Inclusion of pregnant women in antiretroviral drug research: what is needed to move forwards?
Lee FairlieCatriona WaittShahin LockmanMichelle MoorhouseElaine J AbramsPolly ClaydenMarta BoffitoSaye KhooHelen ReesAmandine CournilWillem Francois VenterCelicia SerenataMatthew ChersichPublished in: Journal of the International AIDS Society (2020)
A formalized step-wise approach to including pregnant women in antiretroviral drug research should become the new norm. Systematic implementation of this approach would yield more timely and higher quality pregnancy dosing, safety and efficacy data. Through more vigorous action, regulatory bodies could responsibly overcome reluctance to include pregnant women in drug trials. Funders, researchers and programme implementers need to be galvanized to progressively include pregnant women in research - the use of newer, more effective drugs in women is at stake (349).
Keyphrases
- pregnant women
- pregnancy outcomes
- hiv infected
- human immunodeficiency virus
- hiv aids
- healthcare
- hiv positive
- primary care
- drug induced
- adverse drug
- type diabetes
- study protocol
- electronic health record
- metabolic syndrome
- emergency department
- preterm birth
- hepatitis c virus
- randomized controlled trial
- machine learning