Abstract
Personal health information, including diagnoses and hospital admissions, is routinely collected in administrative databases. Patients enrolling on clinical trials consent to separate collection and storage of their personal health information. We evaluated patient preferences for linking long-term data from administrative databases with clinical trials. Adults with cancer attending outpatient clinics at 3 Ontario hospitals were surveyed about their willingness, when faced with the hypothetical scenario of participating in a clinical trial, to provide potentially identifying information such as initials and date of birth to facilitate long-term research access to normally deidentified publicly collected databases. Of 569 patients surveyed, 335 (59%) were women, 452 (79%) were white, 385 (68%) had a post-secondary education, and 386 (68%) had never participated in a clinical trial. Median age in the group was 59 years. Most participants (93%, cohort 1) would allow long-term access to their information and allow personal information to be used to match clinical trial with administrative data. At the time of clinical trial closure, two thirds of participants (68%, cohort 2) preferred to make additional clinical information available through linkage with administrative databases, and 8 (9%) preferred to have no further information made available to researchers. No significant differences were found in the subset of patients who were part of a clinical trial and those who had never participated (p = 0.65). Almost all patients would allow a clinical trial research team to access their confidential information, providing a more comprehensive assessment of an intervention's long-term risks and benefits.
Highlights
Clinical trials are the “gold standard” by which new health care interventions are tested in a rigorous scientific manner, providing data for regulatory and funding bodies to determine which drugs and devices should be made available to the general population for the betterment of their health
At the time of clinical trial closure, two thirds of participants (68%, cohort 2) preferred to make additional clinical information available through linkage with administrative databases, and 8 (9%) preferred to have no further information made available to researchers
No significant differences were found in the subset of patients who were part of a clinical trial and those who had never participated (p = 0.65)
Summary
Clinical trials are the “gold standard” by which new health care interventions are tested in a rigorous scientific manner, providing data for regulatory and funding bodies to determine which drugs and devices should be made available to the general population for the betterment of their health. Canada’s universal health care system, with its rich administrative and registry databases alongside its world-class expertise in clinical trials[10,11], places it in a prime position to develop a harmonized approach to clinical research. Such an approach offers more than cost savings. We evaluated patient preferences for linking long-term data from administrative databases with clinical trials
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