 What is CICICUL IMI? CICICUL IMI stands for setting international standards in analysing patient reported outcomes and quality of life endpoints in cancer clinical trials. IMI stands for the Innovative Medicines Initiative. CICICUL IMI is a private public collaborative research project under the Innovative Health Initiative. CICICUL IMI is made up of 41 stakeholder groups. This includes researchers from the pharmaceutical industry, academia, non-profit associations, cancer institutes, regulators and patient support organisations. What is the goal of CICICUL IMI? CICICUL IMI was formed to generate recommendations on how to standardise the use, analysis and interpretation of patient reported outcome data in cancer clinical trials. Patient reported outcomes are called PROs. We'll explain these further on. Our goal is to set in place guidance that helps standardise the way PRO data is reported, presented and visualised to make results clearer and easier to compare. These guidelines will ensure that the information collected in patient reported outcomes is consistently analysed using a statistical, high quality and uniform process. These results will be clearly presented to a high study quality and will ensure a better comparability across trials. In drug development, it's important to find out how treatments affect how patients feel and function in their daily lives. This information is essential when weighing up the benefits and risks of a medicine. Ultimately, these tools and resources should ensure that cancer clinical trials accurately capture how patients feel or function during their treatment. This will then help in future decision making and improve patient satisfaction. What is a clinical trial? Clinical trials are research studies that are aimed at evaluating a medical, surgical or behavioural intervention. They are the primary way that researchers find out if a new treatment like a new drug or diet or medical device is safe and effective in people. Often, a clinical trial is used to learn if a new treatment is more effective and or has less harmful side effects than the standard treatment. What are PROs? PROs are reports that come directly from patients using patient questionnaires. PROs provide important information on how patients feel or function in their daily lives and can be used in a clinical trial setting to measure the impact of new treatment on a patient's quality of life or by healthcare professionals to provide information about issues affecting their patients. PRO questionnaires monitor a patient's social, emotional, physical and psychological state during and after cancer treatment. The data collected from PROs help decision makers such as the European Medicines Agency understand more about the benefits and risks of new medicines. What are the difficulties with PROs? Clinical trials in cancer are run by universities, pharmaceutical companies and other organisations. Therefore, different people have different ways of collecting and analysing PRO data. This makes it difficult for decision makers to compare the results of cancer trials easily and fairly. To address these challenges, the CICICL IMI project was established. So what does CICICL IMI do? It is a four-year collaborative project conducted by an international multi-disciplinary consortium led by the European Organisation for Research and Treatment of Cancer and Böhringer Ingelheim. Researchers working on CICICL IMI will agree on and publish a set of guidelines on how PRO data should be collected from patients, then analysed and presented to people who make decisions in healthcare. Why is this research important? The project is good news for patients taking part in cancer clinical trials as their experiences will be better captured alongside valuable information on treatment, risks, benefits and tolerability. This project and its generated recommendations will be of critical importance to organisations like the European Medicines Agency and the Food and Drug Administration, where PRO data can be presented uniformly across trials and will help support fair and informed decision making. Rebust and meaningful PRO data may also lead to improved shared decision making between patients and their treating physicians. This in turn may lead to improved patient satisfaction, an increased likelihood of adherence to treatment, a higher likelihood of treatment success and a reduction in healthcare cost. This four-year collaborative project will develop a set of standards for the design, analysis, interpretation and presentation of patient reported outcome data for cancer clinical trials. Setting international standards of patient reported outcomes and quality of life endpoints in cancer clinical trials, CICICL is a public, private, collaborative research project under the Innovative Medicines Initiative.