SISAQOL-IMI is a public-private collaborative research project under the Innovative Medicines Initiative (IMI). Forty-one stakeholder groups are involved in the partnership, including researchers from the pharmaceutical industry, academia, non-profit associations, cancer institutes, regulators, and patient advocacy organisations.
The goal of the SISAQOL-IMI initiative is to create international recommendations on how to analyse PRO data in clinical trials. In order to be successful, these recommendations need to be supported by a broad consensus, balancing different needs and requirements.
It is hoped that these guidelines and tools would facilitate the analysis of PRO outcomes and would result in more reliable findings, improved interpretability and faster dissemination of data that stem from a higher quality use of statistical methods.