Diversity in Research and the All of Us Research Program

Diversity in Research and the <em>All of Us</em> Research Program Posted By:
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I have been working in the PA field for well over 18 years and have always thrived on knowing that I am treating my patients with evidence-based medicine. However, during a recent educational talk about cardiovascular health, it was brought to my attention that women and minorities have historically been excluded from clinical trials. In 1977, the FDA barred women of child-bearing age from participating in most early-phase clinical research. Over time, there was a shift in this exclusion, and in 1987, the FDA required that both sexes of animals be included in pre-clinical drug safety studies for products being targeted to both males and females. Finally, in 1993, there was a significant change in clinical trial representation: A bipartisan group of legislators, urged by patients, medical providers, and policy advocates, passed the NIH Revitalization Act. This mandated the inclusion of women and minorities in all research sponsored by the NIH; the FDA then created a guideline for the study and evaluation of gender differences in clinical evaluation of drugs.

While this change has led to more inclusion of women and minorities in clinical trials, basic research is usually not designed to study the impact of sex on disease. Women are still often underrepresented, and impact of sex differences discovered in research is often ignored. Therefore, outcome measures are not always well-analyzed or reported by sex. This is a critical oversight, as sex differences affect the pharmacokinetics of many drugs, with females and males demonstrating different drug absorption, distribution, metabolism, and excretion rates.

To help raise awareness about the importance of including diversity—including sexual, gender, and minority representation—in research, the AAPA and the PA Foundation are partnering with the NIH in the All of Us Research Program. This program collects data from traditionally underrepresented individuals for use in future research. The goal is to engage researchers from all backgrounds to utilize the data from the All of Us resources to advance precision medicine.

As a provider who feels strongly about diminishing health disparities and inequities within the Latinx and women communities, I wanted to share information about the importance of disseminating this information to fellow providers in hopes that you will review the information and then make a personal decision to share it with your colleagues and patients. As a Latina, I hope that this program will lead to greater inclusion in clinical trials and help to further treatment options for patients of all genders and races.

Here is the direct link to the All of Us NIH program.

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Filed under: Women's Health , Health Policy and Trends , Miscellaneous

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