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Developing a comprehensive site selection process for a cancer network in a resource-limited settings in sub-Saharan Africa



Wirth, Megan; Blumberg, Dikla; Mosby-Griffin, Kimberly; Vena, Don

SCT Annual Meeting

Liverpool, UK


Trial Management & Research Coordination

Introduction: To successfully execute clinical trials the study operations team must have an appreciation of the capabilities of the clinical sites. This is particularly vital in developing countries where necessary infrastructure, availability of qualified staff and proper facilities are often scarcer than in wealthier nations. The AIDS Malignancy Consortium (AMC) is a National Cancer Institute supported multicenter clinical trials group founded in 1995 to support innovative trials for AIDS-related cancers. In 2010 the AMC was tasked with expanding operations internationally in sub-Saharan African countries with a high prevalence of HIV, with the goal of identifying and engaging a core group clinical sites that were capable of conducting contextually appropriate therapeutic and prevention trials in a variety of HIV-associated cancers and contributing to the AMC’s scientific agenda. Methods: In response to this new initiative, the AMC developed a two-tiered strategy to select international sites. This began by soliciting applications from 14 sites in which a member of the site staff had a pre-existing relationship with an AMC investigator, and systematically gathering written information about their resources, clinical research experience and active collaborations with other clinical trials organizations. After review of these data, the nine top-ranked sites participated in a structured data collection exercise that involved collection of disease-specific patient information about three AIDS-related cancers, auditing that data, and conducting site visits. Each site visit team included an oncologist and a representative from the AMC Operations and Data Management Center (ODMC) and evaluators filled out a site visit worksheet at the end of each visit. Results: The information gathered from the sites provided insight into the identification, diagnosis, and treatment of patients at each of the sites. However, it was the on-site visits that proved most valuable in assessing suitability for participation in AMC trials. Based on the site visit evaluations the four top sites (in Zimbabwe, Uganda, Kenya, and South Africa) were selected for participation. Lessons learned from the implementation of the process allowed the ODMC to improve site selection methods by standardizing the site visit worksheets, and asking more targeted questions that better identified particular issues that were critical to study conduct. These changes streamlined the process and allowed for better comparison of the sites in the next round of site selection that occurred in 2014-5, during which three additional sites were selected. Conclusions: The AMC has developed a detailed and methodical process for selecting international sites that have the clinical research infrastructure, data management operations and the human and material resource capacity required to successfully participate in clinical trials in HIV-associated malignancies. In our experience, the most essential and valuable part of that process is the on-site visits, which have been successful in vetting research sites that would be able to provide high quality data and contribute to AMC’s mission of investigating new treatment and prevention interventions of malignancies in people living with HIV both in the USA and internationally. Strategies for maximizing the value of these visits and collection of material from the visits will be discussed.

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