 This is the Year 1 Executive Summary for CISACWAL IMI. CISACWAL IMI stands for the Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials under the Innovative Medicines Initiative. It is co-led by the European Organization for Research and Treatment of Cancer, the EURTC, and Böhringer Engelheim. CISACWAL IMI has been formed to generate recommendations on the design, analysis, and interpretation of patient-reported outcome data in cancer clinical trials. A patient-reported outcome, also known as a PRO, is a measure of the experience or view of a participant in a clinical study. PROs may include patient assessments of health status, quality of life, or symptoms. CISACWAL IMI consists of 41 organizations from 15 different countries organized into seven stakeholder groups. These stakeholders are academic institutes, industry, non-profit cancer organization, small to mid-size enterprises, contract research organizations, regulatory authorities, health technology assessment agencies, and patient representatives. In total, 150 people from these organizations are involved throughout the eight different work packages on CISACWAL IMI. The aim is to make recommendations on how to use patient-reported outcome measures in cancer clinical trials. More specifically, we aim to find the best method on how to analyze the data to make it easier to compare findings from different studies and how to interpret and present the data so that it is easy to understand for clinicians, patients, and the wider community. This will increase the quality of clinical studies and thereby help improve information for patients and clinicians about expected side effects and how the intervention may affect their quality of life. This will therefore provide a more reliable basis for shared decision making between patients and physicians and improve patient care. In 2021, the first year of the project, a pilot survey was created on the broad questions and topics that CISACWAL IMI wanted to address. The aim of this survey was to ask the different stakeholders what PRO objectives and endpoints were considered important to them. They were also asked to provide key references and guidelines that they used for different types of studies. All 41 CISACWAL IMI organizations responded to the survey. Before discussing the results of the pilot survey, I would like to review some key terms and concepts. To begin with, CISACWAL IMI aims to create recommendations for randomized controlled trials and single-arm studies. Randomized controlled trials are trials in which the participants are divided by chance into separate groups that compare different treatments or other interventions. Single-arm trials, also known as non-randomized trials, are trials in which everyone enrolled receives the same experimental treatment. Clinical trials can have different peer-related aims and objectives. These include three broad types that are commonly used. Superiority objectives aim to show that participants receiving the investigational treatment have better or superior outcomes than the comparison treatment received by the control group. Equivalence, or non-inferiority objectives, aim to show that participants receiving the investigational treatment have outcomes that are not worse or are non-inferior than the comparison treatment received by the control groups. Finally, exploratory, sometimes called descriptive objectives, are used to describe the patient's symptoms and functionings without testing them. In clinical trials, endpoints are outcomes that are objectively measured to see whether treatment works or not. PIRO endpoints are endpoints that are based on patient-reported outcomes. Commonly, a clinical trial will include multiple endpoints, that includes primary endpoints which are the main measure of whether a treatment works and secondary endpoints which are supportive measures of whether a treatment works and other effects. Now having reviewed these key terms and concepts, I will highlight some of the main takeaways from the pilot survey. This table summarizes the survey results. The questions focused on whether a particular type of PIRO objective or PIRO endpoint would be considered or not. Randomised controlled clinical trials and single-arm trials were considered separately. All scenarios that were endorsed by more than two-thirds of the participating organisations are shown in green. Half to two-thirds are shown in yellow and less than half are shown in red. Overall, there was high endorsement, more than two-thirds, for PIRO objectives used in the Randomised controlled clinical trial setting. In contrast, for single-arm trials there was less support for using PIRO endpoints for superiority or non-inferiority objectives. Participants also considered 13 different types of PIRO endpoints. There was a higher number of endpoints achieving two-thirds endorsement in the setting of randomised clinical trials compared to single-arm trials where the results were more mixed. The endpoints shown in red did not reach the necessary agreement and were considered less important to explore further. A primary aim is that the recommendations generated in CISQUAL IMI will be agreed through consensus and used by all stakeholders involved in PIRO data analysis. Therefore, there are yearly consensus meetings to vote on initial recommendations. Each of the 41 organisations have a named representative who organises the response to the Consensus Survey on behalf of their organisation during the meetings. In 2021, the consensus meeting was held virtually between 17th and 18th March. During this consensus meeting, the pilot survey was presented along with an overview of the work package's objectives, their work progress and the plans for the first year. Different stakeholder groups including patient representatives shared their perspectives on the current use of PIROs and their expectations for the CISQUAL IMI consortium. Further discussions were initiated on the objectives that were found relevant by the majority and it was agreed that all objectives that did not have a majority vote should be kept on the list for evaluation. The survey results will be used to prioritise the endpoints that are most relevant to the stakeholders when developing the future CISQUAL IMI recommendations. Building on the results from the survey, the discussions and the recommendations from the consensus meeting, the scientific work packages continued their work. A series of harmonisation meetings were held before the next consensus survey was launched to ensure that work packages followed a common strategy leading to proposed recommendation statements that were then discussed at the next consensus meeting in March 2022. We were really pleased with the progress and collaboration within the consortium in 2021. In 2022, the consortium aimed to reach further consensus on key issues in PIRO analysis.