Re-Envisioning the Canadian Nephrology Trials Network: A Can-SOLVE-CKD Stakeholder Meeting of Patient Partners and Researchers.

PURPOSE: The Canadian Nephrology Trials Network (CNTN) was formed in 2014 to support Canadian researchers in developing, designing, and conducting prospective studies in nephrology. In response to the changing landscape and needs within the Canadian nephrology research community, an interest in further growth and development of the network was identified. In the following report, we describe the process undertaken to re-envision the network through the creation of 3 new committees and how the committees are facilitating change and growth within the CNTN for future sustainability. SOURCES OF INFORMATION: To understand areas for improvement and capacity building, the organization charged with overseeing the CNTN, Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD), began by conducting an environmental scan. As well, 2 informal surveys were sent to nephrology professionals (who were members of the CNTN and the Canadian Society of Nephrology) and patient partners (from Can-SOLVE CKD).
METHODS: In September 2018, 44 CNTN members and other stakeholders from across Canada (including patient partners and representatives from research funding agencies) convened for a 2-day visioning workshop in Mississauga, Ontario. The agenda for this workshop was largely based on the results from the informal surveys. CNTN leadership participated and chose other workshop participants through informal stakeholder mapping and purposeful recruitment. Patient partners were recruited to participate in the workshop through advertisement within the Can-SOLVE-CKD patient council. The survey results and discussion questions were presented to participants at the workshop who, in turn, discussed in large- and small-group session ways in which the CNTN might be expanded.
RESULTS: Surveys of patient partners indicated that they would like to see greater involvement of patients in the research process. Surveys of researchers indicated that they wanted more support and resources for coordinating prospective trials. The themes which emerged from the workshop discussions were peer review, engagement, and training. These themes were broadened and formally re-named to Scientific Operations, Communications and Engagement, and Capacity Building. A working committee, each co-led by a nephrologist with research experience and a patient partner, was created to advance each of these identified themes. An executive committee was created to provide overall strategic leadership and governance to the network. The Scientific Operations Committee conducts peer reviews; provides letters of endorsement after peer review; and holds semi-annual in-person meetings where researchers can present their proposals and obtain feedback from multiple stakeholders, including patients. The Communications and Engagement Committee publishes a quarterly newsletter, engages the community on Twitter, and reaches out to community sites and new nephrologists to engage them in research. The Capacity Building Committee conducts webinars to encourage patient partners to develop their own research questions and is developing a hub-and-spoke model to improve research collaboration. LIMITATIONS: We did not conduct formal stakeholder mapping. Only attendees of the visioning workshop provided input, and not everyone's comment or opinion was included in the workshop report. Perspectives were limited to the sample of people who attended the workshop or were surveyed and may not reflect perspectives of all stakeholders in nephrology research in Canada. We did not use formal qualitative methodology to summarize the workshops. IMPLICATIONS: Renewed areas of focus and related committees within the CNTN could lead to an increased capacity for nephrology research, increased engagement and collaboration with researchers, a higher likelihood of funding with rigorous peer review, and more clinical trials and multicenter collaborative prospective research being conducted in Canada.

What Was Known Before

Patients and researchers in the nephrology community saw the value in creating a national network to support nephrology research across Canada through the Canadian Nephrology Trials Network. But both stakeholder groups acknowledged that there was room to improved upon the existing infrastructure.

What This Adds

This report describes how stakeholders identified and created new avenues for improving upon the CNTN to create more robust infrastructure to support trials in Canada.

Background/Purpose of Program

Randomized controlled trials (RCTs) are critical to understanding the causal relationship between interventions and outcomes. Kidney patients are often excluded in big trials, and the number of RCTs in this population lags significantly behind other medical disciplines.[1,2] This led to the establishment of the Canadian Nephrology Trials Network (CNTN) in 2014. The network consisted of researchers in the field of nephrology from across the country who reviewed and provided feedback to investigators on their proposed prospective trials. This was accomplished through regular executive committee meetings and investigator meetings, whereby peers provided support in identifying site investigators for the conduct of multicenter studies.

