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.
Highlights
Two of the Research Ethics Boards (REBs) in the province of Quebec refused to approve sponsor access to patient identifying information because (i) the committee considered “the need to provide identifying information to the Canadian Cancer Trials Group and to disseminate it to organizations such as Statistics Canada (StatCan) has not been demonstrated” and (ii) only a small number of patients were eligible at their institutions
The REB recognized data linkage may be an appropriate direction for research conduct but wanted to see more data before approving the approach at their institution
The 140 living participants under follow-up at centers with REB approval who could be reached were invited to enrol in the long-term follow-up study through a combination of in person discussion, telephone discussion and paper mail, depending on center and patient preferences
Summary
A 67-year-old Canadian accountant, walks into the sparse clinic room with his wife and well-maintained ring binder; in it is contained carefully filed blood results, an up-todate medication list, blood pressure readings, and summaries of appointments with all of his health care providers His electronic health care record holds detailed information about his hospital visits, admissions and treatment at this institution, but lacks many occurring at other hospitals, private laboratories and his family doctor’s practice. His private insurance company has specific carefully reviewed data regarding the prescription medication they have reimbursed, and his time off work they have compensated. We can do better at integrating all the valuable information separately held on trial participants
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