NIH and NIAID are strongly committed to researching diseases of global health importance. Many infectious diseases (e.g. malaria, tuberculosis, diarrhea, etc.) cause major health problems in tropical regions, and children are especially at risk. Also, some of these diseases formerly viewed as strictly tropical have """"""""emerged"""""""" globally. NIAID has responded by expanding its mission and commitment on these diseases, their prevention and treatment. NIAID must use tropical sites while complying with current DHHS guidelines and domestic scientific, ethical and fiscal standards. It already supports projects at nearly 30 developing-world sites, but most need enhancements of infrastructure and skills in order to properly conduct, manage and analyze their research. This Contractor has key roles in assuring sites' readiness, i.e.: 1) assess sites' preparedness to meet current U.S. and international human subjects and regulatory standards; 2) assess other site capacities, such as communications, computer systems and the ability to perform data entry and data management; and 3) provide guidance, training and logistical assistance needed to meet the standards and goals. Additionally, the Contractor directly provides support services when needed, e.g. coordinating development of protocols and case report forms, coordinating groups' conference calls and meetings, developing statistical analysis plans and performing statistical analysis. Its role is supportive and developmental to NIAID and to its clinical investigators, enabling more successful research on infectious disease questions important to all of them. It assists with a variety of studies from epidemiological surveys to Phase III clinical trials, not by supplanting site activities but by supplementing functions competently performed by clinical sites.
| Herrera, Sócrates; Fernández, Olga Lucía; Vera, Omaira et al. (2011) Phase I safety and immunogenicity trial of Plasmodium vivax CS derived long synthetic peptides adjuvanted with montanide ISA 720 or montanide ISA 51. Am J Trop Med Hyg 84:12-20 |
| Chen-Mok, M; VanRaden, M J; Higgs, E S et al. (2006) Experiences and challenges in data monitoring for clinical trials within an international tropical disease research network. Clin Trials 3:469-77 |
| Herrera, Socrates; Bonelo, Anilza; Perlaza, Blanca Liliana et al. (2005) Safety and elicitation of humoral and cellular responses in colombian malaria-naive volunteers by a Plasmodium vivax circumsporozoite protein-derived synthetic vaccine. Am J Trop Med Hyg 73:3-9 |
| Arevalo-Herrera, Myriam; Castellanos, Angelica; Yazdani, Syed S et al. (2005) Immunogenicity and protective efficacy of recombinant vaccine based on the receptor-binding domain of the Plasmodium vivax Duffy binding protein in Aotus monkeys. Am J Trop Med Hyg 73:25-31 |
