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Abstract ISSUES: A major challenge to establishing the efficacy of a candidate microbicide is managing the significant cost implications (e.g., staffing, operating expenses, and capital costs) of a Phase 3 clinical trial. Addressing this challenge is complex for both sponsors and clinical trial sites. Having set up and managed a clinical trial site for the Phase 3 Carraguard® trial, sponsored by the Population Council, and with the fiscal experience gained over 7 years in microbicide research, the authors wish to share their experiences with the field and help to inform future trial sites of the financial management challenges that may be faced. DESCRIPTION: The budget is a tool used to balance the risk of underbudgeting and overpricing. A budget model is provided taking into account the development of facilities, purchasing of equipment, staff requirements, and annual running costs. In order to assess budgetary requirements the following issues are addressed: dealing with exchange rate differences, inflation rates, and accurately predicting specific needs for the year ahead. Areas where the authors overbudgeted and underbudgeted are identified and analyzed and potential pitfalls are described. Experience shows that in the first year of a trial, there is a greater risk of over/underbudgeting in line items such as staffing and operating expenses as the trial is in its initial stage. During the course of the trial some aspects of budgeting become more predictable, but challenges still remain. Some of the specific challenges are described, such as the negotiation of budgetary and purchasing practices across institutions (e.g., Population Council and the University of Cape Town), donor policies for accountability that can be counterproductive, and anticipating ongoing study requirements. CONCLUSION: The challenges, experiences, and lessons learned will inform the field by providing insight into the management of funding a Phase 3 clinical trial site generally and the specific challenges faced in practical terms by the site. Poster Session
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