Heart Rhythm Society Volunteers Participate in FDA Workshop
On Monday, June 2, 2008, Sana Al-Khatib MD, FHRS and Mina Chung MD, FHRS served as panelists on behalf of the Society at a workshop sponsored by the U.S. Food & Drug Administration (FDA) Office of Women’s Health and the Center for Devices and Radiological Health.
“Exploration of Public Policy Development Regarding the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Products” focused on two areas: exploring strategies for improving the proportion of women in CV trials, and to develop recommendations for the analysis and reporting of safety and effectiveness by sex.
The meeting sought to achieve the following:
- Review the current status of inclusion of women and other underrepresented demographic groups in clinical CV trials
- Describe parameters of appropriate number of women and other underrepresented demographic groups commensurate with the CV disease prevalence
- Examine the barriers encountered in enrollment of women and other underrepresented demographic groups in clinical CV trials
- Develop recommendations for prospectively planned inclusion of women and other underrepresented demographic groups in clinical CV trials
- Review the current status of analysis and reporting of sex differences in clinical CV trials
- Discuss methods for a priori decision for statistical analysis of important demographic subgroups (sex, race, age)
- Develop recommendations for standard statistical analysis and data presentation format for demographic subgroup analyses
- Discuss post-market considerations for targeted study in women
The FDA will post a summary of the workshop and next steps online. Another possibility would be reconvening of the workshop for development of an action agenda by year-end. Learn more by visiting the FDA website.
The Heart Rhythm Society will plan to remain actively involved in these activities with the goal of promoting the need for more equal female representation in CV clinical trials.
