A Canadian Prospective Study of Linkage of Randomized Clinical Trial to Cancer and Mortality Registry Data

Abstract

In a prospective study, we sought to determine acceptability of linkage of administrative and clinical trial data among Canadian patients and Research Ethics Boards (REBs). The goal is to develop a more harmonized approach to data, with potential to improve clinical trial conduct through enhanced data quality collected at reduced cost and inconvenience for patients. On completion of the original LY.12 randomized clinical trial in lymphoma (NCT00078949), participants were invited to enrol in the Long-term Innovative Follow-up Extension (LIFE) component. Those consenting to do so provided comprehensive identifying information to facilitate linkage with their administrative data. We prospectively designed a global assessment of this innovative approach to clinical trial follow-up including rates of REB approval and patient consent. The pre-specified benchmark for patient acceptability was 80%. Of 16 REBs who reviewed the research protocol, 14 (89%) provided approval; two in Quebec declined due to small patient numbers. Of 140 patients invited to participate, 115 (82%, 95% CI 76 to 88%) from across 9 Canadian provinces provided consent and their full name, date of birth, health insurance number and postal code to facilitate linkage with their administrative data for long-term follow-up. Linkage of clinical trial and administrative data is feasible and acceptable. Further collaborative work including many stakeholders is required to develop an optimized secure approach to research. A more coordinated national approach to health data could facilitate more rapid testing and identification of new effective treatments across multiple jurisdictions and diseases from diabetes to COVID-19.

Representativeness of trial participants: linking the EORTC boost-no boost trial to the Netherlands cancer registry

“…Linkage studies have been shown to be extremely useful in research [17,18], but may come with several challenges related to technical aspects and privacy issues [5]. Moreover, the utility of the linkage may be compromised by bias from linkage errors where records cannot be linked or are incorrectly linked together [3].…”

“…Date of death could not be used as a linkage variable, as discrepancies in survival data between the two databases have been noted. This is due to the EORTC dataset being frozen at the end of the data collection, whereas the NCR is a live database, and the challenges related to long-term follow-up data collection in clinical trials [17]. Given that incomplete linkage can result in biased estimates [3], the one-to-one matching of the de-identified clinical trial records had to be improved to get useful and reliable results.…”

The Past, Present, and Future of Economic Evaluations of Precision Medicine at the Committee for Economic Analyses of the Canadian Cancer Trials Group

“…A goal of CLEO is to use clinical trial and RWE for life-cycle assessment, including for building evidence to support reimbursement decisions, monitoring for appropriate technology implementation, and disinvestment away from low-value technologies [ 14 ]. The CEA is exploring the feasibility, acceptability, and benefit of a national harmonized approach to data, in which administrative and clinical trials can be shared and linked [ 15 ]. Comparison of highly correspondent patient data from administrative and CO.17 databases found that administrative data had longer follow-up and more complete data for certain cost drivers (e.g., hospitalizations) than clinical trial data, supporting the use of the proposed hybrid approach [ 16 ].…”