Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Speaker

Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC
Mount Sinai Endowed Professor of Cardiovascular Clinical Research and Outcomes
Professor of Medicine (Cardiology), and Population Health Science and Policy
Director, Interventional Cardiovascular Research and Clinical Trials
Director, Women’s Heart and Vascular Center at Mount Sinai Heart
Icahn School of Medicine at Mount Sinai 

Keywords

Cardiovascular Health, Interventional Cardiovascular Research, Diversity, Health Disparities

Key Points

  • There are important gender disparities in cardiovascular health. Globally cardiovascular disease (CVD) prevalence had decreased between 1990 and 2010, but it has slightly increased since 2010.
  • CVD is the leading cause of mortality in women. The median survival time after a first myocardial infarction (MI) for adults 45 years and older is 8.2 years for males and 5.5 years for females at age 45 years or older. Of those who have had a first MI, the percentage with a recurrent MI or fatal CHD within 5 years is 17% of males and 21% of females age 45 years or older. Hospital admissions with acute coronary syndrome in women younger than 55 years increased 21% in 1995-1999 and 31% in 2010-2014.
  • There are also ethnic and racial disparities. By 2045, more than 50% of the population in the U.S. is expected to be other than non-Hispanic white. It is important to note when you look at the ARIC surveillance data, there is consistently higher risk in black females and males across all ages.
  • Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low.
  • Diversity in clinical trials is important for generalizability of results, to provide equal opportunities, practice precision medicine, tailor practical guidelines, improve public health outcomes, detect potential differences in safety and efficacy, and to address health disparities.
  • There are several strategies that will help increase diversity in CVD trials. First, increasing diversity among trial participants must be a top priority in order to address health disparities and allow for optimal diagnosis and management of CVD in all.
  • Increasing diversity in trial leadership is one of the most important strategies to increase diversity among RCT participants.
  • Further efforts are urgently needed to increase diversity in the cardiology workforce, which will improve clinical trial diversity and cardiovascular health for all.
  • Approaches from the whole scientific community to tackle the inequality in workforce, trial leadership and trial participants have to be developed.

 

Discussion Themes

-What have been the challenges in developing and identifying people interested in working in clinical trials? Many high school and college students are moving away from the sciences. We have to change how we are practicing. The biggest barrier for CV medicine is the lack of women leaders in CV. Trainees don’t see a way forward. Work-life balance is a very important issue and will be for the next generation of women and men.

-Have you looked at the differential recruitment approaches between provider led and EHR-led approaches? Can we use blinded HER-led recruitment efforts to identify participants? This is a really important point because we know that providers have bias, and it is the providers who do not approach women for enrollment.

What about women who are excluded because they are pregnant or planning to be pregnant? It is an excellent question. With the current ability to become pregnant this can affect women up to the age of 50. These are really excluding many women on the basis of this exclusion. We need to think about removing some of this and evaluate.

Tags

#pctGR, @Collaboratory1