Docket Management
Docket: 02D-0018 - Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Prodcuts; Draft Guid
Comment Number: EC -4

Accepted - Volume 1

Comment Record
Commentor Dr. Michael Scotti Date/Time 2003-03-13 11:12:23
Organization American Medical Association
Category Association

Comments for FDA General
Questions
1. General Comments To: Food and Drug Administration On behalf of the American Medical Association (AMA) and its Minority Affairs Consortium, we are pleased to respond to the Food and Drug Administration (FDA) request for comment on Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials. The AMA commends the FDA for its efforts to encourage and standardize the collection of race and ethnicity information. We believe that the identification and analysis of such data is an important component in the elimination of racial and ethnic health care disparities. The AMA supports the FDA recommendation to use the Office of Management and Budget (OMB) guidelines for collecting race and ethnicity information in clinical trials in cases where race and ethnicity data are relevant to determining the safety and effectiveness of FDA regulated products. Use of the revised OMB guidelines (Policy Directive 15) will help ensure consistency across studies used to support marketing applications to the FDA and across data collected by other government agencies. It will also be useful in evaluating potential population differences in the safety and efficacy of pharmaceutical products among different population groups. The FDA recommendation is consistent with AMA policy H-350.983 which supports the use of the OMB guidelines for the collection of data on race and ethnicity until more scientifically rigorous standards are available. It is also consistent with AMA policy H-460.924 recognizing race and ethnicity as valuable research variables when used and interpreted appropriately and which encourages appropriate organizations to apply the results from studies of race-ethnicity and health to the planning and evaluation of health services. Full text of these two policies can be found below. Thank you again for the opportunity to comment. Sincerely, Michael J. Scotti, Jr., MD AMA Senior Vice President,Professional Standards Kevin McKinney, MD AMA Minority Affairs Consortium Governing Council Chair AMA Policies H-350.983 Federal Guidelines for Standardization of Race/Ethnicity Codings The 1997 revised Office of Management and Budget guidelines should be used for the collection of data on race and ethnicity until more scientifically rigorous standards are available. Common Data Elements, as specified by the Standards and Liaison Committee of the Health Information and Surveillance Systems Board, should be used if greater specificity in coding is required. (BOT Rep. 23, A-98; Reaffirmed: CLRPD Rep. 3, I-98; Modified: CSA Rep. 5. I-00; Reaffirmed: Res. 509, A-01) H-460.924 Race and Ethnicity as Variables in Medical Research Our AMA policy is that: (1) race and ethnicity are valuable research variables when used and interpreted appropriately; (2) health data be collected on patients, by race and ethnicity, in hospitals, managed care organizations, independent practice associations, and other large insurance organizations; (3) physicians recognize that race and ethnicity are conceptually distinct; (4) our AMA supports research into the use of methodologies that allow for multiple racial and ethnic self-designations by research participants; (5) our AMA encourages investigators to recognize the limitations of all current methods for classifying race and ethnic groups in all medical studies by stating explicitly how race and/or ethnic taxonomies were developed or selected; (6) our AMA encourages appropriate organizations to apply the results from studies of race-ethnicity and health to the planning and evaluation of health services; and (7) our AMA continues to monitor developments in the field of racial and ethnic classification so that it can assist physicians in interpreting these findings and their implications for health care for patients. (CSA Rep. 11, A-98; Appended: Res. 509, A-01)




EC -4