There are many consequences of heart failure (HF), including symptoms, impaired health‐related quality of life (HRQoL), and physical and social limitations (functional status). These have a substantial impact on patients' lives, yet are not routinely captured in clinical trials. Patient‐reported outcomes (PROs) can quantify patients' experiences of their disease and its treatment. Steps can be taken to improve the use of PROs in HF trials, in regulatory and payer decisions, and in patient care. Importantly, PRO measures (PROMs) must be developed with involvement of patients, family members, and caregivers from diverse demographic groups and communities. PRO data collection should become more routine not only in clinical trials but also in clinical practice. This may be facilitated by the use of digital tools and interdisciplinary patient advocacy efforts. There is a need for standardization, not only of the PROM instruments, but also in procedures for analysis, interpretation and reporting PRO data. More work needs to be done to determine the degree of change that is important to patients and that is associated with increased risks of clinical events. This ‘minimal clinically important difference’ requires further research to determine thresholds for different PROMs, to assess consistency across trial populations, and to define standards for improvement that warrant regulatory and reimbursement approvals. PROs are a vital part of patient care and drug development, and more work should be done to ensure that these measures are both reflective of the patient experience and that they are more widely employed.

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Patients are ultimately the end-users of medical therapies and need to be actively integrated as contributors and decision-makers in the process of product development throughout product lifecycles. This is increasingly being recognized by patients, investigators, regulators, payers, sponsors, and medical journals. However, cardiovascular research remains behind other fields in terms of the extent of patient involvement and awareness of clinical trials in cardiovascular research. True patient partnerships in cardiovascular therapeutic development may permit more rapid recognition of unmet needs, ensure alignment of product development priorities with patient priorities, improve efficiency of trials (e.g. recruitment), and ensure outcomes of value to patients are being measured in trials (e.g. quality of life). This paper reviews ongoing initiatives and remaining opportunities to accomplish contributive patient involvement in cardiovascular clinical research.

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306 Background: Renal cell carcinoma (RCC) is increasing in global prevalence, thereby increasing burden to health systems, and most of all, to individual patients and their families. Little is known about the variations in patient experience and best practices among countries. Here, we report on the second biennial Global Patient Survey on the diagnosis, management, and burden of Renal Cell Carcinomas conducted by the International Kidney Coalition (IKCC) worldwide in 13 languages. The aim of the survey was to improve collective understanding and to contribute toward the reduction of the burden of kidney cancer around the world. Methods: A 35-question survey on the diagnosis, management, and burden of RCC was designed by a multi-country steering committee to identify geographic variations in 6 topics: patient education, experience and awareness, access to care and clinical trials, best practices, quality of life, and unmet psychosocial needs. The survey was distributed to patients with kidney cancer and their caregivers in 13 languages, through IKCC’s 46 Affiliate Organisations and social media from 29 Oct 2020 to 5 Jan 2021. Results: 2,012 responses came from 41 countries. Survey results were analysed using cross-tabulations by an independent third-party organisation. The full global report is publicly available, as well as 7 individual country reports where at least 100 responses were received. 42% reported that the likelihood of surviving their cancer beyond 5 years was not explained Just over half (51%) reported that they were involved as much as they wanted to be in developing their treatment plan. 56% experienced barriers to their treatment 41% indicated that “No one” discussed cancer clinical trials with them 31% were invited to take part in a clinical trial 45% self-reported that they were insufficiently active 50% indicated that they ‘very often’ or ‘always’ experienced disease-related anxiety. 26% ‘very often’ or ‘always’ experienced stress related to financial issues 55% indicated that they ‘very often’ or ‘always’ experienced a fear of recurrence 52% reported having talked to their doctor/healthcare professional about their concerns 48% had been offered a biopsy in the past with only 3% refusing; 47% would be willing to undergo biopsy in the future Patients aged ≤65 experienced more barriers to quality care, understood their disease less well, and experienced a longer time to diagnosis. Conclusions: The IKCC and its global affiliates will be using the results to ensure that patients’ voices are heard. Actionable points will suggest future projects. Individual countries can use their reports to advance their understanding of patient experiences and to improve local care.