Patient recruitment has long been a key challenge in clinical trials and is particularly relevant in our current treatment landscape for glomerular diseases considering the number of new agents that are under investigation. This important topic was discussed by Jai Radhakrishnan, MD, MS, following the National Kidney Foundation (NKF) 2024 Spring Clinical Meetings (SCM24).

Following these proceedings, featured expert Jai Radhakrishnan, MD, MS, was interviewed by Conference Reporter Associate Editor-in-Chief Rick Davis. Dr Radhakrishnan’s clinical perspectives are presented here.

Regarding challenges with and obstacles to recruiting patients with glomerular diseases to participate in clinical trials, a main reason for someone not wanting to participate is suspicion—patients do not want to be “guinea pigs.” There may also be concerns about the inconvenience of the scheduled visits that are required because of the more intensive monitoring of patients during the trial. The third reason involves transportation issues, in that patients may have to travel far. Since most rare diseases are not represented in a lot of clinical trials, there may only be a few research centers that are performing these trials, and they may not be located near where a patient lives.

Patient recruitment for clinical trials is particularly relevant in our current treatment landscape for glomerular diseases, especially immunoglobulin A nephropathy (IgAN), given the number of new agents that are under investigation, as discussed in the sessions “IgAN: From Famine to Feast” and “The IgA Nephropathy (IgAN) Treatment Pipeline: What’s Here and What’s Next?” at SCM24.

To address these challenges, I think that spreading awareness and improving patient engagement are important, and there are a number of foundations that are very helpful in this regard. For example, the IgA Nephropathy Foundation holds patient-centered meetings to inform patients and promote awareness about clinical trials that may be of relevance to them. Some foundations also list all the clinical trials with the contacts of the site investigators who might be in close proximity to the patient.

At my center, we provide information on clinical trials during Nephrology Grand Rounds. In addition, if I have a patient in my clinic who I think would have a chance of enrolling in a clinical trial, then I will briefly mention to that patient that they would have access to new and innovative treatments that are not available to the general public and that they would also be getting very close disease-specific monitoring from experts in the field. Since patients are actually being monitored more frequently in clinical trials, we can make changes depending on their response, or lack of response, to therapy.

Of course, everything is electronic within the hospital systems that we now have, so once we get an Institutional Review Board approval to search for patients, we run the database and see how many potential clinical trial patients there are in the system. We will likely have their recent laboratory tests to see if they are eligible to participate, then we can approach the physicians who are caring for those patients because the patients cannot be approached directly.

Another factor that is vital to point out to the patient is that entering the trial is beneficial not only to themself but also to society at large. If a treatment is available that can help other people in the future, I think that they would be playing a very important role in this. There are also fears of the unknown, but the point is that there is this concept of patient autonomy, which is intrinsic to all clinical trials, and patients need to understand that participation is completely voluntary. They can withdraw at any time without any penalty and go back to their normal situation. Then, in terms of transportation and the costs that are associated with transportation, most clinical trials—if not all—provide reimbursement for transportation. Further, nurses or laboratory technicians can be sent to the patient’s home to do all the clinical trial visits, including blood draws, which can reduce patient travel. The rest can be done through the telephone or remote patient monitoring. These are some of the ways that we address the reluctance of patients to participate in clinical trials.

Lastly, artificial intelligence (AI) will have an increasingly important role in clinical trial recruitment and management. Usually, there is a human trying to figure out whether the patient meets the screening criteria; however, this can also be done automatically using AI, which makes the screening process very easy. Now, there are third-party vendors in many clinical trials that are integrating AI and human interactions, but I think that AI is entering the field to essentially screen patients. Once the screening is done, the patients who look promising for the trial can be contacted directly to see if they are further interested in enrolling. If they are, we can provide more information. That is the way the clinical trial space is moving currently.