The South Africa Medical Research Council convened a summit to discuss issues relating to Standard of Care in clinical trials, both of treatment and prevention. Policymakers, regulators, ethicists, experts in the law (as it pertains to medical research) and researchers involved in both HIV and Cancer presented a framework within which Standard of Care principles could be articulated. How and when to include new modalities of treatment and prevention into existing essential medical guidelines was the emphasis of the Summit. Participants involved in the execution of care and the scale up of new interventions, in particular, the roll out of Pre-exposure Prophylaxis, presented the opportunities and challenges when it comes to scaling up interventions, and their experience with demonstration projects of PrEP. Advocates and community members propagated the need to make interventions that could avert HIV infection available as soon as possible. Experts in evidence-based guideline development discussed the nuances in evaluating evidence for policy and the mechanisms for getting medicines on the essential medicine list in South Africa. Given the variability in efficacy in PrEP amongst different populations, scientists and statisticians, discussed the various biological, virological and immunological reasons for this heterogeneity. Input was given as to the impact of introducing PrEP in other HIV prevention trials, and the considerations for the design of both ARV based and non-ARV based HIV prevention trials.
Executive Summary of the Summit on the Standard of Care in Clinical Trials in Low-Middle Income Settings
Thursday, November 30, 2017 - 14:30