Asking people with kidney failure what matters to them is critical for patient centered innovation. If that information can be collected in a scientifically rigorous way, it can inform industry and regulatory decision making.
The Kidney Health Initiative (KHI) is launching a new project in collaboration with the US Food and Drug Administration (FDA) to collect patient preference information on innovative renal replacement therapies (RRT). The three-year project, funded by the FDA, will produce a survey that captures scientifically valid patient preference and risk tolerance data from people with kidney failure to drive innovations in RRT. This information is increasingly important as innovation accelerates in the kidney community. The Advancing American Kidney Health initiative identified this need, directing the FDA to “develop a new survey to gain insight into patient preferences for new kidney failure treatments”.
2017 is drawing to a close, marking the end of a year that saw ASN Communities hit its stride within the nephrology social media landscape. Providing an interactive learning experience for nephrologists around the world has become the sites primary strength. Interacting on Communities reminds many practicing nephrologists of the iterative case conferences they had in residency. Both complicated and mundane discussions provide a springboard for nephrologists to finding their own answers and improving their own knowledge base.
What do Kidney Week and ASN Communities have in common? Even though one is online and the other in person, they are both destinations for kidney health professionals to discuss, network and collaborate around issues that are important to them. Kidney Week provides a physical context to build the relationships you have online.
The COVID-19 pandemic has brought new urgency to the need for alternatives to in center dialysis for people with kidney failure. Historically, integrating patient preferences into device development has been limited. Developments in the kidney community in recent years, including the KidneyX and the Advancing American Kidney Health initiative, have accelerated development of transformative devices for kidney replacement therapy.
Session on Collaborating for Innovation to Support KidneyX
Eric Hargan, Deputy Secretary at the US Department of Health and Human Services (HHS) began the second day by sharing HHS’s priorities for kidney care. First, to increase efforts at preventing, detecting, and slowing the progression of kidney diseases. Second, to provide more treatment options to people with kidney failure. Third, to increase the number of transplantable organs and develop wearable and artificial kidneys.
The growing number of clinical trials the kidney community has enjoyed over the past few years is endangered due to the COVID-19 pandemic. Concerns over the safety of trial participants and investigators are paramount and are leading to rapid changes in the conduct of clinical trials.
The US Food and Drug Administration (FDA) released “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”, updated March 27, to provide clarity to the clinical trial community. Considering this guidance and after soliciting reactions from the clinical trial community, the Clinical Trials Transformation Initiative (CTTI) hosted a webinar on March 31 titled “Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID”.
The American Society Nephrology (ASN) is pleased to announce that Raymond C. Harris, MD, FASN, has been selected as the incoming ASN Co-Chair for the Kidney Health Initiative (KHI). Dr. Harris will serve a three-year term, starting in January 2019. Dr. Harris will succeed Prabir Roy-Chaudhury, MD, PhD, FASN, who has served six years as KHI’s founding co-chair.
While dialysis is a life-saving therapy for patients with end stage kidney disease (ESKD), a variety of symptoms occur following treatment that significantly diminishes the quality of life of people living with kidney disease. A 2009 study published in the Clinical Journal of the American Society of Nephrology (CJASN) reported that patients on maintenance dialysis experience 11 unique symptoms. Patients have identified the need to alleviate these symptoms as a key research area, prioritizing it above other health outcomes. Alleviation of these symptoms could result in increased quality of life and better patient-reported outcome measures. Despite the patient demand for new therapies to address these symptoms, no drug or device has been approved by the US Food and Drug Administration (FDA) to date.