Counterfactual estimation of efficacy against placebo for novel PrEP agents using external trial data: example of injectable cabotegravir and oral PrEP in women.
Deborah DonnellFei GaoJames P HughesBrett HanscomLawrence CoreyMyron S CohenSrilatha EdupugantiNyaradzo M MgodiHelen ReesJared M BaetenGlenda GrayLinda Gail BekkerMina C HosseinipourSinéad Delany-MoretlwePublished in: Journal of the International AIDS Society (2023)
Counterfactual placebo rates of HIV acquisition derived from external trial data in similar locations and time can be used to support estimates of placebo-based efficacy of a novel HIV prevention agent. External trial data must be standardized to be representative of the clinical trial cohort testing the novel HIV prevention agent, accounting for confounders.
Keyphrases
- phase iii
- clinical trial
- phase ii
- open label
- double blind
- study protocol
- electronic health record
- men who have sex with men
- big data
- hiv testing
- placebo controlled
- randomized controlled trial
- human immunodeficiency virus
- antiretroviral therapy
- metabolic syndrome
- polycystic ovary syndrome
- hiv aids
- pregnant women
- data analysis
- insulin resistance
- pregnancy outcomes
- hyaluronic acid