Women participants in cardio-renal-metabolism trials: Actionable steps to drive lasting change
Join us at our joint session with CVCT discussing the role of women in clinical trials, and how can create long-term, sustainable change.
Date and time: Saturday December 2, 8:30am – 10:30am
Location: Global Cardiovascular Clinical Trialists Forum, The National Press Club 529 14th St NW, Washington, DC 20045
Room: Fourth Estate
Agenda
Chairpersons: Mary N. Walsh (St Vincent, IN, USA), Cindy Westerhout (Edmonton, CAN)
| Women participation in drug/device clinical trials |
Roxana Mehran (New York, NY, USA) |
| Exclusion by design: the role of eligibility criteria in under-representation of women in clinical trials |
Harriette Van Spall (Hamilton, Canada) |
| Biological plausibility of sex differences in CV trials. Is a difference expected? |
Angela Maas (Nijmegen, NED) |
| Meta-analysis of sex-based subgroup analyses in CV trials. |
Vijay Kunadian (Newcastle upon Tyne, UK) |
| Differences between men and women. When, and how to demonstrate? How and when explore differences using subgroup analysis? |
Cindy Westerhout (Edmonton, CAN) |
| What sex related difference is clinically meaningful? Dosing, efficacy or safety differences? |
Orly Vardeny ( Minneapolis, MN, USA) |
| Are Sex – gender differences accounted for in regulatory approval? |
Terri Cornelison (FDA, USA) |
| NIH viewpoint |
Lisa Begg (NIH, Office of Research on Women’s Health, USA) |
| Patient viewpoint |
Lisa Salberg (HCMA, USA) |
