Docket Management
Docket: 02D-0018 - Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Prodcuts; Draft Guid
Comment Number: EC -5

Accepted - Volume 1

Comment Record
Commentor Ms. Helle Gawrylewski Date/Time 2003-03-31 16:53:01
Organization DIA - Medical Writing SIAC Standards
Category Association

Comments for FDA General
1. General Comments Division of Drug Information [Docket No. 02D-00181] March 28, 2003 Dockets Management Branch, Included are comments to Draft Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials from members of the DIA Medical Writing SIAC Standards Subcommittee; these comments do not reflect any official opinion of the Medical Writing SIAC or DIA. The stated purpose of the guidance is to facilitate and to enhance data consistency and comparability so information about differences in product effectiveness and safety for population subgroups can be used to improve the use of specific drugs and ostensibly public health. The categories suggested are certainly an improvement but may not result in the desired consistency. Scientific accuracy and consistency of OMB categories · OMB categories serve to measure sociologic factors but have questionable relevance for drug development. In order to determine genetic differences in drug metabolism or response, a true biologic marker would be the best predictor. The proposed categories, even if precisely executed, stand little chance of matching patient subpopulations with the most beneficial treatments. · Self-reporting is not a particularly accurate way to solicit this information. Self-designation is problematic and fraught with issues and sensitivities. Past experience indicates that Hispanic subjects do not necessarily consider themselves “White” but would check “Other” (a choice provided on many CRFs) By the same token, subjects in India may consider themselves “White”, “Other” but often not “Asian”. A recommendation for lines 169 forward would be to add a more complete description of what can be included under each category or to include the country of origin of parents or grandparents in the questioning. This information can then be used to map more accurately to the recommended categories. · The two-question format could lead to confusion. If “Hispanic” ethnicity is checked, would “White” also be required or assumed, and does the choice of “Black” indicate multiracial background? · It is suggested that subjects be allowed to identify themselves as multiracial (lines 151-155). In cases of multiracial identity, what would be the specific data summary rules, as the OMB standards of 1997 require statistical analysis to provide detailed distributions, including all possible combinations? Would this type of complexity add or detract from the desired consistency? It could be useful to indicate how people should record their multiracial background (e.g. with respect to their parents or grandparents, etc) to aid in computing demographics data. A minor point related to consistency, the guidance mentions multiracial but not multiethnic background (e.g. Latino mother, non-Latino father). Standards for a multiethnic background should be mentioned for consistency and clarity. Applicability of Categories outside the US For the recommendation for trials conducted outside the United States (lines 178 on), have these OMB categories been reviewed and agreed to in Europe or have they been discussed in some ICH forum? As noted in the CDISC discussions about variable names, the variable of “race” itself is required by FDA but with ongoing discussions in Europe about the permissibility of collecting these data, the variable may be optional in the future (CDISC Submission Data Domain Models v 3.0, March 17, 2003). Global applicability of any racial and ethnic categories cannot be ignored. More appropriate categories would be needed for multinational companies doing research in Australia, for example, and other areas. Consideration should be given to classifications in line with ICH E5: This section should summarize safety data pertinent to individualizing therapy or patient management on the basis of demographic and other factors defined as intrinsic ethnic factors in ICH E5. These factors include age, sex, height, weight, lean body mass, genetic polymorphism, body composition, other illness, and organ dysfunction. This section should summarize safety data pertinent to individualizing therapy or patient management on the basis of factors defined as extrinsic ethnic factors in ICH E5. These are factors associated with the patient environment. Examples are the medical environment, use of other drugs (see Section Drug Interactions), use of tobacco, use of alcohol, and food habits. In summary, the proposed racial and ethnic categories may not consistently confer the most accurate information about a subject’s genetic or cultural heritage without some guidance, particularly if reliance is made exclusively on self-reporting. It is hoped that advances in pharmacogenomics and pharmacogenetics will enable us to determine much stronger linkages between data collection categories and biological responses than the ones proposed. Yours sincerely, Helle Gawrylewski and Barbara Kamm, Co-chairs Medical Writing SIAC Standards Subcommittee

EC -5