Evaluating prospective study registration and result reporting of trials conducted in Canada from 2009-2019

Abstract

Background: Adherence to study registration and reporting best practices are vital to foster evidence-based medicine. Poor adherence to these standards in clinical trials conducted in Canada would be detrimental to patients, researchers, and the public alike. Methods: All registered clinical trials on ClinicalTrials.gov conducted in Canada as of 2009 and completed by 2019 were identified. A cross-sectional analysis of those trials assessed prospective registration, subsequent result reporting in the registry, and subsequent publication of study findings. The lead sponsor, phase of study, clinical trial site location, total patient enrollment, number of arms, type of masking, type of allocation, year of completion, and patient demographics were examined as potential effect modifiers to these best practices. Results: A total of 6,720 trials met the inclusion criteria. From 2009-2019, 59% (n=3,967) of them were registered prospectively and 39% (n=2,642) reported their results in the registry. Of the trials registered between 2009-2014, 55% (n=1,482) were subsequently published in an academic journal. Of the 3,763 trials conducted exclusively in Canada, 3% (n=123) met all 3 criteria of: prospective registration, reporting in the registry, and publishing findings. In contrast, of the remaining 2,957 trials with both Canadian and international sites, 41% (n=1,238) had an overall compliance to these three criteria. Overall, the odds of having adherence to all three practices concurrently in Canadian trials decreases by 95% when compared to international trials (OR = 0.05; 95CI: 0.04 – 0.06). Conclusion: Canadian clinical trials substantially lacked adherence to study registration and reporting best practices. Knowledge of this widespread non-compliance should motivate stakeholders in the Canadian clinical trials ecosystem to address and continue to monitor this problem. The data presented provides a baseline against which to compare any improvement in the registration and reporting of clinical trials in Canada.

Structural under-reporting of informed consent, data handling and sharing, ethical approval, and application of Open Science principles as proxies for study quality conduct in COVID-19 research: a systematic scoping review

“…Although our results can be explained by the societal need for rapid answers early in the COVID-19 pandemic, we cannot exclude that the pandemic has exposed and magnified pre-existing trends focused on the quantity of publications instead of high-quality research. Supportive of the latter hypothesis is that almost 20 years ago, it was recognised that we perhaps need fewer publications but more of superior quality 48 49…”

Community consensus on core open science practices to monitor in biomedicine

“…This practice is required by several organizations and funders internationally. Despite clear mandates for registration, we know this practice is not optimal [ 23 ]. Standardized reporting of trial registration will allow for linkage of trial outputs to the registry and help contribute to the reduction of selective outcome reporting and non-reporting.…”

Public reporting of clinical trial findings as an ethical responsibility to participants: a qualitative study

“…gov and completed between 2009 and 2019, found that only 39% of trials had reported results in the registry by early October 2021. 5 Moreover, the problem of non-publication of clinical trials has been documented across many areas of medicine [6][7][8][9][10] and, although more frequent in earlier phase trials, for all phases of clinical trials. 2 Selective reporting of trials has led to less informed patient care, unnecessary harm to patients and a waste of research resources.…”

“…Studies have also found low compliance with regulatory requirements for timely reporting of clinical trial results within ClinicalTrials.gov and the EU Clinical Trials Register 3 4. A study of clinical trials conducted in Canada, including trials registered in ClinicalTrials.gov and completed between 2009 and 2019, found that only 39% of trials had reported results in the registry by early October 2021 5. Moreover, the problem of non-publication of clinical trials has been documented across many areas of medicine6–10 and, although more frequent in earlier phase trials, for all phases of clinical trials 2.…”