MULTIPLE STUDY DATA COORDINATING CENTERS FOR DIVISION OF INTRAMURAL POPULATION HEALTH RESEARCH (DIPHR)

Kai Research, Inc, Rockville MD

Investigators

Abstract

The Division of Intramural Population Health Research (DIPHR) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has the need to establish a Data Coordinating Center (DCC) IDIQ contract to support the original research projects conducted by its investigators. The Division encompasses three branches: 1) Biostatistics & Bioinformatics; 2) Epidemiology, and 3) Social and Behavioral Sciences Branch [https://www.nichd.nih.gov/about/org/diphr/pages/about.aspx]. Central to the Division's mission is to design, implement, and conduct epidemiologic, biobehavioral and biostatistical research. This includes reproductive, perinatal and pediatric epidemiologic research, as well as research addressing gravid women, and child and adolescent health and health behaviors. Original biostatistical and bioinformatics methodology is developed based on analytic problems encountered in the design and/or conduct of the epidemiologic or biobehavioral research. As an intramural entity, the Division is charged with research aimed at filling critical data gaps within its mission by utilizing state-of-the-art methodologies and technologies. In addition, DIPHR investigators are charged with the timely communication of research findings to professional and lay audiences. DIPHR typically implements eight to ten concurrent, large (>500 participants), longitudinal, population-based (e.g. observational prospective cohort and randomized clinical trials) studies with a DCC through the task order mechanism on the Government fiscal year calendar. Each major study lasts from two to five years; smaller studies of one to two years that may require support, mostly building on or expanding earlier work, may also be undertaken in the course of any year should funds permit. DIPHR studies involve epidemiologic and biobehavioral research within the following broad domains and as described below: etiologic research; clinical prediction; clinical efficacy or intervention trials; and behavioral intervention trials. Studies often involve collection and/or laboratory analysis of biospecimens, including specimens from diverse biological media, such as blood, serum, urine, placental tissue, fat tissue, hair samples, and saliva, among others. The Epidemiology and Social and Behavioral Sciences Branches typically conduct population-based research that utilizes observational, prospective cohort studies or randomized controlled trials (RCTs). The sampling frameworks for such studies may be from targeted clinics, research sites or geographic areas, and may include convenience and population-based sampling. Sampling may be on the individual, population or group (e.g., family) level. For example, investigators may use a couple-dependent approach to fertility, a family approach for follow-up of children born after maternal gravid complications, a classroom-based approach for surveying children, or multi-generational approaches to the genetics of diseases. Hence, the ability of the Contractor to support individual or higher order units of analysis is essential. Unique requirements of RCTs include the capacity of the contractor to support all trial activities, including, for example, randomization, outcome tracking, compliance assessment, and independent monitoring by a Data Safety Monitoring Board (DSMB). Smaller studies in scope and commitment, such as pilot studies or add-ons to an existing project, are also likely and will arise on an ad hoc basis, so that flexibility in overall capability is required. DIPHR research studies routinely collect a range of data types including self-report questionnaires (particularly during critical or sensitive windows within human reproduction and development), laboratory behavioral assessments, biospecimens, medical records, electronic data (e.g., using fertility monitors, peak flow meters or other PDA-type devices), and, increasingly, digital data (e.g., x-rays, MRIs, ultrasound images, operative photographs, video from camera-outfitted motor vehicles) and wearable devices (e.g., accelerometers).