Biomarkers and Adherence
One of CONRAD’s strengths is the capability to drive a novel biomarker from discovery to clinical validation. Biomarkers are biochemical substances that can be used to measure the progress of disease or the effects of treatment. In vaginal product research, biomarkers could provide early information about the safety and likely efficacy of both contraceptive and microbicide products, facilitating study design of large-scale clinical trials. In addition, biomarkers of sexual behavior and study product use could help with interpretation of study results. As examples, CONRAD has developed new biomarkers of cervicovaginal inflammation, indicating safety of candidate vaginal products, new biomarkers of vaginal exposure to semen, indicating unprotected intercourse, and new biomarkers to detect product use. In an effort to improve product usage and efficacy, CONRAD pioneered the development of novel markers of adherence.
STUDIES
D11-115 – Prospective Evaluation of the Impact of Bacterial Vaginosis and its Treatment on Mucosal Susceptibility to HIV-1 Infection and Endpoints of CervicoVaginal Safety
(Clinicaltrials.gov Identifier: NCT01347632)
D11-119 – Identification of novel biomarkers of cervicovaginal mucosal inflammation
(Clinicaltrials.gov Identifier: NCT01593124)
D13-125 - Comparison of Objective Biomarkers of Protocol Compliance and Product Adherence with Classic Markers of Compliance and Adherence
(Clinicaltrials.gov Identifier: NCT01804023)