Docket Management
Docket: 02D-0018 - Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Prodcuts; Draft Guid
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Dr. Della Hann Date/Time 2003-03-03 14:02:51
Organization NIH
Category Other

Comments for FDA General
Questions
1. General Comments Recommend changing the wording in Appendix I: National Institutes of Health to read as follows: In 1993, the National Institutes of Health (NIH) Revitalization Act directed the NIH to establish guidelines for including women and minorities in NIH-sponsored clinical research. NIH was directed to ensure that women and minorities were included as subjects, unless their exclusion was justified due to circumstances specified by NIH guidelines. Furthermore, clinical trials should be designed and carried out in a manner sufficient to elicit information about individuals of both genders and diverse racial and ethnic groups to examine differential effects on such groups. NIH guidelines stipulate that when proposing a Phase III clinical trial, evidence must be reviewed to establish whether or not there are potentially clinically important gender and minority based differences in the anticipated effects of the intervention. If previous studies support the existence of significant differences, the primary questions and design of the study must specifically accommodate this. For example, if men and women are thought to respond differently to an intervention, then the Phase III clinical trial must be designed to answer two separate primary questions, one for men, and the other for women. When prior studies support no significant differences for either gender or minorities with a given intervention, then gender and minority status will not be required as subject selection criteria, though the inclusion and analysis of both genders and minorities is strongly encouraged. When prior studies neither support nor negate significant differences, then the design of the Phase III clinical trial will be required to support sufficient representation of both genders and minorities to allow for valid analysis of the intervention effects across all groups. However, the trial will not be required to provide high statistical power for these comparisons.




EC -3