Governance

The GTSC is responsible for the overall decision making related to the trial including the strategic direction and operational structure of the trial including setting research questions, protocol and domain development, the inclusion of any trial related sub-studies, the research data analysis and final reporting of research findings including publication oversight.

The membership of the GTSC consists of lead representatives from infectious disease and orthopaedic surgical disciplines from each participating country, as well as experts in adaptive trials, statistics, microbiology, chairs of trial working groups, a consumer PJI expert and the Global project manager.

The DSMC membership is independent of steering committees, working groups and any sponsor Institute of the trial. The DMSC has the role of monitoring the safety and efficacy of the trial including patient safety and quality control of data as well as recruitment and the application of trial specific adaptive platform rules which have been set at the commencement of the trial.  The DSMC, advise trial committees on all these areas of the trial.

The DSMC is composed of clinician and research members that are knowledgeable in the fields of prosthetic joint infections (PJI), surgical treatment of PJI, adaptive platform research trials, the pharmacological treatment of PJI, and research statistics.

We are currently working on finalising the membership of this group.