Overview and experience of the YODA Project with clinical trial data sharing after 5 years.

The Yale University Open Data Access (YODA) Project has facilitated access to clinical trial data since 2013. The purpose of this article is to provide an overview of the Project, describe key decisions that were made when establishing data sharing policies, and suggest how our experience and the experiences of our first two data generator partners, Medtronic, Inc. and Johnson & Johnson, can be used to enhance other ongoing or future initiatives.

Outcomes of infants born to women infected with hepatitis B.

BACKGROUND AND OBJECTIVES: Perinatal exposure is an important mode of hepatitis B virus (HBV) transmission, resulting in chronic disease in ∼ 90% of infected infants. Immunoprophylaxis recommended for infants born to hepatitis B surface antigen-positive mothers reduces up to 95% of perinatal HBV infections. We sought to identify factors associated with perinatal HBV transmission. METHODS: We analyzed prospectively collected data from 5 of 64 US-funded Perinatal Hepatitis B Prevention Programs during 2007-2013. We examined effects of maternal demographic and laboratory results, infant gestational age and birth weight, and immunoprophylactic management on perinatal HBV infection. RESULTS: Data from 17,951 mother-infant pairs were analyzed. Among 9252 (51.5%) infants for whom hepatitis B surface antigen testing results were available, 100 (1.1%) acquired perinatal HBV infection. Both hepatitis B (HepB) vaccine and hepatitis B immune globulin were administered within 12 hours of birth for 10,760 (94.9%) of 11,335 infants with information. Perinatal HBV infection was associated with younger maternal age (P = .01), Asian/Pacific Islander race (P < .01), maternal hepatitis B e-antigen positivity (P < .01), maternal antibody to hepatitis B e-antigen negativity (P < .01), maternal viral load ≥ 2000 IU/mL (P = .04), and infant receipt of <3 HepB vaccine doses (P = .01). Four infants born to 429 mothers with viral load testing were infected; all 4 were born to mothers with viral loads in the ninth or tenth decile. CONCLUSIONS: Perinatal HBV infection occurred among 1% of infants, most of whom received recommended immunoprophylaxis. Infants at greatest risk of infection were those born to women who were younger, hepatitis B e-antigen positive, or who had a high viral load or those infants who received <3 HepB vaccine doses.