A Feasibility Study: Building and Operating a Biospecimen Repository in South Africa for Storage and Redistribution of Specimens from Large Scale, Multicenter Clinical Trials
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2018-05
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Abstract
Current annual cost estimates for storage and redistribution of biological specimens collected for large scale, multicenter clinical trials in sub-Saharan Africa conducted by the HIV Vaccine Trials Network (HVTN) are expected to reach $13 million in the next 10 years, likely totaling in excess of $29 million over the life of active study protocols. While similar biorepository expenses are covered by the U.S. Federal government for domestic studies, international samples collected and stored abroad remain the responsibility of each grant. As U.S. Federal funding remains flat, HVTN awards are presented with a substantial burden. The objective of this Capstone project was to provide research results and analysis of constructing and operating an independent biorepository in the country of South Africa, compared to existing contracted repository services. To meet the objective and provide recommendations to the HVTN for future steps, a multi-step approach was taken including: 1) a literature review; 2) oral interviews with personnel involved in repository functions; 3) data collection to assist in estimating anticipated numbers of biological specimens for storage and project expenses; 4) the creation of a biorepository space concept; and 5) a cost analysis for one-time building and ongoing operating expenses of an independent repository. Calculated estimates of $6,349,746 for construction and $2,456,172 for annual operating expenses in the first year, increasing at a rate of 7% per year with fewer freezer purchases in out years, indicate a cost savings to the HVTN, with initial one-time building expenses being recouped by Year 4 of operations. Literature and expert interviews confirm that the construction and operations of an independent biorepository in South Africa is a complex multi-variable endeavor that ultimately has no perfect approach. The data collected and analyzed here seem to indicate that there would be significant financial savings, and may be a favorable option for further pursuit. However, embarking on this operation would be a large initial funding issue and complicated administrative and logistical undertaking, presenting risks to established partnerships and a liability for maintaining compliance with local, country-specific, U.S., and international regulations.
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feasibility study, repository, international research