A variety of disparities exist across the health care ecosystem. One focuses on an issue Frenova has been calling out for years: the clear imbalance between clinical trials for renal disease patients compared to clinical trials in other therapeutic areas. It may be surprising to people outside of the renal disease community that there are more people living with chronic kidney disease (CKD) (37 million)1 than there are with cancer (17 million).2 Despite the higher prevalence, between 2016-2020, there were 22,486 clinical trials conducted for cancer while there were less than 10% of that amount — only 2,227 clinical trials — for kidney diseases.3

Robert F. Kennedy once said, “The purpose of life is to contribute in some way to making things better.” For 25 years, Frenova has been working to make things better for people living with kidney disease. While Frenova has helped advance the science by working with sponsors of clinical trials, the broader drug development industry needs to step up and fight harder for kidney disease patients, to ensure the focus is on developing breakthrough therapies — that are so urgently needed.

Innovation and Education

Frenova previously shined a light on chronic kidney disease as a public health crisis where we noted that nephrology lags behind every other major disease area in the annual number of randomized control trials (RCTs) since records have been kept — more than 50 years. Making matters worse — along with the fact that there are not enough nephrology trials — many nephrologists don’t know about, nor do they know how to participate in the trials that do exist.

Similarly, we have highlighted the disparity in clinical trials for renal disease which underscored the exclusion of patients with renal disease in other trials. As we outlined in that article, reasons for this exclusion are complex. Nonetheless, the research community must come together and find a way to ensure these patients are included in clinical trials.

Other experts have arrived at similar conclusions. “It is a fact that the efficacy and the safety of treatments tested on patients without CKD cannot be assumed in CKD patients, and similarly that withholding treatment due to the presence of CKD may significantly and unfairly disadvantage those affected,” said David Harris, past-president of the International Society of Nephrology in a 2019 interview. “We need studies that include CKD patients.”4

A Better Way

We must do better for the 15% of American adults currently living with kidney disease and those afflicted worldwide. A 2015 Global Burden Disease (GBD) study estimated that, in 2015, 1.2 million people died from kidney failure, an increase of 32% since 2005.5

While this is a devastating statistic, we are heartened that, as the most experienced CKD and end stage renal disease (ESRD) trial site and trial management service provider in the world, coupled with our access to hundreds of thousands of active patients, Frenova continues to contribute to innovations and research for renal disease and advocate for a better future.

However, questions remain regarding the underrepresentation of nephrology when it comes to investment in clinical trials. These are difficult but important questions that deserve exploration. They include:

  • Does this disparity have to do with reimbursement issues?
  • Is the public not aware of the funding required to address this need?
  • What needs to be done in order to raise awareness?
  • Does the pharma industry benefit more from conducting research in other areas such as oncology?
  • Where do the National Kidney Foundation (NKF) and American Society of Nephrology (ASN) fit in addressing this disparity?
  • Is it that there simply are no appropriate drug targets in renal disease currently?
  • Are the endpoints too obscure or not meaningful enough? How can they be refined?
  • Where is precision medicine in nephrology and why does it not exist?

Closing the Loop

While we all work to resolve these complex issues, Frenova continues to move forward and do our part. For example, we recently announced a new initiative to develop the largest renal-focused genomic registry in the world. This registry, entitled My Reason, will bring patients, their families, patient advocacy groups, physicians and researchers together in the common cause of improving the lives of people living with kidney disease. This is one way that we plan to “do better” for CKD and other kidney-related diseases.

As an industry leader, Frenova intends to catalyze the field of precision nephrology by pairing genomic data with phenotypic data. Because we’re uniquely positioned in the renal community, with access to hundreds of thousands of patients, we are privileged to fulfill an important role as a conduit between stakeholders in the health system. The first step in catalyzing this field is having volunteers in kidney disease-related clinical trials agree to share their genetic and health data with investigators and researchers. At this point, researchers are able to study this data, glean insights and gain new scientific knowledge so that others may be better helped in the future.

Finally, and just as important, any advocacy initiative should include people with lived experience. As such, our future patient advisory groups will be an important asset to us and help inform our genome-related programs.

At Frenova, we’re continuing to take action and we’re here asking you to stand with us, to take bold action informed by knowledge. Without increased investment in prevention, the total number of patients with kidney failure will likely exceed 1 million by 2030.

We must be relentless in our pursuit of further research and clinical trials. As such, Frenova urges everyone within the renal disease community to work toward overcoming any obstacles within your purview, whether it be public education, enrolling more CKD patients in trials or sharing key data and insights in order to make it easier for drug developers to pursue treatments in this area. Most of all, let’s ensure that the 37 million Americans living with kidney disease are within our scope of doing better.

Read Part II – CKD: This Silent Killer Deserves More Attention

References:

1Kidney Disease, The Basics, Kidney.org
2Cancer Statistics, Cancer.gov
3Clinicaltrials.gov
4Groups aim to include patients with CKD in clinical trials, 2019, Helio Nephrology, Helio.com
5The Global Burden of Kidney Disease and the Sustainable Development Goals, Valerie Luyckx et al., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5996218/
6Kidney Disease: The Basics, Kidney.org

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