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PHEPREN & GFBR Seminar: Ethics of adaptive trial designs
The urgency of the COVID-19 pandemic has necessitated the investigation of multiple potential therapies in a timely way. In this context, adaptive trials are taking place to investigate multiple treatments and that are intended to continue beyond the evaluation of any one treatment. These complex trials have the potential to answer more questions efficiently and improve care for research participants by dropping therapies that are shown to be ineffective, but they present challenges. How should the risks and benefits be communicated to participants, understanding that the benefit:harm ratio may change over the course of the study? What consent model is appropriate for such dynamic trials? And how can regulators and research ethics committees be supported to understand and evaluate these statistically and logistically complex trials?

The 2017 Global Forum on Bioethics in Research (GFBR) meeting focused on a range of novel trial designs, including adaptive trials. The full GFBR meeting report is available at this link. This PHEPREN and GFBR seminar will reflect on the GFBR meeting conclusions and the ethics of current COVID-19 adaptive trial, including RECOVERY, Solidarity and REMAP-CAP.

Chair: Ross Upshur, University of Toronto, Canada
Srinivas Murthy, BC Children's Hospital Research Unit, Canada
Fyezah Jehan, Aga Khan University, Pakistan
Jerome Singh, University of KwaZulu-Natal, Durban, South Africa; and Dalla Lana School of Public Health, University of Toronto, Toronto, Canada

To submit questions in advance please email epidemicsethics@theglobalhealthnetwork.org

Further details available at https://epidemicethics.tghn.org/seminars/.

Nov 16, 2020 01:00 PM in London

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