A bit of history
What does FDORA stand for?
Food and Drug Omnibus Reform Act (2022)
A 2022 analysis of clinical trials with over 300,000 participants found that, on average, only ____% of participants were female
41.2%
First African American woman physician; treated underserved women and children
Rebecca Lee Crumpler, M.D.
What species of animal was the subject of neurological research in the Grey's Anatomy clip we showed at the beginning of class?
Mice
What drug, widely used for the treatment of nausea in pregnant women in the 1950s, caused severe birth defects due to outdated testing practices
Thalidomide
Black/African American women make up approximately _______% of the United States population
14% (approximately)
This Nobel-winning biochemist developed key drugs for leukemia, malaria, and more
Gertrude B. Elion, Ph.D.
This iconic doll manufactured by Mattell Inc. has more diversity in skin color and body shape than early clinical trials had in participants
Barbie
A 1977 ________ Guideline banned pregnant women and most women of reproductive age from early-phase trials after the thalidomide tragedy.
FDA Guideline
In what year was the NIH Revitalization Act passed?
1993
Lead scientist behind the Moderna COVID-19 vaccine; advancing viral immunology during a global pandemic
Kizzmekia Corbett, M.D.
Symptoms like jaw pain, cold sweats, or lightheadedness may signal this condition in women, but are often overlooked due to lack of representation in research (among other factors)
Myocardial Infarction (MI) or Heart Attack
True or False: the NIH Revitalization Act requires the inclusion of women and minorities in some, but not all, NIH-funded clinical research
FALSE
The NIH Revitalization Act requires the inclusion of women and minorities in ALL NIH-funded clinical research
In what phase does a clinical trial compare the new treatment to existing treatment(s)?
Phase III
Pediatric cardiology pioneer; co-developed the Blalock-Taussig shunt for infants with heart defects
Helen Brooke Taussig, M.D.
What is the name of the administrative committee that reviews human subjects research to ensure that the research is ethical and complies with regulations?