All health‐care systems are under financial pressure and many have therefore developed value frameworks to assist decision making regarding access to treatment. Unfortunately, many frameworks simply reflect the clinically focused values held by health‐care professionals rather than outcomes that also matter to patients. It is difficult to define one single homogeneous set of patient values as these are shaped by social, religious and cultural factors, and health‐care environment, as well as many factors such as age, gender, education, family and friends and personal finances. Instead of focusing on an aggregated set of values, frameworks should attempt to incorporate the broader range of outcomes that patients may regard as more relevant. Patient advocates are well placed to advise assessment bodies on how particular therapies will impact the patient population under consideration and should be closely involved in developing value frameworks. In this paper, a group of patient advocates explore the varying definitions of patient value and make positive recommendations for working together to strengthen the patient voice in this area. The authors call on framework developers, the patient advocacy and research communities, the health‐care industry and decision‐makers to undertake specific actions to ensure patient value is included in current and future value frameworks. This is justified on compassionate and economic grounds: better health outcomes result when patients receive treatment tailored to individual needs. Paying attention to the patient perspective also results in better use of resources—a goal that should appeal to all stakeholders.
Patients with high-risk renal cell carcinoma (RCC) experience high rates of recurrence despite definitive surgical resection. Recent trials of adjuvant tyrosine kinase inhibitor therapy have provided conflicting efficacy results at the cost of significant adverse events. PD-1 blockade via monoclonal antibodies has emerged as an effective disease-modifying treatment for metastatic RCC. There is emerging data across other solid tumors of the potential efficacy of neoadjuvant PD-1 blockade, and preclinical evidence supporting a neoadjuvant over adjuvant approach. PROSPER RCC is a Phase III, randomized trial evaluating whether perioperative nivolumab increases recurrence-free survival in patients with high-risk RCC undergoing nephrectomy. The neoadjuvant component, intended to prime the immune system for enhanced efficacy, distinguishes PROSPER from other purely adjuvant studies and permits highly clinically relevant translational studies.
Portfolio Chair 4 | Deborah Maskens MA, MSM, Vice Chair 5 | Kathy Oliver BA, Chair and Co-Director 6 | Ananda Plate Chief Executive Officer 7 | Erin Schwartz MSW, VP of Global Engagement 8 | Nicole Willmarth PhD, Chief Mission Officer 9This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. Abstract Context: Patient-reported outcomes (PROs) are used in parallel with clinical evidence to inform decisions made by industry, clinicians, regulators, health technology assessment bodies and other health-care decision-makers. In addition, PRO data can also guide shared decision making and individual patient choice. Yet, the quality of many PROs in cancer clinical trials is suboptimal and requires improvement to add value to health care and policy decision making. Objective: To show how the integration of the patient and/or patient advocate at all stages of PRO development can help to realize the full potential of PROs. Methods: We examined the literature to show that the patient voice is often absent from the planning and implementation of PROs in cancer clinical trials. Good practice examples from the literature were combined with guideline recommendations, training or educational resources, and our own experience to create detailed practical steps for the inclusion of patients and/or patient advocates throughout PRO development.Results: Patient or patient advocates can play an active role in shaping PROs that are meaningful to the patient. They can contribute to content, choice of medium and implementation in a way that may support PRO completion and minimize missing data. Patients and their advocates can work to ensure PRO findings are disseminated appropriately in a way that is accessible to patients. Conclusion:This practical guidance aims to optimize PRO development and implementation in clinical trials, resulting in robust, relevant data that reflect the patient experience and that support decisions made by all stakeholders involved in research and health care.
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