Table 1 Barriers and potential solutions to conducting nephrology trials in Canada
Specific barrier | Potential solutions |
|---|---|
Lack of engagement at community sites | |
♦ MD engagement • Site PIs may have no vested interest • Multiple physicians in a shared care clinic model: may not have buy-in from all treating MDs | ⇒ Involve community centers and site PIs earlier in the process (i.e., during protocol development) to get “buy-in”; learn local practices and pitfalls early ⇒ Identify local champions (mentioned repeatedly)—MDs, nurses, allied health, and patients |
♦ Nursing engagement • Treating nurses not engaged | ⇒ Involve local nurses and allied health in steering committee to get buy-in ⇒ CANN-NET Clinical Trials Committee could assist in developing the skill set of local champions |
♦ Patient engagement | ⇒ Advertise studies to patients better ⇒ See below |
♦ Inability to sustain momentum: physicians are busy and the ongoing commitment, time, and effort required to continue participation is often too high | ⇒ Simplify protocols so that minimal time is required (autopilot study) ⇒ Increase role of central/site coordinators to automate management |
♦ Lack of communication between PI and local centers | ⇒ Increase PI presence at the community sites and provide feedback on recruitment success and deliverables—periodic newsletters, recruitment progress tables, personal phone calls, site visits ⇒ It was emphasized that this should not just be emails |
♦ Lack of trained research nurses or coordinators • Not enough work to maintain a full-time research coordinator • Some nurses willing to do part-time RCT work but do not have proper training • Lack of financial support for research nurses | ⇒ Provide CANN-NET central coordinator who could • Provide training/support for part-time personnel • Assist with ethics ⇒ Simplify protocols to reduce workload—decrease follow-up visits, data collection, etc. ⇒ Coordinator from academic site could recruit patients at community centers if distances are not too far—grants should thus budget for travel; facilitate through CANN-NET ⇒ Provide more funding (via grant) to allow research nurse salaries to be in line with clinical salaries ⇒ Hire people on a lower pay-scale for tasks not requiring advanced skill set, e.g., data entry |
Lack of engagement of patients (at all sites) | |
♦ Patients feel trials are a burden; they may feel it is a disruption to their care | ⇒ Present trials as an option for patients to improve their care (similar to the way oncology trials are presented) rather than giving perception that patients are doing investigators a favor ⇒ Engage patients directly through advertising ⇒ Engage patients during protocol development stage ⇒ Conduct focus groups to determine what the barriers are to patient participation; facilitate through CANN-NET ⇒ Get local buy-in from nurses and allied health |
♦ Patients are “trialed out”—same populations for different trials means same patients are being asked again and again | ⇒ See below |
♦ Cognitive and language barriers | ⇒ Understand the impact of these at the local level ⇒ Simplify and translate consent forms ⇒ Central training of coordinators to improve comprehension of trial participation |
Competition and overlap | |
♦ Too many trials in overlapping populations; competition with other trials | ⇒ Local sites could state interests and concentrate participation on a few trials at a given time ⇒ CANN-NET Clinical Trials Committee could assist in matching the right project with the right site (patient population) through web-based registry ⇒ Engage more community sites that are not participating in any trials as yet through CANN-NET |
Onerous Research Ethics Board requirements | |
♦ Separate REB for each site is time and effort consuming | ⇒ CANN-NET should • Advocate for a national REB standard • Advocate for an expedited site review process for protocols approved at a central site |
Language and cultural barriers | |
♦ French sites often left out of trials for this reason and this is a lost opportunity ♦ Limited communication between investigators in and outside Quebec | ⇒ This barrier is often artificial (perceived rather than real) as trial-related materials are often in multiple languages including French; improved communication with centers would assist with this problem ⇒ Trial budgets should include money for translation of materials; this cost is justified by the importance of including Canadians from diverse backgrounds and the increased potential for recruitment ⇒ CANN-NET could assist with translation ⇒ Increase communication, networking, and collaboration between Quebec and other provinces via CANN-NET |
Lack of funding for and prioritization of nephrology trials | |
⇒ Need to increase exposure of importance of renal disease to provincial agencies; e.g., could CANN-NET convince provincial renal agencies to match CIHR/KFoC funding for certain successful grants addressing network priorities? ⇒ National agencies and this CANN-NET network could align efforts to improve branding (advertising, advocates) in order to increase exposure of nephrology disease and nephrology research and secure more funding | |