An analysis of redactions in Canada’s Common Drug Review Clinical Review Reports and how they relate to the patients’ voice

Abstract

ImportanceCanada’s Common Drug Review (CDR) evaluates drug data from published and unpublished research, as well as input from patient groups, to recommend provincial coverage. Currently, the CDR process gives manufacturers the opportunity to redact information in the final publicly available report. Patients often have strong feelings regarding the efficacy, harms, health-related quality of life (HRQL), and cost associated with the drugs under review and their redacted data. Highlighting Canada’s approach will hopefully build on the growing international concern regarding transparency of clinical study data.ObjectiveThe purpose was to objectively examine and classify completed, publicly available CDR-Clinical Review Reports (CRR) for redactions, and compare them to the patients’ reported interests as patient-centred outcomes.MethodsTwo independent reviewers searched for and examined publicly available CDR-CRR from November 2013-September 2016 through the Canadian Agency for Drugs and Technologies in Health (CADTH) on-line database. Both reviewers separately classified the redactions and patient-reported interests into the following categories: efficacy, harms, HRQL and costs. All discrepancies were rectified by consensus involving a third reviewer.ResultsFifty-two completed CDR-CRR were reviewed. 48 (92%) included patient-reported interests and 40 (77%) had redactions classified in the following categories: efficacy (75%), costs (48%), harms (38%), HRQL (23%). 89% of redactions were outcomes identified as patient-reported interests (69% efficacy, 42% harms, 36% cost, 33% HRQL). When examining drug characteristics, biological agents were statistically associated with increased odds of redactions with respect to either efficacy (OR 3.4, 95% CI 1.0 to 11.6) or harms (OR 3.5, 95% CI 1.02 to 12.4) compared with non-biological agents.ConclusionsWhether data from the CDR-CRR used in the decision-making should be fully disclosed to the public is controversial. Our findings suggest clinical data (efficacy, harms, HRQL) matters to patients and should be publicly available within the CDR-CRR. Canada trails Europe and the USA regarding the transparency of clinical study data. This lack of transparency relates to the patient voice, and limits movement towards patient-centred care and patient-engaged research, restricting real-world value measurement.

Comprehensive value assessment of drugs using a multi-criteria decision analysis: An example of targeted therapies for metastatic colorectal cancer treatment

“…[52] Among these, the patients’ voice and the opinion of the patient group should be given more consideration than is typically the case. [53] Based on the research results, regardless of whether or not the opinions of the patient group or the industry on weights were considered, the final research results remained unaffected. Even so, diverse opinions should make it possible to arrive at more objective, consistent answers.…”

The frequency and availability of population-specific patient reported outcome measures and minimal clinically important differences among approved drugs in Canada

“…Any product with biologic components was coded as biological agent. These definitions have been previously published [4].…”

“…Patient-centered care, shared decision making and evidence based medicine are becoming widely used practices; however, they require objective, unbiased research to be publicly accessible [4]. Wieseler et al [5] found a substantial number of patient-relevant outcomes were missing from the public record, making unbiased trial evaluation challenging.…”