Byramee Jeejeebhoy Medical College (BJMC), Pune, India: Clinical Trials Unit
Start Date: 09/20/2007
End Date: 01/31/2014
The Indo-US collaborative research group, at the Byramjee Jeejeebhoy Medical College (BJMC) in Pune, India, is currently conducting the only NIH-sponsored; Phase III randomized clinical trial for prevention of mother-to-child HIV transmission (MTCT) in India. The study will provide a Clinical Trials Unit (CTU) with a single Clinical Research Site (CRS) that will build upon the success of existing leadership, organization, clinical trials management procedures, as well as experienced investigators and staff. The CTU will participate in trials that will address two research priority areas: 1) Prevention of MTCT and 2) Optimization of Clinical Management of HIV-infected Children. Johns Hopkins University (JHU) will support the CTU leadership, administration, community activities and a single CRS in Pune, through two subcontracts (BJMC and ED SEARCH). BJMC will provide scientific and administrative leadership to the CTU, as well as clinical/laboratory infrastructure and clinical care support for the CRS. BJMC will also utilize the help of the National AIDS Research Institute for specialized laboratory support. ED SEARCH, a registered, Indian, non-profit Trust will provide scientific and administrative leadership, as well as day-to-day management of the CRS, regulatory requirements and good clinical practices. ED SEARCH will also manage support of the Community Advisory Board, as well as the trial recruitment program in 21 community-based clinics run by the Pune Municipal Corporation and the Pimpri Chinchwad Municipal Corporation.