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Serious adverse event reporting in investigator-initiated clinical trials

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New drugs and medical devices offer improvements in health care. Clinical research is undertaken to elucidate such benefits, but also to identify potential harms. Adverse event (AE) and serious AE (SAE) data are crucial information in drug and device development studies (Box 1). Definitions and requirements for safety reporting in Australia are outlined by the international guidelines,1 and the National Health and Medical Research Council (NHMRC) National statement on ethical conduct in human research.2 Further, the NHMRC has provided clarification on how AEs should be reported and who has responsibility for reviewing and acting on them.3 Such guidelines are practical steps to ensure safety for participants in all research involving interventions, including post-marketing surveillance and Phase IV trials (Box 2) of approved medicines, treatments and devices.

However, there is quite marked variation in how, to whom and indeed if such safety reporting is required in investigator-initiated clinical trials. Any such requirement needs to take into account the context of the study, including its phase, the existing health conditions of the participants, and the risks of the proposed intervention over and above standard care. Moreover, the burden and cost of reporting should be proportionate…