As most nephrology specialist know, kidney disease is a global epidemic. As much as 10 percent of the world’s population is now affected by chronic kidney disease (CKD), and millions of people die each year because they do not have access to affordable treatments. Diabetes and hypertension are the leading etiologies, and cardiovascular disease is the most common cause of death in CKD patients. Yet CKD gets far less attention or research investment than many other prominent areas of research, including cancer, diabetes and cardiovascular disease.
This is one of the many reasons I’m excited to serve as a panelist at this year’s Global CardioVascular Clinical Trialists forum (CVCT), which takes place in Washington DC December 1-3. A global panel and group of speakers will highlight recent trials and evaluate viewpoints from regulators, industry and investigators. This is a unique opportunity to foster meaningful collaboration among specialists and across different stakeholders, all with the common goal of facilitating more approvals for therapies in CKD patients.
CVCT brings together investigators, trial scientists and statisticians, regulators, sponsors, payers, CROs, and key opinion leaders from across the cardiovascular – and nephrology -- communities, which is good news for patients. We need more industry stakeholders to be focused on directly investigating CV outcomes in kidney patients, so the results are directly applicable and advance us towards more renal safety data and drug approvals in CKD patients. And unlike bigger and more traditional scientific meetings, such as the American Society of Nephrology (ASN) annual meeting, CVCT is more intimate thus allowing direct conversations between panelists and attendees; CVCT is also focused on publishing papers on topics that are discussed.
CVCT encourages cross discipline knowledge-sharing about the science of clinical trials from protocol design to result interpretation, and explores new therapeutic options and future opportunities in the cardiovascular field. In past years, roughly 20 percent of the attendees at CVCT have been nephrologists because it provides the chance to work with experts outside of cardiology on issues of importance to CKD patients. Having all of these stakeholders in the same room is critical to innovation in these collective fields, as it creates a forum to share unique perspectives, push back on accepted norms, identify gaps, and generate solutions together.
I am particularly excited to note that this year’s event has an entire section devoted to cardiovascular outcomes in CKD patients. These speakers and panelists are among colleagues I’ve collaborated with on trials, at the FDA, and through my involvement at KDIGO (Kidney Disease Improving Global Outcomes) and at KHI (Kidney Health Initiative, a novel partnership between FDA, Academia, ASN, and Industry).
I will serve as a panelist on a session titled “Cardiovascular Drug Trials — and the Lack Thereof — in Late Stage CKD.” This session, which will be co-chaired by ASN and the Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), will explore a variety of issues, important to our patients, including, the extent and consequences of excluding late stage CKD patients from cardiovascular outcomes trials; ongoing cardiovascular prevention trials in CKD patients; and the approvability of cardiovascular drugs in CKD populations, and the benefits of claiming a new indication vs. addition to label description. A forum discussion will assess the value of a cardio-renal alliance for cardiovascular trials in CKD patients.
There are also a number of other sessions on the program calendar that bring together experts from across disease specialties to address some of the unique challenges in bringing safe and effective drugs to market for all patients. These include a presentation on Data Monitoring and Adaptive Designs for Clinical Trials; and another on transitioning from safety to efficacy in diabetes outcome trials that will include a discussion of what to expect from renal outcomes endpoints. And finally, I am excited to attend the panel discussion on transitioning from glucose lowering to cardiovascular prevention, which includes Rick Turner from QuintilesIMS’ Cardiac Safety Center of Excellence.
Then of course, I am excited to network with my peers inside the nephology and cardiovascular communities, and to spur more discussions about kidney disease and how these patients are represented in clinical research. We need more drugs for kidney patients, and we need more opportunities for these patients to participate in clinical trials.
Drug development doesn’t happen in a vacuum. It is only when stakeholders from across the research community work together and share ideas that we can continue to innovate on behalf of all patients while ensuring the safety and efficacy of the trials we lead and the treatments that come to market. Events like CVCT create opportunities for these collaborations to take root, and for cardiologists, nephrologists, and other disease specialists to work together to bring these critical issues to light.