In spite of the comorbid conditions and the high costs of kidney care, the amount of information available for kidney disease patients to participate in clinical trials is limited. For many other health conditions, it’s common for specialists to refer their patients to clinical trials for treatment or additional care options, but nephrologists are far behind in this regard. With randomization of a sufficient number of patient participants to achieve sufficient numbers of outcomes being one of the main requirements to a successful trial, nephrologists still refer their patients to these trials at a lower rate than their peers.
Participants at the KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology put together an article about the potential causes for the lower referral rate among nephrology research participants.
Advantages of Nephrology Research
Even though 14% of the general US population is estimated to have Chronic Kidney Disease (CKD), nephrology research remains a research area that has historically under-served the patient population. Participants also have hope of improving their clinical outcomes while benefiting the larger CKD population.
Compared to other areas of trial like cardiology, nephrology research is also often less invasive for participants since it more often focuses on drug development than it does on procedures.
With such a large patient population, who may potentially benefit from participating in clinical trials, willing to participate in clinical trials it is interesting to note that nephrology research is far behind other areas of research (diabetes and cardiology) in referring patients to participate in these studies.
Barriers to Referring Patients to Clinical Research Studies
In reviewing the reasons for a lower referral rate among nephrology research participants, some of the main findings revolve around balancing the need for this research and avoiding placing undue burden on patients.
The Undue Burden on Patients
Many of the treatments being evaluated are already in use. Due to difficulties in conducting these studies and ensuring a high rate of adherence to the trials, many of the new trials are designed to reinforce the efficacy and safety of existing treatments. To nephrologists, this can feel like placing an undue burden on their patients with no guarantees that suitable outcomes will be measured.
Given the need for a control, some patients will also receive a placebo as part of the trial, and nephrologists might also see this as an undue burden. By submitting patients to a placebo study, the hope is that the trial will account for trial design and trial conduct. These two trial considerations, considered separately, help to determine whether the trial has a substantial randomized number of eligible patients.
Randomization of a Sufficient Number of Patients to Achieve Sufficient Numbers of Outcomes
When beginning a clinical trial, establishing a large enough participant pool is essential to producing wide range of outcomes. In nephrology research trials, other comorbidities can further reduce the number of potential participants, leading to incomplete outcomes from the trials or what can often become biased analysis.
Even if the potential participant pool is wide, recruitment can be difficult and might not meet the need for generalizability. Studies should maintain a broad pool of participants for potential future patients receiving the study intervention, and studies should avoid unnecessary exclusions.
As it relates to nephrology referrals, knowing that patients won’t be excluded as a result of unnecessary exclusions was found to be a barrier to referral.
The Importance of Adherence to Study Requirements
For a trial to have unbiased outcomes, strict adherence is a key component of trial design and trial conduct. CKD patients often already have a high burden as it relates to their own treatment and medications. Each study should not only enforce adherence to the study requirements, but it is also important that studies evaluate the likelihood of participants to adhere to the treatment plan.
Knowing that the participant pool is broad and is likely to adhere to a study’s requirements for treatment helps to reduce any concerns of an unnecessary burden on patients.
It Starts and Ends with Trial Conduct and Trial Design
Given the socio-economic circumstances driving the increase in Diabetes diagnosis in many underserved areas of the country and the costs associated with treating CKD, patients might be more likely to consider treating in clinical trials. So why are fewer CKD patients referred to clinical trials than patients with other health conditions? Most often, it is to do with trial conduct and trial design.
With a combination of factors being considered, the quality of the trial and the expected outcomes is important. Nephrologists want to ensure they are referring patients to studies that are well designed and conducted in a way that limits the amount of burden placed on patients who already have a high burden for care. By ensuring proper clinical trial conduct, studies can not only help patients in the future with new or proven treatments, the added benefit will be ensuring the trust of nephrologists in referring patients.