In 2016, the Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD) network assumed sole responsibility of funding and oversight for the CNTN. Can-SOLVE CKD is 1 of 5 long-term disease networks formed as part of the Canadian Institutes of Health Research (CIHR) Strategy for Patient Oriented Research (SPOR). Can-SOLVE CKD supports initiatives involving a patient-oriented research approach that focus on improving outcomes for patients. This explicitly involves including patients in the design and implementation of the research process. Integrating and expanding CNTN was a key component in the SPOR grant application. Soon after assuming responsibility for the CNTN, Can-SOLVE CKD began seeking ways to expand the network’s capacity, with input from patient partners. This report describes how CNTN and Can-SOLVE members came together to develop a new, collaborative sustainability strategy and vision for the CNTN.

Sources of Information

With funding and additional resources from Can-SOLVE CKD, work began to re-envision the CNTN. Can-SOLVE CKD staff conducted an environmental scan of 11 national and international research networks (Australian Kidney Trials Network, Canadian Cancer Clinical Trials Network, Canadian Critical Care Trials Group, the Canadian Trials Network, Canadian Clinical Trials Coordinating Center, International Society of Nephrology—Advancing Clinical Trials, Canadian Stroke Prevention Intervention Network, CHILDNEPH, Children’s Oncology Group, Children’s Cancer and Blood Disorders (C17), and Canadian Immunization Research Network) to compare and contrast their activities, governance, membership, and patient engagement. The results of the environmental scan are included within the vision workshop report (Supplementary Material 1).

This environmental scan revealed many examples of networks around the world that help build capacity and support quality clinical trials. Other ideas identified from this scan included facilitating collaborations between researchers, helping to develop relationships between researchers and patient partners and facilitating knowledge translation. Four of the 7 networks (Australian Kidney Trials Network, Canadian Cancer Clinical Trials Network, Canadian Critical Care Trials Group, and the Canadian Trials Network) supported quality-investigator-initiated trials by offering support in the development and review of clinical trial protocols, and all 7 networks offered capacity building through the posting of research resources and hosting of educational workshops, webinars, or networking events.

Can-SOLVE CKD then sought to plan a visioning workshop. Can-SOLVE CKD network staff created 2 informal surveys (Supplementary Material 2 and 3) that were distributed prior to the workshop to help inform the agenda and discussion. The questions within the survey were derived from barriers and potential solutions explored in the 2014 workshop. Physician members of the Canadian Society of Nephrology and CNTN were invited by email to complete an online survey on their current use of CNTN offerings and services, as well as their thoughts on the future growth of the CNTN. Can-SOLVE CKD patient partners were invited to complete an online survey on their awareness of clinical trials and involvement in the clinical trials process.

Methods

In September 2018, Can-SOLVE CKD organized a meeting of 44 stakeholders from across Canada for a 2-day visioning workshop in Mississauga, Ontario. Stakeholders included patient partners (N = 11), researchers (N = 22), administrators, funders, and the Ontario Renal Network. The purpose of the workshop was to engage stakeholders in developing a collaborative vision and sustainability strategy for CNTN. Potential participants were identified through existing CNTN membership and Can-SOLVE CKD leadership and staff. The results of the surveys and environmental scan were presented to the attendees to set the stage prior to any discussions at the workshop.

Can-SOLVE CKD staff developed a set of questions, included within Supplementary material 1, intended to generate a dialogue about the future direction of CNTN, including the future focus of the CNTN; the role of the patient partners; the role of industry and the value of CNTN to the Canadian nephrology community. These topics were discussed independently in small groups of 6 participants and then a summary of each group’s discussion was presented to the larger group. This was followed by a Strengths, Weakness, Opportunities, and Threats (SWOT) analysis conducted with the full group to better understand the network’s current state and participants’ visions for growth and development of the network over the next 5 years. Each table had an assigned notetaker who also took notes during the larger group discussions. Summaries were discussed further in large- and small-group sessions over the remainder of the 2-day workshop. Figure 1 shows the information flow and process.

