Errata for trial publications are not uncommon, are frequently not trivial, and can be challenging to access: a retrospective review

Objective: The research sought to determine the prevalence of errata for drug trial publications that are included in systematic reviews, their potential value to reviews, and their accessibility via standard information retrieval methods.Methods: The authors conducted a retrospective review of included studies from forty systematic reviews of drugs evaluated by the Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review (CDR) in 2015. For each article that was included in the systematic reviews, we conducted searches for associated errata using the CDR review report, PubMed, and the journal publishers’ websites. The severity of errors described in errata was evaluated using a three-category scale: trivial, minor, or major. The accessibility of errata was determined by examining inclusion in bibliographic databases, costs of obtaining errata, time lag between article and erratum publication, and correction of online articles.Results: The 40 systematic reviews included 127 articles in total, for which 26 errata were identified. These errata described 38 errors. When classified by severity, 6 errors were major; 20 errors were minor; and 12 errors were trivial. No one database contained all the errata. On average, errata were published 211 days after the original article (range: 15–1,036 days). All were freely available. Over one-third (9/24) of online articles were uncorrected after errata publication.Conclusion: Errata frequently described non-trivial errors that would either impact the interpretation of data in the article or, in fewer cases, impact the conclusions of the study. As such, it seems useful for reviewers to identify errata associated with included studies. However, publication time lag and inconsistent database indexing impair errata accessibility.

ACTIVITIES OF THE PAN-CANADIAN PHARMACEUTICAL ALLIANCE: AN OBSERVATIONAL ANALYSIS

Background The pan-Canadian Pharmaceutical Alliance (pCPA) was established in 2010 to negotiate confidential prices for drugs coming forward from Canada’s centralized health technology assessment (HTA) agency reviews, on behalf of the participating public drug plans. Objective To analyze the activities of the pCPA, to determine: alignment of HTA agency recommendations and pCPA negotiation decisions; the role of health economics in pCPA activities; and patterns of implicit prioritization. Methods The analysis was based on the archive of drugs handled through the pCPA, as posted on its website. The period of observation was from inception to August 31, 2017. HTA recommendations were sourced from the websites of the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review. Descriptive and statistical analyses were conducted. Results The dataset contained 206 drug-indication pairings. There was close but imperfect alignment between HTA agency recommendations and the pCPA’s decisions to negotiate; deviations occurred only with CDR-reviewed drugs. The median incremental cost-effectiveness ratio of negotiated drugs was $168K/QALY for oncology drugs, but $70K/QALY for non-oncology drugs. The time to initiate negotiations was dramatically shorter for oncology versus non-oncology drugs (mean 54 versus 263 days) and also differed between therapeutic areas at CDR. The time required for PCPA activity was surprisingly similar for drugs recommended without a price condition and for those conditional on a price reduction.

PD24 Data Collection By Patient Groups To Provide Patient Input

Introduction:The Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review and pan-Canadian Oncology Drug Review programs incorporate perspectives and experiences from patients and family members who might be affected by the resulting funding recommendation. Perspectives are provided by patient groups who use different approaches to gather patient input.Methods:We analyzed a random sample of ninety-three patient input submissions, drawn from a sampling frame of 532 submissions given to CADTH between June 2010 and June 2016. We looked at how groups described their information gathering methods in the original submissions or the published Clinical Guidance Reports.Results:Approaches were categorized according to whether they involved primary (n = 86) or secondary data collection (n = 130) and further sub categorized according to how data was collected. Primary data included: personal experiences, as described by the submission's author (n = 16); surveys conducted specifically for the submission (n=34); and new interviews of patients and family members on disease and drug experiences (n = 36). Half (forty-seven of ninety-three) of the patient input submissions included experiences of one or more patients who had received the drug under review. Secondary data included: published literature (n = 31); existing surveys (n = 27); past conversations with patients and family members (n = 36); experiences of patient group staff interacting with patients and family members (n = 19); and advice from clinical experts (n = 17). Many patient input submissions (sixty-eight out of ninety-three) reported multiple approaches to collect data. Use of two approaches was most common (thirty-seven out of ninety-three) with five or six approaches used in three of ninety-three submissions.Conclusions:Despite resource and timing challenges, many patient groups gather primary data to share with CADTH and find individuals with experience of the drug under review.

Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis

ObjectivesInvestigate if the recommendations by the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR) to provincial, territorial and federal drug plans about whether to list non-oncology and oncology drug-indication combinations on their formularies are associated with whether the drug-indication combination was approved via the standard evidence pathway or the Notice of Compliance with conditions (NOC/c—limited evidence) pathway.DesignCohort study.Data sourcesWebsites of the CDR and pCODR up to the end of 31 March 2017; journal articles evaluating drugs approved through the NOC/c pathway, the NOC database, the NOC/c website and the Summary Basis of Decision website.InterventionsRecommendations by the CDR and pCODR.Primary and secondary outcome measuresAnalysis of the percent of drugs receiving positive listing recommendations from CDR and pCODR depending on the pathway used to approve the drug.ResultsThere were 310 recommendations for drug-indication combinations from the CDR and 79 from the pCODR. There was a statistically significant difference in the number of drug-indication combinations that received a list versus do not list recommendation from the CDR for those approved through the standard pathway compared with those approved through the NOC/c pathway (p=0.0407). A similar analysis for recommendations from the pCODR was not statistically significant.ConclusionFor non-oncology drug-indication combinations, the type of review appears to influence the recommendation regarding listing on public formularies. This difference may reflect the level of evidence about the efficacy and safety of the drug indication at the time the recommendation was made.

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

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.