• Figure 1

    Building a community practice-based nephrology clinical trial program

Bringing Nephrology Clinical Trials to Patients: The Role of Community Practices

Suneel Udani Suneel Udani, MD, FASN, is medical director and Nancy Cipparrone, MA, is director of research at Nephrology Associates of Northern Illinois and Indiana, Hinsdale, IL. Peale Chuang, MD, FASN, is the clinical research director for Metrolina Nephrology Associates, Charlotte, NC.

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Peale Chuang Suneel Udani, MD, FASN, is medical director and Nancy Cipparrone, MA, is director of research at Nephrology Associates of Northern Illinois and Indiana, Hinsdale, IL. Peale Chuang, MD, FASN, is the clinical research director for Metrolina Nephrology Associates, Charlotte, NC.

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Nancy Cipparrone Suneel Udani, MD, FASN, is medical director and Nancy Cipparrone, MA, is director of research at Nephrology Associates of Northern Illinois and Indiana, Hinsdale, IL. Peale Chuang, MD, FASN, is the clinical research director for Metrolina Nephrology Associates, Charlotte, NC.

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The nephrology field has witnessed significant advancements in treating both common and rare kidney diseases in recent years. These breakthroughs have energized the medical community and pharmaceutical industry to develop innovative therapies further. However, transitioning from development to clinical use, including executing phase 2 and phase 3 trials, remains challenging. One of the focal points in these trials is achieving recruitment goals and ensuring a diverse representation of clinical trial participants, including traditionally underrepresented groups.

Conducting research in community practices provides potential advantages in achieving this broad range of goals, as it integrates trials with patient care, enhancing trust and recruitment. The inclusion of varied patient scenarios enhances the applicability of findings to real-world medical settings, thereby forming a valuable link between research and clinical practice that stands to benefit a more diverse range of patients. “As a community, we work collaboratively to ensure the success of clinical trials through our partnership with FDA [U.S. Food and Drug Administration] via the Kidney Health Initiative and forums [in which] people with kidney diseases, trialists, industry sponsors, and clinicians can discuss and exchange ideas,” said Melissa West, ASN Senior Director for Strategic Relations and Patient Engagement. “ASN's efforts to accelerate innovation and expand patient choice require ‘building research readiness, inclusiveness, and translation in kidney medicine, which requires championing clinical trials.’ Adding the perspective of community practices, where people with kidney diseases receive their care would greatly enhance our discussions and potential for success” (1).

Community-based nephrology practices have yet to traditionally have the ability and capacity to build and sustain a clinical research program. We propose a framework based on our experiences as a potential guide to build more widespread community, nephrology-based clinical research programs (Figure 1).

Figure 1
Figure 1

Building a community practice-based nephrology clinical trial program

Citation: Kidney News 15, 12

Part 1. Establishing value of a clinical research program

Community practices, typically physician-operated and financed, require upfront investments in staff, equipment, and research space. Demonstrating the clinical research program's value is vital for securing financial support. These practices often collaborate with dialysis organizations to establish dialysis clinics, and a clinical research program's investment can be presented similarly.

The initial investment can be categorized as financial support for research staff and physical space. While some research space can be integrated into clinical care areas, separate space is essential for storing clinical trial documents and study equipment, such as phlebotomy tables, centrifuges, and electrocardiography machines. The required amount varies based on the number of research sites and staff hired.

Similar to any joint venture, the initial years of operation should be seen as an investment in the program, without immediate financial returns. Nonetheless, there are non-financial benefits that can be highlighted to support the initial required investment. Participation in clinical trials provides access to the latest research findings and collaboration opportunities with experts and reinforces the practice's reputation as a nephrology research leader, attracting new patients. Clinicians also appreciate clinical trials as alternatives to off-label treatments for progressive kidney diseases, benefiting patients and advancing nephrology.

