THE FORUM HIV PREVENTION TRIAL DESIGN PUBLIC MEETINGS SERIES

Introduction

The Forum HIV Prevention Trial Design Project convenes a series of public meetings to offer the community a powerful opportunity to review and discuss strategies together with all stakeholders to allow for less resource-intensive clinical trial options for new PrEP interventions' approval while maintaining scientific rigor. Click here to view the Topics Flowchart.

These meetings/webinars focus on issues regulators, particularly the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and African Regulatory agency, are particularly interested in receiving broader community input on. Read the full concept note here.

Past Webinars

April 13th and 14th, 2021 -  Protocol Design Considerations: Analyses for Efficacy

The two-day webinar included interactive discussions including experts from all stakeholder groups, which has been essential in moving the PrEP agenda forward towards a more feasible and ethical trial design. On Day 1, we discussed the acceptability of external controls to derive a counterfactual estimate of HIV incidence in the communities in which the trials are being conducted and how to build this into the trial design and analysis plan. It also focused on whether there is a need for an active control arm as an additional benchmark. On Day 2, we summarized findings from Day 1 and focused on ethical considerations framed around topics discussed. It also elaborated on ethical obligations to the community where the trials are being conducted.

• Download the Agenda
• Download the Webinar Report
• Watch the on-demand recording from Day 1
• Watch the on-demand recording from Day 2

Tuesday, November 10, 2020 - High-level Review of Regulatory Frameworks and the Way Forward

The second webinar discussed the potential path forward. Similar to the first webinar, the second webinar reviewed the regulatory framework for clinical trial innovation relevant for PrEP. Experts from the U.S. and South Africa provided a high-level overview. The goal of the two informational webinars was to bring the audience up to speed and facilitate their engagement in strategic discussions on forging a feasible path forward.

• Download the Agenda (PDF)
• Watch the on-demand recording

Wednesday, October 14, 2020 - High-level Review of Regulatory Frameworks and Lessons Learned to Date

The first webinar reviewed the regulatory framework for clinical trial innovation as relevant for PrEP. Experts from the EU, US, and South Africa provided a high-level overview. We then reviewed how far we have come in PrEP research in the context of the regulatory framework. Click here for more information.

• Download the Agenda (PDF)
• Watch the on-demand recording

Resources/Learning Materials

Reading Materials

Lectures

• Video 1:The counterfactual and how do we estimate it? What are randomized controlled trials, superiority trials, and non inferiority trials?
• Video 2: What are the challenges for PrEP?
• Video 3: What's next?

Interviews: Academic Perspective

Jared Baeten, MD, PhD University of Washington

Sandra McCoy PhD, MPH Division of Epidemiology & Biostatistics. UC Berkeley

Interviews: Community Perspective

Gus Cairns, MA NAM AIDSmap

Grace Kumwenda, MA, Pakachere Institute and Ntando Yola, BA, Desmond Tutu Health Foundation

Stephaun Wallace, MOL, MS, PhD, HIV Vaccine Trials Network and Stacey Hannah, MHS, AVAC

Interviews: Industry Perspective

Vani Vannappagari, MBBS, MPH, PhD ViiV Healthcare

Moupali Das, MD, MPH Gilead Sciences

Interviews: Regulatory Perspective

Rachel Baggaley, MBBS, MSc Unit Head, World Health Organization (WHO)	Hans-Georg Eichler, MD, MSc Senior Medical Officer, European Medicines Agency (EMA)
Jeffrey Murray, MD, MPH, Deputy Director of the DAVP, FDA and Charu Mullick, MD, Medical Officer, FDA	Boitumelo Semete-Makokotlela, PhD, MSc Chief Executive Officer of SAHPRA