Figure 1.

Workflow diagram showing the flow of information and the process used.

Results/Key Findings

The surveys that were used to inform the visioning workshop were sent out to 12 patient partners, 59 CNTN members and 175 Canadian Society of Nephrology members. In total, 6 patient partners (50%) and 41 nephrologists (23%) completed their respective surveys. The CNTN and Canadian Society of Nephrology responses were pooled and presented as researcher responses.

The survey of Canadian nephrologists showed that peer review was considered a strength within the network (Figure 2). When asked “What are the core strengths of the CNTN?,” 65% of respondents felt that “reviewing clinical trials to improve the quality of science” was the most important core strength. Improving the likelihood of funding for clinical trials, promoting collaboration, enhancing the ability of sites to conduct multisite trials, and mentoring young investigators were also viewed as core strengths. In contrast, only 20% felt strongly or moderately strongly that assisting with enrolment was a core strength.

Figure 2.

Core strengths of Canadian Nephrology Trials Network as reported by researcher respondents on a scale from 1 (not a strength) to 5 (very strong).

With respect to challenges, 74% of researcher respondents indicated that the acquisition of funding was moderately-to-extremely challenging. More than 50% of researchers identified each of the other issues included in the survey as moderately-to-extremely challenging, including the inability to facilitate the conduct of multisite trials, lack of engagement with community sites, lack of skilled research coordinators at sites, and inability to facilitate patient recruitment (Figure 3).

Figure 3.

Main challenges for Canadian Nephrology Trials Network in overcoming barriers to randomized clinical trials as reported by researcher respondents, ranked from most to least challenging.

Researchers endorsed the ideas of a trials registry, which could be searched to find work by a given investigator or trials active at a particular center (71%), a registry of patients interested in clinical trials (68%), and national clinical trials coordinators to assist sites with study start-up (66%) (Table 1). There was also support for the idea that CNTN would provide assistance in training study coordinators for both academic and community sites (46% for both items).

Table 1.

Support for Possible Expanded Services for CNTN as Reported by Researcher Respondents.

Possible expanded CNTN services	Proportion of respondents support this option (41)
Registry of trials searchable by investigator and center	71% (29)
National clinical trials coordinator who could assist local sites with start-up	66% (27)
Registry of patients interested in clinical trials	68% (28)
Training of coordinators to conduct trials	46% (19)
Training of coordinators to recruit at nonuniversity sites	46% (19)
Provide subsidies to community sites	2% (1)
Independent data safety monitoring board for investigator-initiated clinical trials	2% (1)

Note. CNTN = Canadian Nephrology Trials Network.

The results of these surveys allowed Can-SOLVE CKD staff to understand the perspectives of physicians and patient partners and create discussion questions for the visioning workshop.

At the in-person workshop, small groups identified SWOT issues, which were summarized by facilitators and discussed further in large- and small-group sessions. During the SWOT exercise, patient partners also expressed the need to better understand the research process, noting that they would be interested in learning about clinical trials from their physician, websites, social media, and posters in medical offices. This led to the recommendation that the structure and function of the CNTN evolve to increase support to the nephrology clinical trials community within 3 themes: peer review, engagement, and training. These themes were broadened and formally re-named as Scientific Operations, Communications and Engagement, and Capacity Building. Discussions at the visioning workshop identified strengths and opportunities for growth and development within each of these 3 themes.

A workshop report (Supplementary Material 1) was created based on the notes and was distributed to attendees. Committees were created for each of the 3 themes identified in the report: Capacity Building, Communication and Engagement, and Scientific Operations and a new Executive Committee to serve as the governing body of the entire network (Figure 4).

Figure 4.

Change in network structure preworkshop and postworkshop.

