Emergency use of unproven clinical interventions outside clinical trials: ethical considerations

Emergency use of unproven clinical interventions outside clinical trials: ethical considerations
Technical Document
World Health Organisation, 12 April 2022
Open Access
Introduction
Outbreaks and other events that may become public health emergencies frequently face a lack of  safe and effective therapeutic or preventive interventions, such as drugs specific to the pathogen or condition. WHO and its partners therefore established the “WHO R&D blueprint” in 2016 to stimulate research into diseases or conditions that pose the greatest public health risks because of their epidemic potential or for which there are no or insufficient countermeasures (31). In response to the ethical duty to conduct research during public health emergencies (17), rapid, rigorous, simple clinical trials or other types of research (32, 33) are essential to establish the safety and efficacy of unproven interventions – including “off label” interventions (9) – and to discard those that are unsafe or ineffective to avoid their use in health systems. When a PHEIC is declared, “it is critical that the global research effort is rapid, robust, conducted at scale and coordinated across multiple countries” (33)…