There continues to be a significant lack of representation of women, minority and underserved populations in clinical trials. As a result, clinical practice and guidelines are applied to populations of individuals who were not represented.
Precia Group is about to change that.
- There is a biological difference between men and women but historically in research, an assumption was made that biological differences didn’t matter.
- It wasn’t until 1994 that the National Institutes of Health first established a policy that encouraged researchers to include women in clinical studies.
- Since that time, numerous legal and policy initiatives have been implemented to increase female representation. However, women, especially those from disadvantaged populations, are still routinely underrepresented in clinical trials because gender bias still exists.
Inclusion of Underrepresented Participants in Clinical Trials
1994 – NIH guidance issued: Inclusion of women in clinical trials
2018 – FDA guidance issued: Inclusion of pregnant women in clinical trials
2022 – National Academies Consensus Report published: Building Research Equity for Women & Underrepresented Groups
2022 – FDA draft guidelines issued: Improve enrollment of underrepresented populations in clinical trials