Voices of those recruiting: A qualitative study on barriers and enablers to women's participation in cardiovascular trials

Abstract

Background and aims Cardiovascular disease is the leading cause of death among women, yet women remain underrepresented in cardiovascular clinical trials. This qualitative study explored perspectives of research personnel on barriers and facilitators to female trial participation. Methods Semi-structured interviews were conducted between June and September 2024 across cardiology research sites in the Netherlands. Twenty research professionals (70% women), including nurses, trial coordinators, and cardiologists/principal investigators, were interviewed using a predefined topic guide. Interviews were transcribed verbatim and analyzed using thematic content analysis. Results Data saturation, defined as the point at which no new themes emerged from additional interviews, was reached after 20 interviews. Three main themes emerged: (1) the importance of diversity in trials, (2) barriers to participation, and (3) facilitators for participation. Although diversity was widely recognized as essential, it was also perceived as challenging to achieve. Key barriers to women's participation included (1) distrust in research, (2) fear of medication side effects, (3) not meeting inclusion criteria, (4) and caregiving responsibilities or limited time. Mentioned facilitators were grouped into two categories: (1) manner of approach, emphasizing tailored and patient-centered recruitment strategies, and (2) study design adjustments, including fixed ratios of females, female-only trials, and improved logistical flexibility. Conclusions Research personnel distinguished between women unable to participate due to external constraints and those unwilling due to personal beliefs. Addressing trust, perceived risks, and logistical challenges through tailored recruitment and adapted trial designs may enhance women's participation in cardiovascular clinical trials.