In the spirit of patient-oriented research, patient partners are included as members of each of the new committees, and each committee is co-chaired by a researcher and a patient partner. Can-SOLVE CKD emailed the CNTN and Can-SOLVE CKD membership, asking for those interested to apply to be a part of 1 of the 4 committees. The application asked individuals what committee or committees they would like to join, why they wanted to join those committees and whether or not they were interested in being a co-lead. Everyone who applied was appointed to the committee of their choice and offered the role of co-lead if they were interested. The patient partners initially involved in these committees are all affiliated with Can-SOLVE CKD.

All 3 working committees and the executive committee were formed in April 2019 and began monthly meetings. Each committee drafted terms of reference, a workplan and a mandate, which were reviewed and approved by the Executive Committee. The terms of reference set limits on the number of committee members (12 per committee) and the length of time each member serves (generally 2-4 years with an option to extend for 2 years). The network plans to continue to recruit members in preparation for those who may be ending their terms in the next year or 2.

The Scientific Operations Committee

The Scientific Operations Committee aims to improve the quality of research proposals submitted for funding through robust peer review and to provide investigators with prereview and postreview support. Prior to formal submission to a potential funder, investigators can submit near-final research proposals for feedback through the CNTN website and within 6 weeks receive comments and potentially an endorsement letter. If the committee agrees that this research is an important topic for research and that the submitted proposal is a rigorous protocol, investigators receive a letter of endorsement to use in their funding application. The letter describes the importance of the question and the quality of the proposed research and offers support in the promotion of the study and knowledge translation after publication. Each proposal is formally reviewed by 2 researcher members and 1 patient partner member. The committee meets by video conference to discuss the proposal and the reviews. The goal of these discussions is to provide feedback to the applicant to improve the proposal as required and achieve consensus on whether or not to endorse each proposal.

As well, the Scientific Operations Committee initiated a new informal review process aiming to add value earlier in the research cycle, whereby investigators present proposals that are in early development in an online forum to the committee for feedback and assistance. The committee also assists investigators with specific questions or by identifying resources as required.

To become more visible and advance its reach, the Scientific Operations Committee hosted face-to-face events in May and November 2019, as well as 2 virtual research symposium in November 2020 and April 2021. These events were well attended with 37 attendees in Montreal in May 2019 and 26 attendees in Washington, DC in November 2019. The first virtual event, in November 2020, had 50 attendees and the April 2021 virtual event had 34 attendees. The committee plans to hold future annual events in association with the Canadian Society of Nephrology and American Society of Nephrology meetings. These half-day events allow multiple investigators to share ideas, develop potential collaborations, learn from each other’s experiences and expertise, and connect with colleagues. Updates on ongoing trials also offer an opportunity to share insights and experiences.

The Capacity Building Committee

The Capacity Building Committee aims to increase the number of people and resources supporting clinical trials in Canada and to increase the number of research ideas developed by both patient partners and physicians. This committee provides training for patient partners to learn how to develop and present their research ideas at meetings; as well, it connects smaller or community sites to large research sites expand research recruitment capacity through a hub-and-spoke model.

To facilitate the development of patient-driven research ideas, a 3-part webinar series has been created to present patient partners with key points to consider when developing a research idea. Recordings of these webinars are posted on the CNTN website with general viewing access (https://cntn.ca/education/cntn-spring-virtual-research-symposium/). The 3 webinar themes include: “What is research,” “How to develop a research question,” and “Presenting your idea.” The webinars are not meant as a step-by-step guide on how to develop a research question, but act as an introduction and high-level overview of some of the considerations that investigators make in their own development process. This approach aims to entice patients to develop their own idea, with the help of CNTN investigators.

The committee has started work on the development of a hub-and-spoke model in which major research centers act as a hub, with smaller hospitals and community sites as the spokes. The major research hubs will be a point of contact for the spoke sites that wish to participate in research or to recruit and refer to the hub but are unsure of how to get started.

In the future, CNTN plans to mentor trainee researchers by providing resources on our website, promoting training and funding opportunities, and connecting trainees to mentors.

