Session 3: Future efficacy trial design approaches
The third session of the virtual workshop aims to reflect on novel scientific approaches for establishing efficacy of new biologics, community involvement and meaningful participation in trial design and regulatory approval. This session is supported by online presentations and three panel discussions.
Panel discussion 3A - Novel scientific approaches for establishing efficacy of new biologics
Panel discussion 3B - Community engagement and involvement in hiv vaccine prevention clinical research
PrEPVacc trial statistical analysis plan (S3-01), Sheila Kansiime, PhD, LSHTM, Medical Research Council / Uganda Virus Research Institute, Uganda
A Bayesian Framework for Inferring Background HIV Incidence: An Application Using Tenofovir Drug Levels (S3-02), David Glidden, PhD, University of California San Francisco, San Francisco, USA
Estimation of Dapivirine vaginal ring efficacy in the HOPE trial (S3-03), Alex Luedtke, PhD, University of Washington, USA
Evaluating vaccine efficacy of a candidate HIV vaccine vs. counterfactual placebo: Immune Mediator Approach (S3-04), Peter Gilbert, PhD, Fred Hutchinson Cancer Research Center, University of Washington, USA
Design for active-arm trial with counterfactual placebo Incidence based on Recency test (S3-05), Fei Gao, PhD, Fred Hutchinson Cancer Research Center, University of Washington, USA