(P228) THE HEAVY BURDEN OF LOW-RISK MULTICENTRIC OBSERVATIONAL STUDIES IN CANADA

Background: Congenital cardiology research increasingly involves multicenter collaborations to leverage expertise and combine patient populations, which are essential for studying rare diseases and capture rare events. In Canada, fragmentation of the approval process in multiple jurisdictions and institutions, as well as the absence of a national framework to facilitate multicenter collaborations, places a significant burden on researchers who must navigate across multiple heterogenous institutional requirements, thereby significantly slowing down research processes. The objective of this work was to provide a narrative on the “lessons learned” after initiating multicenter observational studies in Canada.

METHODS AND RESULTS: We reviewed the timelines, barriers and requirements of each step needed for study compliance and approval for the initiation of 4 Canada-wide multicenter low-risk non-interventional studies. These studies were part of the Canadian Congenital and Cardiology Research Network (CCPCRN), which streamlines and harmonizes patient recruitment and data collection, prioritizes online patient recruitment and enables automated data collection via a common research infrastructure to standardize practices.

The studies included in our analyses involved between 14 and 22 Canadian pediatric and adult cardiology institutions, with a combination of both prospective and retrospective designs. While our projects were considered low-risk for the patient, we encountered several barriers related to multiple and sometimes contradictory institutional requests. For example: some institutions required a signed paper consent, refusing to use electronic forms while others found electronic forms practical; some refused to consider online recruitment approaches while others found this approach innovative. One key lesson learned was that institutions have standardized significantly their local and internal processes, leaving little room for flexibility, therefore hampering many inter-institution harmonization processes. Our experience led to five primary considerations when designing a multicenter clinical study. (1) Utilizing existing harmonized REB process is advisable. (2) Flexibility in consent and assent approaches is needed, as requirements between provinces are heterogeneous. (3) A lead research team knowledgeable about institutional policies to support other centers is essential. (4) Providing study guidelines with detailed project and methodology descriptions ensures better standardization across centers. (5) Institutional administrative approval has become the lengthiest step, well above Research ethics board approval, and time buffers should be built into timelines (Figure 1).

Conclusion: Establishing multicenter collaborations demands concentration of resources. While innovative recruitment and data collection methods aim to facilitate research, heterogeneous institutional policies and lack of flexibility are significant barriers. There is optimism that with time, such research projects will become increasingly common and easier to be implemented.