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Challenges in implementing and managing clinical trials in developing countries: lessons learned by the national cancer institute's (NCI) AIDS malignancy consortium (AMC)



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

SCT Annual Meeting

Liverpool, UK


Trial Management & Research Coordination

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 expanded operations internationally and opened 4 sites located in sub-Saharan African countries with a high prevalence of HIV. The goal of this expansion was to build a cancer clinical trials network in sub-Saharan Africa (SSA) that was capable of conducting contextually appropriate therapeutic and prevention trials in a variety of HIV-associated cancers and contributing to the AMC’s scientific agenda. The AMC Operations and Data Management Center (AMC ODMC) provides data management and site management support for both domestic and international AMC trials. Over the past 7 years, the AMC ODMC has supported 3 trials in SSA and identified a number challenges to trial implementation and activation. The key challenges the AMC ODMC faced in implementing these trials included identifying research priorities, developing multicenter trials that are appropriate across a diverse group of trials sites, conducting clinical research trials within the public healthcare system, inadequate infrastructure, availability of qualified staff, and identifying and addressing site logistical barriers such as drug and supply needs. Furthermore, the importance of supporting capacity-building activities such as training of health care staff at the research sites is part of the AMC’s mandate in SSA and requires additional site management support. Currently, there are 2 open trials and 4 trials in expected to open within the next 18 months across 7 sites in Sub-Saharan Africa, including sites in Zimbabwe, Uganda, Kenya, Malawi, Tanzania and South Africa. Site management lessons learned from these trials may be applicable to other international trials and particularly relevant to those designed for implementation in developing countries where both human and material resources may be limited.

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