(USA) Brain Games? – Science (Charles Piller | November 2023)
This item from the US initially was promising news for people who are at high risk for stroke. The alerts whistleblowers paint a far more depressing and tragic picture. Scientific enquiry and clinical trials are never certain, so there must be a robust system for monitoring trial results and considering serious adverse events. Even a single death should prompt the reviewing research ethics committee to suspend the ethics approval and request a follow-up safety review. Multiple deaths raise serious concerns and begs the question, did the size of the impact on the monitoring mechanism? This story is a useful case study for the professional of clinical trial research ethics reviewers and safety monitors.