LAUSR

Introduction Probably the easiest way to ruin a clinical trial is to choose the wrong endpoint. Our assessment as to whether something works in medicine, whether treatment or diagnostic, is based on “hitting” the primary endpoint. In the rough and tumble world of clinical trials, there are few second chances, especially for new drugs or devices. Thus, it is often an “all or nothing” mentality that drives the field, and even missing the endpoint in a phase-2 trial can sap the interest and investment needed to conduct a phase-3. For trials in acute kidney injury (AKI), the first question is whether the purpose of the intervention is to prevent or treat. For prevention trials (or for diagnostics), it is unrealistic to use anything other than AKI itself as the primary endpoint. This is because powering a prevention trial for downstream outcomes is extremely difficult.