Patient enrollment for clinical trials can be a challenging task especially if the patients are dealing with a chronic illness. Dialysis patients in particular are a population that need a higher level of attention to detail and care due to the complexity of their condition. It is not uncommon when we are starting up a dialysis study that our sponsor clients have many questions around the additional challenges on the enrollment of dialysis patients. After all, time equals money to the pharmaceutical client and a slow or non-enrolling trial can be very costly. Another primary point of concern is around the fact that some trial participants, even in a healthy patient population, never fully enroll.
One study by Tufts University noted some surprising data around patient enrollment, stating “it’s been estimated that about 30% of Principal Investigator’s under-enroll in a given trial, and about 20% fail to enroll a single patient.”, therefore it is easy to understand the concern of the client.
Knowing your audience is vital when enrolling participants for dialysis clinical trial studies. It is important to set up the study plan to adapt to the dialysis population.
• Review patient data: Dialysis studies tend to be very lab specific. It can be helpful to review the dialysis rounding reports or patient data prior to contacting the patient. Reviewing the data in advance will help to identify lab, medical stability, compliance or medication issues that could impact the study eligibility.
• Addressing concerns: The dialysis patient population generally have a regimented treatment plan. Some patients may prefer to do an outpatient vs an inpatient trial due to having a regular routine that they adhere to and/or regular dialysis care givers which they rely on. Many times dialysis patients have some apprehension due to the potential changes of their care plan, medication holds, or concern around the addition of an investigational medication and its possible side effects. If there are concerns from the patient, it is helpful to encourage the patient to include family members or their Nephrologist into the Informed Consent discussion.
• Plan on enrollment obstacles: It is helpful to factor in that dialysis patients in general have more comorbidities and this may result in more non-study related Adverse Events (AE’s) or Serious Adverse Events (SAE’s) and a higher level of study dropout. General stability, physical or mental challenges can all become enrollment challenges.
• Advertising and patient outreach: It is important to keep in mind the patient demographics when advertising a study in order to help reach the targeted population. It is helpful to provide both study and non-study specific flyers and brochures to dialysis units, this may help patients and caregivers become more familiarized with all research activities. Never underestimate the power of a good referral from one dialysis patient to another, this is an excellent way to reach out to new participants as they see each other and spend time in the same unit multiple times a week.
Despite a few front end challenges overall, many dialysis patient participants like the idea that they may be able to make a difference in the future of medicine even in a small way with their study participation.