This Core Central Laboratory and Data Coordinating Unit, will function as the clinical laboratory for Research Projects 1, 2 and 3, perform hemoglobin phenotyping, and provide clinical and basic science investigators with epidemiological and statistical consultation for all phases of the proposed research. The Core will be responsible for biochemical determinations on patient samples with a rigorous program of quality control. The hemoglobin phenotype may be an important determinant of (i) the susceptibility of an individual patient to infection with P. phenotype may be an important determinant of (i) the susceptibility of an individual patient to infection with P. falciparum and the risk of complication and (ii) the sensitivity of the intraerythrocytic parasite to some types of antimalarial chemotherapy. As a result, determination of the hemoglobin phenotypic is of critical importance for the evaluation of the clinical response to therapy in the clinical studies of Project 1, for the assessment of the immunological results in Project 2, and for the interpretation of the results of studies in vitro in Project 3. In addition, the Core unit will assist with procedures for participant recruitment, safety monitoring, quality control, data management, statistical analysis, and preparation of interim and final reports. The Core will be responsible for frequent, regular review of the quality of clinical and biologic sample data to be recorded at the study sites. Continuous monitoring of study questionnaires and data will be provided. The Core will serve as a data-coordinating center for Projects 1, 2, and 3. Data-base management will be provided for basic demographic, epidemiologic, clinical, and outcome data. The Core will assist in data analysis and interpretation of results. The specific objectives of the Core are:
Aim 1 : Serve as the clinical chemistry laboratory for Research Projects 1, 2 and 3.
Aim 2 : Provide characterization of hemoglobin phenotype for Research Projects 1, 2 and 3.
Aim 3 : Provide clinical and basic science investigators with epidemiological and statistical services. The services provided by the Core will be critical to the success of Projects 1, 2 and 3 and will facilitate the overall goal of clarifying the pathophysiology and therapy of malarial anemia.
