The goal of SISAQOL-IMI is to create international recommendations on how to analyse, interpret and report PRO data in cancer clinical trials. It will also address the optimal use of PRO and gain clarity on PRO research objectives, including the definition of “clinically meaningful change.”
To be successful, these recommendations will be supported by a broad consensus across stakeholders, balancing different needs, requirements, and perspectives. It is hoped that these standards will facilitate an alignment in analysis of PRO and result in more reliable findings, improved interpretability, and faster dissemination of data, stemming from higher quality statistical methods.
Finally, SISAQOL-IMI aims to improve communication of PRO data through the standardisation of how findings are reported/displayed and through the creation of a suite of educational tools and materials for a range of audiences.