A one-day symposium was held in Seattle, Washington on November 5, 2018, including a broad array of stakeholders in the HIV prevention community. The topic of discussion was the challenge of designing future HIV prevention efficacy trials, given the multiplicity and speed of changes in the field in recent years, the development and rollout of effective prevention tools, and the resultant complexity in designing trials to evaluate new HIV prevention products. The goal was to identify potential statistical trial design approaches worthy of further investigation, as well as gaps in understanding and logical next steps. We overview the themes that emerged from the presentations, panels, and floor discussions, and outline initial next steps in further exploring design options.
The organizers thank the Fred Hutch staff who were critical for making the event a success, especially Megan Rabone and Jerry Ockfen; NIAID, the Bill and Melinda Gates Foundation, and the three major NIAID-funded HIV prevention networks (the HVTN, HPTN, and MTN) for funding; the speakers, moderators, and panelists for their collaboration well advance of the event; and to the participants for engaging in the discussion. We also acknowledge Lindsay Carpp for her editorial assistance, and Zoe Moodie, Lynda Emel, and Brett Hanscom who contributed to an earlier version of this synopsis.
Dominguez-Islas, Clara, and Elizabeth Brown. 2019. “Crossover and Repeated Randomization in Event Driven Trials for HIV Prevention: Addressing the Impact of Heterogeneity in Risk in the Trial Design.” Statistical Communication in Infectious Diseases.10.1515/scid-2019-0009Search in Google Scholar
Donnell, Deborah. 2019. “Current and Future Challenges in Trial Design for Pre-Exposure Prophylaxis in HIV Prevention.” Statistical Communications in Infectious Diseases.10.1515/scid-2019-0008Search in Google Scholar
Dunn, David, and David Glidden. 2019. “The Connection Between the Averted Infections Ratio and the Rate Ratio in Active-Control Trials of Pre-Exposure Prophylaxis Agents.” Statistical Communication in Infectious Diseases.10.1515/scid-2019-0006Search in Google Scholar
Dunn, David, David Glidden, Oliver Stirrup, and Sheena McCormack. 2018 (June). “The Averted Infections Ratio: A Novel Measure of Effectiveness of Experimental HIV Pre-Exposure Prophylaxis Agents.” Lancet HIV 5 (6): Pe329–34. doi: https://doi.org/10.1016/S2352-3018(18)30045-6.Search in Google Scholar
Fleming, Thomas, Victor DeGruttola, and Deborah Donnell. 2019. “Designing & Conducting Trials to Reliably Evaluate HIV Prevention Interventions.” Statistical Communications in Infectious Diseases.10.1515/scid-2019-0001Search in Google Scholar PubMed PubMed Central
Follmann, Dean. 2019. “Tomorrow’s HIV Prevention Trials of Vaccines and Antibodies.” Statistical Communications in Infectious Diseases.10.1515/scid-2019-0007Search in Google Scholar
Gilbert, Peter. 2019. “Ongoing Vaccine and Monoclonal Antibody HIV Prevention Efficacy Trials and Considerations for Sequel Efficacy Trial Designs.” Statistical Communication in Infectious Diseases.10.1515/scid-2019-0003Search in Google Scholar PubMed PubMed Central
Glidden, David. 2019. “Advancing Novel PrEP Products - Alternatives to Non-Inferiority.” Statistical Communication in Infectious Diseases.10.1515/scid-2019-0011Search in Google Scholar PubMed PubMed Central
Murray, Jeffrey. 2019. “Regulatory Perspectives for Streamlining HIV Prevention Trials.” Statistical Communication in Infectious Diseases.10.1515/scid-2019-0002Search in Google Scholar
Wittes, Janet. 2019. “The Modern Randomized Clinical Trial: Is it Time to Sharpen a Blunt Instrument?” Statistical Communication in Infectious Diseases.10.1515/scid-2019-0005Search in Google Scholar
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