Women in Clinical Trials and Race/ Ethnicity Data

FDA Guidances and Regulations:

Women in Clinical Trials and Race/ Ethnicity Data

Check the links to view FDA Center for Drug Evaluation and Research (CDER) guidances on gender and race/ethnicity of patients in clinical trials and regulations detailing sponsor requirements for clinical trials data submission.

Guidance Documents

▪ Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs: This guidance outlines FDA's expectations regarding inclusion of both genders in drug development.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072044.pdf

▪ Collection of Race and Ethnicity Data in Clinical Trials: This guidance recommends using a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071596.pdf

Regulations

▪ Investigational New Drug Applications (IND) and New Drug Application (NDA) regulations (21 CFR 312.33 and 21 CFR 314.50): These regulations require that NDAs contain information on clinical trial participation as well as analysis of safety and efficacy broken down for sex, age, and racial subgroups, and required the IND annual reports to tabulate the number of participants enrolled according to sex, age, and racial subgroups.

▪ The Amendment to Clinical Hold Regulations (21 CFR 312.42): These regulations allowed FDA to stop IND studies for treatment of life-threatening diseases if women or men were excluded primarily due to their reproductive potential.

ucm072044.pdf (Objeto application/pdf)