5 tips for sponsors planning clinical trials in dialysis—Excerpts from a recent Labcorp webinar

Insight from our three guest speakers:

Laura M. Dember, MD, Professor of Medicine and Epidemiology at the University of Pennsylvania Perelman School of Medicine

Amy Young, VP and General Manager, DaVita Clinical Research

Hans-Juergen Arens, PhD, VP, International Clinical Research Services, Global Medical Office, Frenova Renal Research

Moderated by:

Barbara Gillespie, MD, MMS, FASN, VP and Therapeutic Head of Nephrology at Labcorp, Adjunct Professor, Division of Nephrology and Hypertension, University of North Carolina School of Medicine

Since dialysis patients visit their dialysis clinic 3 times a week in order to receive their life saving treatments, dialysis clinics are often viewed as an ideal setting for clinical trials. However, it’s critical to ensure the protocols do not disrupt the workflow of the dialysis staff, especially the technicians and nurses who are delivering daily care. How then can we design trials that are not just patient-centric but also dialysis-centric? On June 9, our Therapeutic Head of Nephrology moderated a discussion with an academic nephrologists and principal investigators (PI)and operational leaders from DaVita Clinical Research and Frenova in a webinar to address best practices for dialysis protocol design and trial execution. Here were some of their biggest takeaways.

1. Avoid the “Christmas tree” effect

In clinical trial design, there is often a temptation “to make the trials very complex, to add as many outcomes as possible and collect all sorts of data,” says Laura Dember, MD, nephrologist, professor of medicine and epidemiology and clinical investigator of end-stage kidney disease at the University of Pennsylvania.

The problem with this approach, however, is that it creates what Food and Drug Administration Commissioner Robert Califf coined “the Christmas tree effect.” What starts as an elegant fir tree in a forest gets cut down and heavily burdened with the weight of holiday lights, ornaments and glitter that misses the simplistic beauty of the original tree.

“His point was that the same thing happens with clinical trials,” Dember explains. “The simpler is generally better if one wants to leverage the advantages.”

2. Educating and empowering patients

For a trial to be patient-centric, it’s important to consider endpoints most impactful to patients, ones that affect how they feel and function during the study. Patients already taxed with time-consuming dialysis treatments may feel apprehensive about adding yet another deviation to their daily routines. The provision of educational materials and offering transparent discussions upfront should enable patients to endorse the meaningful goals of the study, which often includes getting new therapies for approved for them. We need to empower patients to understand the potential safety risks but also the possible gains in efficacy, so that they feel comfortable making the most informed consent decisions possible.

“Make sure you’re building in time to have the consent discussion,” adds Amy Young, vice president and general manager for DaVita Clinical Research. Given factors such as a patient’s disease burden and concerns about their care, “it really does take a discussion—and oftentimes, multiple discussions—to really work through that.”

The panel acknowledged that investing time to explain the goals, risks and benefits to patients also facilitates trust, so that patients know that their clinicians are always prioritizing their wellbeing even in their roles as investigators in clinical studies.

3. Clearly communicate staff roles and expectations

Communication is key when designing dialysis trials that reduce strain on the clinical dialysis staff, says Dr. Hans-Juergen Arens, vice president of International Clinical Research Services at Frenova Renal Research. For example, if a shift changes during a patient’s dialysis visit, it’s important that nurses from both shifts have a clear definition of the tasks and personnel involved.

“There needs to be clarity for everybody involved during the flow of the visits, along with the protocol schedule and design,” Arens explains. “The irrefutable fact is that the primary goal in a dialysis clinic is patient care. What sets the stage for success of clinical research work in a dialysis setting is to give the best possible dialysis to your patients and build clinical trial activities smartly around it.”

4. Consider how trial design can impact dialysis staff and patient enrollment

In most settings in the US, clinical investigators are not on site at dialysis units every day; on average, they are only present conducting dialysis rounds 2-4 days each month. To continue study workflow, PIs must rely on staff collaboration and communication. Specifically, the dialysis technicians and nurses must prioritize routine clinical duties and responsibilities in order to preserve chair time for each patient. To do this, it’s best to have a schedule that allows each patient to complete their treatments in a timely manner so that the staff can finish their work and shift on time.

“One of the misconceptions sponsors often believe is that the PI has control over all of the people and the things that happen in the setting,” Young says. “We really need the dialysis staff to help us administer drugs, to collect blood and potentially do other study pieces.”

Where feasible, Young also encourages reducing the strain of drug administration, as this will increase the dialysis-centricity of your trial. “It’s important to think about how the (investigational) drug can be prepared and ready, so we can minimize the prep time for (dialysis staff),” she says. “It could be in prefilled syringes, for example, versus a powder that you need to reconstitute. Things like that can really impact enrollment because it impacts the study staff.”

5. Design for diversity

Across the industry, clinical researchers are increasingly recognizing the importance of diverse representation in clinical trial design. One consideration that can make your trial accessible to a wider pool of patients is adding support for multiple languages.

“We tend to default to English and maybe Spanish in studies,” Young points out. “I’d really encourage sponsors to think about how we can be more inclusive with the languages and cultural dynamics (of a protocol) so we can increase diversity in our clinical trials.”

Want more tips on CKD clinical trial design? Watch the full presentation in our Knowledge Library.

Key quotes from the presentation

1) In clinical trial design, there is often a temptation “to make the trials very complex, to add as many outcomes as possible and collect all sorts of data,” says Laura Dember, MD, nephrologist, professor of medicine and epidemiology and clinical investigator of end-stage kidney disease at the University of Pennsylvania.

…. “His point was that the same thing happens with clinical trials,” Dember explains. “The simpler is generally better if one wants to leverage the advantages.”

2) “Make sure you’re building in time to have the consent discussion,” adds Amy Young, vice president and general manager for DaVita Clinical Research. Given factors such as a patient’s disease burden and concerns about their care, “it really does take a discussion—and oftentimes, multiple discussions—to really work through that.”

3) “There needs to be clarity for everybody involved during the flow of the visits, along with the protocol schedule and design,” Arens explains. “The irrefutable fact is that the primary goal in a dialysis clinic is patient care. What sets the stage for success of clinical research work in a dialysis setting is to give the best possible dialysis to your patients and build clinical trial activities smartly around it.”

4) “One of the misconceptions sponsors often believe is that the PI has control over all of the people and the things that happen in the setting,” Young says. “We really need the dialysis staff to help us administer drugs, to collect blood and potentially do other study pieces.”

5) “We tend to default to English and maybe Spanish in studies,” Young points out. “I’d really encourage sponsors to think about how we can be more inclusive with the languages and cultural dynamics (of a protocol) so we can increase diversity in our clinical trials.”

5 tips for sponsors planning clinical trials in dialysis—Excerpts from a recent Labcorp webinar

Insight from our three guest speakers:

Moderated by:

1. Avoid the “Christmas tree” effect

2. Educating and empowering patients

3. Clearly communicate staff roles and expectations

4. Consider how trial design can impact dialysis staff and patient enrollment

5. Design for diversity

Key quotes from the presentation

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Insight from our three guest speakers:

Moderated by:

1. Avoid the “Christmas tree” effect

2. Educating and empowering patients

3. Clearly communicate staff roles and expectations

4. Consider how trial design can impact dialysis staff and patient enrollment

5. Design for diversity

Key quotes from the presentation

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