The Kidney Conundrum

Patients with kidney disease are a special population. Unfortunately, they are underserved by current clinical trials. Despite being a large portion of those with chronic illness, they are disproportionately neglected by clinical trials. We have become the industry leader in assisting with site selection and site management for clinical studies that need to recruit and care for patients with renal disease. As we support this group, we have learned just what these trials mean to them.

Delays in trials are frustrating for us, but for some of our patients, delays represent a denial of life-changing new treatments. We can help you accelerate your timelines using our knowledge of these patients’ needs and accumulated expertise in the renal clinical trial space.

Time to market has been increasing for drug clinical trials over the last few decades. In fact, a clinical candidate now takes a full year longer to reach market than it did, on average, from 2000-2010.1 This means increased costs, with an average prescription drug’s journey to approval costing $2.6 billion in 2014, an inflation-adjusted increase of 145% compared to 2003.1 CenterWatch estimates that for more recently approved drugs, from discovery through approval, the cost was about $4 billion per new molecular entity.2 While this increase is not exclusively due to increased time to market, it is a significant contributing factor.

Between cost considerations and publicity, the clinical trial industry has neglected our patients with chronic kidney disease (CKD). Kidney disease is one of the most common ailments in our aging populace yet is understudied compared to diseases that receive comparatively more publicity, like cancer.

The combination of the clinical trial industry lacking practical experience with kidney disease and the ever-increasing timeline of protocols makes studying CKD treatments difficult. We have previously written about the Resolving 3 of the Most Common Hurdles to Clinical Study Acceleration. Notably, enrolling this patient population comes with unique difficulties.

The Renal Patient’s Unique Perspective

It can be hard to understand why patients with difficult-to-manage conditions would not volunteer to find a better solution. Our direct experience helps us design trials that reduce any undue burden on patients to help overcome such hesitation.

By simple adjustments to details like the patient’s protocol schedule, you can account for their concerns and increase enrollment. That’s why at Frenova, we look at potential study protocols and help sponsors better understand the impact of the study on patient population. We help find the operational weaknesses that would make a study difficult to execute. The research must work for both the patients and the care teams at the dialysis center. For example, Frenova recently executed a Phase IIIb trial during the height of the COVID-19 pandemic. By adjusting to a patchwork of lockdown protocols across the United States for care teams, Frenova was able to provide confidence to patients about their continued safety in the study and enroll them. We successfully activated all nine sites within three months, even with pandemic-related delays.

We have found most patients want to participate in clinical trials. Simple incentives, such as offering a stipend to cover travel and time, can have a large impact on convincing this interested but cautious population to participate, especially as there are individuals unable to work full time due to disease-related impairments.

We Are Designed to Help

Frenova starts with the patient in mind. Our patient-centric approach has made us the experts in kidney disease clinical trial enrollment.

We have integrated this approach into F1RST UP®, our exclusive alliance of expert renal trial sites. We have a record of faster start times and faster enrollments, made possible by our renal expertise and enhanced via our master agreement for each study, which simplifies the negotiation of contracts.3 Our sites have a preexisting physical and intellectual infrastructure for renal trials, meaning we are ready to handle all issues that come up during any kidney-disease-focused protocol.

In fact, we employee physicians and nephrologists that are experts in CDK and adjacent disease clinical trials. We can prevent problems before they start. Our experts provide input and suggestions during study design that facilitate a better, more inclusive trial. We use our direct experience with patients that have kidney disease for insightful and pragmatic protocols.

By taking advantage of our unique approach, you benefit from our long history of conducting clinical trials and our proximity to the patient population of interest through our exclusive partnership with Fresenius Medical Care. Our investigators enroll twice as many patients compared to those outside of the alliance.

Frenova’s deep understanding of kidney disease patients and expertise in managing sites enable us to execute clinical studies effectively and profitably.

What Does This Mean for You?

Frenova’s site network enables you to work with one company while having access to sites around the world. Frenova’s unique position ensures that we provide the most effective, real-world-tested planning and execution of studies in patients with CKD and end stage renal disease (ESRD).

To learn more, contact our experts to find out how we can help accelerate your molecule to market with our global network.
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References:

1Henry G. Grabowski and Ronald W. Hansen. Cost of Developing a New Drug. Tufts Center for the Study of Drug Development. Tufts University. November 18, 2014.
2Barbara Bolten. Fastest drug developers and their practices. The CenterWatch Monthly 2017 Aug 1;24(8). https://www.centerwatch.com/articles/13284
3Kurt Mussina and Christina Kahn. F1RST Up®: Accelerating Clinical Trial Start-Up. Frenova Renal Research.

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