To ensure sustainability, the practice and research team must devise a financial plan, outlining annual progress and transitioning from initial investments in staff and facilities to generating revenue distributed among participating members.

Part 2. Building and supporting the team

Effective leadership is vital, encompassing logistical management and clinical expertise. Hiring an experienced research director skilled in research operations, including budget management, timelines, and regulatory compliance, is essential. This role is often assumed by someone with research coordinator experience, expanding responsibilities to evaluate and hire research coordinators, assess study protocol feasibility, negotiate research study budgets and contracts, and complement the clinical director. The clinical director, ideally, comes from within the practice and is an individual with trusted clinical credibility, research trial experience, and sufficient availability to direct time.

Once leadership is established, the next step is assembling a team of principal investigators with similar qualities to the clinical director and research coordinators who are dependable and have demonstrated the ability to pay careful attention to detail.

To ensure program success, uniform expectations and requirements for the entire team, including standardized training in Good Clinical Practice and trial execution, must be established. Finally, to ensure sustainability, financial support for investigators to offset clinical time loss should be a goal.

Part 3. Trial selection

Choosing clinical trials for a community practice-based research site involves evaluating multiple factors to optimize decision-making; factors to consider can depend on the capacity and interests of the program and are outlined in Table 1.

Table 1

Factors to consider in selecting clinical research studies

Table 1

Part 4. Trial execution

After securing institutional support and assembling the research team, execution follows. Community-based research programs can operate efficiently in streamlining study approval by using a central institutional review board (IRB) and integrating clinical trial space with clinical facilities. The use of a central IRB and the ability of a capable research director to singularly negotiate contracts and budget can shorten start-up time.

Once active, recruitment efforts begin, and although challenges persist, efforts should focus on understanding patient and clinician motivations for trial participation while building trust as a care partner. Outreach can be directed to patients and treating clinicians using the following two approaches.

  1. Publicize clinical trial activity on the practice website, in waiting rooms, and on social media. Encourage interested individuals to contact the research team, even if no suitable trial is available immediately, and invite them to be a part of a database of individuals to be contacted if future studies that are appropriate to their condition become available.

  2. Search the medical record database to identify individuals who may qualify for clinical trials based on their medical history. However, to reinforce the research team's position as a care partner, the team should respect the patient-physician relationship by consulting a patient's primary nephrologist before contacting a patient to discuss their care and whether trial participation would be appropriate. This is done to ensure that the patient's nephrologist is involved in the decision-making process and that the patient is fully informed about all of their options.

Ultimately, for both patients and referring clinicians, trust in the research process and program is fundamental. Accordingly, the study team must ensure that the study design aligns with best practices, including the principle of equipoise for randomized clinical trials. Success for a research program cannot be measured by enrollment numbers but by how successfully the program is considered a partner in patient care.

Although this process can require time to develop, building a sustainable and successful program requires patience, persistence, and partnership so that trusting patient-clinician and clinician-investigator relationships, which are crucial for successful recruitment and retention, can develop.

Recent breakthroughs have revitalized the field of nephrology, spurring innovative therapies and clinical trials. The exciting advancements and increased investment are vital to counteract recent trends of a declining nephrology workforce. Transitioning from development to commercial use remains challenging, with participant diversity and representation being important considerations for clinical trial execution. Community-based research programs can play an important role in this endeavor.

The authors acknowledge the editorial support of Barbara Gillespie, MD, MMS, FASN, vice president and Therapeutic Head of Nephrology at Fortrea, Durham, NC.

Dr. Udani reports receiving research funding support from AstraZeneca, Bayer, Boehringer Ingelheim, Dimerix Novartis, and Travere and receiving consultancy honoraria from Amgen, Boehringer Ingelheim, Calliditas, and Travere. Dr. Chuang and Ms. Cipparrone report no conflicts of interest.

Reference

1.

American Society of Nephrology. ASN Alliance for Kidney Health. Goals. https://www.asn-online.org/about/

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