Improving consideration of sex and gender in clinical trials of cardiovascular disease

Principal Investigator: Ann Pederson

Co-Investigators: Stephanie Coen, Marion J. Doull, Janet E. Jull, Jennifer Petkovic, Lorri Puil, Vivien E. Runnels, Beverley J. Shea, Vivian A. Welch, Manosila Yoganathan

A substantial body of health research signals the importance of understanding how dynamics of sex -based biological characteristics and gender-based socio-cultural factors affect aspects of cardiovascular diseases (CVD. While sex- and gender-specific risk factors and barriers to treatment for heart disease are well documented, it is not yet routine for clinical trials and intervention studies to take sex and gender into account. Addressing sex and gender in clinical trials and intervention research is critical to enhancing the quality of evidence for clinical and policy decisions. A set of planning activities to support the development of a multi-year program of research proposes to identify and enhance methods to improve the consideration of sex and gender in clinical and intervention trials in relation to cardiovascular diseases: (1) conduct an on-line stakeholder consultation to assess awareness of sex/gender analysis policies and tools and gather input regarding integration of SGA into their work, and (2) hold a 2-day planning meeting to develop a research proposal for a project grant to improve sex/gender analysis in clinical trials and intervention studies. Outputs from our planning activities will include a proposal for a research grant, summary report for stakeholders, and an open-access manuscript reporting on our findings. The subsequent research proposal will contribute novel evaluative evidence of the influence of policy guidance on sex/gender analysis in clinical and intervention trials in Canada in relation to cardiovascular disease (particularly in women), as well as evidence on barriers to implementation and facilitators to improving the appropriate consideration of sex/gender.