The Trial Update is a new article type that allows authors to describe additional results from clinical trials after publication. Such additional information may include results from subset analyses, long-term follow up, and other supplementary data. The intent is to provide additional insights that are relevant for patient care and will inform the interpretation of primary trial results. The timing of such additional results must be considered carefully, since a delay in the availability of primary end point data might be detrimental to patients.
A clinical trial’s end points mature at different times: overall response rate is available before progression-free survival, and overall survival data may take years to mature. In addition, early-stage neoadjuvant trials often yield pathologic response data that are not available at first reporting, and the results of chronically administered treatments may be revealed only over many years. In these cases, a supplemental trial update is an appropriate mechanism to disseminate these important new findings.
Trial update authors should include a detailed statistical analysis plan (SAP) for the study. SAPs submitted as updates must be consistent with the Guidelines for Statistical Analyses in Clinical Trials published in JAMA and should reference a previously published study protocol. For trials that are ongoing, a completed SAP should be integrated into the published study protocol or included as an additional file.
This update includes the Trial Chambers – a sprawling structure stuffed with traps and treasures for every player, including decorative blocks, copper corridors, auto-crafting, weapons, hostile mobs, paintings, wind charge, and more!