Does South Africa need a national clinical trials support unit?

BACKGROUND No national South African institution provides a coherent suite of support, available skills and training for clinicians wishing to conduct randomised controlled trials (RCTs) in the public sector. We report on a study to assess the need for establishing a national South African Clinical Trials Support Unit. OBJECTIVES To determine the need for additional training and support for conduct of RCTs within South African institutions; identify challenges facing institutions conducting RCTs; and provide recommendations for enhancing trial conduct within South African public institutions. DESIGN Key informant interviews of senior decision-makers at institutions with a stake in the South African public sector clinical trials research environment. RESULTS Trial conduct in South Africa faces many challenges, including lack of dedicated funding, the burden on clinical load, and lengthy approval processes. Strengths include the high burden of disease and the prevalence of treatment-naïve patients. Participants expressed a significant need for a national initiative to support and enhance the conduct of public sector RCTs. Research methods training and statistical support were viewed as key. There was a broad range of views regarding the structure and focus of such an initiative, but there was agreement that the national government should provide specific funding for this purpose. CONCLUSIONS Stakeholders generally support the establishment of a national clinical trials support initiative. Consideration must be given to the sustainability of such an initiative, in terms of funding, staffing, expected research outputs and permanence of location.