The Communication and Engagement Committee

The Communication and Engagement Committee was created to increase the awareness of the CNTN in the Canadian nephrology community and beyond. This ultimately means increasing membership and facilitating more collaboration with academic and nonacademic sites across Canada, as well as keeping the community informed about what is happening in the Canadian research community.

Communications outreach, primarily through a quarterly newsletter, was developed and currently has a reach of more than 300 contacts. The newsletter promotes CNTN events or other events that would be of interest to the network members; informs readers about ongoing studies and recent publications by network members; and reminds readers about the services offered by CNTN.

In December 2018, the CNTN joined Twitter to increase its visibility, further connect with the research nephrology community and find new members. Currently, the network has 275 followers. Twitter is used to re-tweet research news from network members and kidney research groups across Canada and the world. It is also used to promote CNTN events and the newsletter.

The committee recruits new members from community sites, new researchers and clinical trainees by participating in networking events and by directly emailing individuals who work in nephrology. Over the years, the CNTN members have been primarily research nephrologists, but the network sees the value in including more community nephrologists and other nephrology health care professionals. The Communication and Engagement Committee will be working to reach out to community sites, primarily identified by the Capacity Building Committee members in the course of their work developing the hub-and-spoke model, to see how best to help interested individuals working in nephrology at these sites to engage and participate in nephrology research in Canada.

The Executive Committee

The Executive Committee comprises the co-chairs of each working committee (patient partner and researcher), 6 members at large and 2 non-voting members (Can-SOLVE CKD leadership representative and CNTN project manager). The committee meets quarterly to coordinate the 3 working committees, offer guidance and leadership, and ensure that the network is moving forward in the direction that was set forward at the visioning workshop. Four co-chairs of the Executive Committee report to the Can-SOLVE CKD Steering Committee.

Limitations

The surveys sent to stakeholders had a low response rate, below 50%. The visioning workshop used to identify the key areas of focus in this initiative included stakeholders from across the country; however, the perspectives of our sample of 44 individuals may not be representative of all members of the nephrology community in Canada, which is large, diverse, and dispersed across many regions and disciplines. We did not use formal qualitative methodology to capture the themes emerging from the small- and large-group sessions at the workshop.

Implications

These new committees aim to foster a culture of greater collaboration within Canadian community. The goal is to help the CNTN become a better resource for investigators, patient partners, and collaborators. This will be achieved by helping investigators, through peer review, capacity building, and communications, to design and complete their research, and to disseminate and apply their results.

As Table 2 shows, many initiatives developed by these new committees aim to support the recommendations originally outlined in the re-design of the CNTN. For example, efforts by the Communications and Engagement Committee to upgrade the CNTN website and create a quarterly newsletter will allow the network to better promote studies and disseminate their findings. In addition, the development of the hub-and-spoke model will provide investigators with the support and resources they need to conduct trials across multiple sites. Through these mechanisms, the network aims to increase the capacity of the Canadian nephrology community to complete large collaborative prospective studies that will have a substantial impact on people living with kidney disease and other stakeholders.

Table 2.

Comparison of Rigatto Publication Recommendations and Activities of CNTN Since September 2018.

