Developing a Comprehensive Site Selection Process for a Cancer Network in a Resource-Limited Settings in Sub-Saharan Africa Meg Wirth AMC Operations & Data Management Center The Emmes Corporation

AIDS Malignancy Consortium (AMC) NCI-funded, multicenter, clinical trials group established in 1995 “The mission of the AMC is to investigate new treatment and prevention interventions for malignancies in people living with HIV both in the USA and internationally and to study the pathobiology of these tumors in the context of clinical trials” The AIDS Malignancy Consortium is funded by the U.S. National Cancer Institute. The mission of the group is to investigate new treatment and prevention interventions for malignancies in people living with HIV and to study the pathobiology of these tumors in the context of clinical trials. The AMC was established as a US clinical trials group, but was asked by NCI, who recognizes the importance of cancer treatment, diagnostics, and prevention on a global scale, to expand operations internationally with a focus on low and middle income countries with a significant prevalence of HIV.

Goal of the AMC’s International Expansion To design and implement therapeutic and prevention protocols that are suitable for conduct in resource-limited environments by engaging a core group of clinical sites capable of conducting clinical trials in a number of disease areas. The goal of the international expansion was to…….. A small committee was established within the AMC to develop a strategy to engage international sites. This committee was comprised of AMC investigators with international clinical trials experience and those with an interest in conducting studies in resource limited settings.

Site selection strategy Plan Identify potential sites Two tiered site selection strategy: 1) engage sites/general info gathering 2) collect data and conduct onsite visits Tier 1 General and disease specific survey Score responses Tier 2 Open a retrospective chart review study to collect information on HIV-positive patients with AIDS-defining malignancies: Kaposi Sarcoma, non-Hodgkin lymphoma, and cervical cancer Site visit and data audit Select sites The AMC developed a tiered strategy to select international sites. The first phase of site selection sought to identify sites with an interest in collaborating with the AMC and to gather basic information. In the second phase, a subset of the sites would be invited to participate in a protocol where information regarding patient characteristics were collected. All clinical sites participating in the 2nd tier of selection would have an onsite visit by members of the AMC and an audit of the protocol data.

Tier 1: getting to know you 2008 preliminary survey distributed Sent to 21 sites (14 Sub-Saharan Africa, 3 India, 4 South America) General survey (site information, available support for HIV-related care, available ARVs, prior clinical trials experience) Disease specific survey (interest in clinical trials, patient volume, diagnostic workup, standards of care for treatment, imaging facilities) Kaposi sarcoma (KS) Non-Hodgkin lymphoma (NHL) Cervical cancer (CaCX) Surveys were scored and 14 sites were invited to participate in a survey study 10 SSA, 2 India, 2 South America In 2008, we contacted 21 sites in SSA, India, and South America to gauge their interest in collaborating with the AMC. The sites selected were not random – a member of the site staff had pre-existing relationships with an AMC investigators or the site was recommended to the group. Interested sites were requested to complete a two part survey. The first part was a general site survey, which sought to gather information regarding the site’s available resources, capabilities, and active collaborations with other organizations. The second part of the survey contained disease-specific questions focusing on Kaposi’s sarcoma, non-Hodgkin’s lymphoma, and cervical cancer. Data was collected on case load/patient volumes, methods of treatment and care for the specific AIDS-related malignancy at the site. The sites were instructed to complete and return the general questionnaire and disease specific questionnaires for any disease area where the site had an interest in conducting future studies. The responses from each site were reviewed and scored by the selection committee. The top scoring sites were invited to participate in the retrospective chart review study

Tier 2: AMC-S002 & site visits AMC-S002: A Study of Patients in Resource- Limited Areas with Cancer who also have HIV Opened at 13 sites in 2009-2010 458 participants enrolled (198 KS, 121 NHL, 132 CACX) Decision made to select SSA sites only 9 sites visited (Nov 2009 & May-Sept 2010) In 2009, the AMC activated S002 – a study of patients in resource-limited areas with cancer who also have HIV. This study was opened at 13 clinical sites and 458 participants were enrolled in 3 disease areas – KS, NHL, and CACX. This study had two objectives: 1) to collect basic information about the treatment of KS, NHL, and CACX at the sites and 2) to assess whether the site could open a study and enroll participants with limited support. During the site selection process the AMC leadership recognized the complexities and costs associated with conducting studies in a resource-limited setting so the decision was made to focus on SSA due to the high number of HIV+ peoples living there.

Tier 2: Site visits AMC-S002 audit Site tour Data audit: 100% verification of up to 20 participants in each disease area Regulatory audit Site tour Site organization & staff Facilities (oncology wards/infusion centers, pharmacy, laboratory, imaging, etc.) Site infrastructure (e.g. internet access, computers, storage space, etc.) Clinical trials infrastructure

Site Selection 4 sites with highest scores selected Audit report and site visit report prepared for each site Summary sheets used for comparison Site selection committee scores each site in the following categories: Investigators (e.g. clinical trials experience and clinical expertise) Environment (e.g. pathology, radiology, laboratory) Infrastructure to support AMC trials Patient volumes Organizational capacity 4 sites with highest scores selected

Lessons Learned Onsite visits are essential Assess site suitability Standardized site visit worksheets Targeted questions Aids with comparison Formal application process Targeted information gathering