The Value of Sound Research Practices Even Facing Pandemics

摘要

Edwards (2013) questions the rationale for restricting new treatments for a pandemic to those that have been proven in confirmatory trials because the precautionary principle guiding most regulatory decisions may not apply in a pandemic setting. She seeks to replace clinical trials in a deadly pandemic with faster and wider therapeutic access and with alternative methods of confirmation. Her position arises fromoverestimating the ease of determining the true level of a pandemic emergency and fromunderestimating the flexibility of existingmethods for randomized trials. As a result, Edwards dramatically understates the potential dangers of dispensing with standard regulatory methods.