2015 recommendation	Activities of CNTN since September 2018
To promote a culture of collaboration rather than competition within the Canadian nephrology community	In-person (and virtual) meetings that take place during the Canadian Society of Nephrology (CSN) Annual General Meeting (AGM) and American Society of Nephrology (ASN) Kidney Week are important to the creation of a culture of collaboration
To promote ongoing discussion of clinical trial ideas to develop new studies	Biannual in-person meetings are important in the promotion of a collaborative culture and discussion of clinical trial ideas. The COVID-19 pandemic has hampered these efforts, but we have successfully hosted 2 virtual meetings and will continue these in the future as an accessible way for people to discuss trial ideas
To identify and address barriers to recruitment for ongoing studies	Trialists were invited to present on barriers to recruitment and how they might be overcome at symposium events. We hope to continue this in the future and will invite individuals to present to the network on issues in trial design and implementation
To hold regular face-to-face meetings to accomplish the first 3 goals	CNTN held 2 in person meetings before the COVID-19 pandemic restricted travel. The network will be re-instating these meetings once travel is allowed. At the 2019 meeting in Montreal, there were 37 attendees and at the 2019 meeting in Washington, DC, there were 26 attendees. During COVID-19, virtual events in November 2020 and April 2021, had 50 and 34 attendees, respectively
To develop a web-based system to connect investigators with interested centers across Canada	The website was upgraded to include a listing of investigator-initiated trials across Canada
To develop a central infrastructure of methodologists and coordinators to assist motivated investigators in the development and conduct of multicenter clinical trials	This type of infrastructure may not be something that CNTN can directly build at this time, but the capacity building committee is developing a hub-and-spoke model which will be able to help motivated investigators find the support they need
To promote, prioritize, and facilitate funding of nephrology randomized controlled trials through review and endorsement of protocols and create national and local advocacy for funding high-priority studies	Formal peer-review and endorsement of protocols continues to be a priority task for the CNTN. Through the upgrade of the website and creation of a quarterly newsletter, we are able to better promote studies and their findings

Note. CNTN = Canadian Nephrology Trials Network.

Future Direction

The CNTN is currently supported by Can-SOLVE CKD through a SPOR grant, which ends in 2023, and it is currently uncertain whether a second grant will be funded. To support long-term sustainability regardless of a second grant, the CNTN is looking at collaborations with groups such as KRESCENT and CSN, as well as discussing the idea of engaging with industry partners to continue fostering country-wide collaboration in kidney research. In the meantime and potentially beyond, CNTN will continue to act as a resource for members of the Canadian nephrology community interested in pursuing research. We will continue to engage new investigators and support them in developing relevant and effective proposals, while fostering the work of mid-career and senior investigators. We will develop quality metrics and deliverables to facilitate reporting of our progress in these endeavors.

The research landscape is changing, and the needs of today are not the needs of tomorrow. CNTN will support the growing and dynamic needs of the nephrology research community in Canada.

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Supplemental material, sj-pdf-1-cjk-10.1177_20543581211030396 for Re-Envisioning the Canadian Nephrology Trials Network: A Can-SOLVE-CKD Stakeholder Meeting of Patient Partners and Researchers by Alicia Murdoch, Karthik K. Tennankore, Clara Bohm, Catherine M. Clase, Adeera Levin, Hans Vorster and Rita S. Suri in Canadian Journal of Kidney Health and Disease

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Supplemental material, sj-pdf-2-cjk-10.1177_20543581211030396 for Re-Envisioning the Canadian Nephrology Trials Network: A Can-SOLVE-CKD Stakeholder Meeting of Patient Partners and Researchers by Alicia Murdoch, Karthik K. Tennankore, Clara Bohm, Catherine M. Clase, Adeera Levin, Hans Vorster and Rita S. Suri in Canadian Journal of Kidney Health and Disease

Click here for additional data file.

Supplemental material, sj-pdf-3-cjk-10.1177_20543581211030396 for Re-Envisioning the Canadian Nephrology Trials Network: A Can-SOLVE-CKD Stakeholder Meeting of Patient Partners and Researchers by Alicia Murdoch, Karthik K. Tennankore, Clara Bohm, Catherine M. Clase, Adeera Levin, Hans Vorster and Rita S. Suri in Canadian Journal of Kidney Health and Disease

Click here for additional data file.

Supplemental material, sj-pdf-4-cjk-10.1177_20543581211030396 for Re-Envisioning the Canadian Nephrology Trials Network: A Can-SOLVE-CKD Stakeholder Meeting of Patient Partners and Researchers by Alicia Murdoch, Karthik K. Tennankore, Clara Bohm, Catherine M. Clase, Adeera Levin, Hans Vorster and Rita S. Suri in Canadian Journal of Kidney Health and Disease