In drug development, it is important to find out how treatments affect how patients feel and function in their daily lives. This information is also essential when weighing up the benefits and risks of a medicine. In practice, it is rather difficult to obtain this information and communicate it clearly and simply.

The aim of SISAQOL-IMI is to develop recommendations on how to analyse and interpret data on health-related quality of life (HRQOL) and patient reported outcomes (PROs) in cancer clinical trials.

To do this, the project will seek to achieve consensus internationally and across stakeholder groups on the optimal use of PROs in cancer clinical trials, and gain clarity on the research objectives for the use of PROs in trials, including the definition of ‘clinically meaningful change’.

The project also aims to improve the statistical analysis of PROs in cancer clinical trials, and standardise the way findings are reported, presented and visualised. The standards should be endorsed by all relevant stakeholders.

Furthermore, the project plans to develop educational tools based on the standards; these tools will hopefully help to improve patients’ understanding and empower shared decision making.

Ultimately, the tools and resources developed by SISAQOL-IMI should ensure that cancer clinical trials accurately capture how patients feel or function during treatment. This in turn will aid in decision making for regulators, health technology assessment bodies, and, crucially, improve patient satisfaction. The findings may also be applicable to clinical trials in other disease areas.