate review division within the Office of Device Evaluation, Center for Devices and Radiological Health, when developing their study protocols.
Collecting race and ethnicity data using standardized categories will enhance the early identification of differences in response among racial and ethnic groups during the evaluation of safety and effectiveness of FDA-regulated products.
Furthermore, collection of this data using standardized categories will facilitate comparisons across studies analyzed by FDA and with data collected by other Federal agencies.
The draft guidance does not discuss increasing the number of studies in which certain groups are exposed to a product, nor does it discuss increasing the total number of participants involved in clinical trials.