Article type
Year
Abstract
Background: During this time of infodemics in health, we continue to find that registered trial results are unpublished. In other words, their results are unavailable to the public or healthcare consumers, which weakens available evidence and impedes evidence-based care. This is particularly of concern in places where resources are limited, such as in sub-Saharan Africa (SSA), where evidence about what works can have major implications for cost-effective care.
Objectives: To determine the publication status of registered trials in SSA and to describe their characteristics and assess the association between publishing.
Methods: Using meta-epidemiological cohort methods, we searched clinical trial registry platforms. We conducted a logistic analysis using the available trial data.
Results: We found 14,203 trials registered in SSA since 2010. 20.5% of completed trials did not publish. More than 85% of trials were retrospectively registered. Our logistic regression model showed that trial phase was the only significant predictor of publishing. Odds ratio of publishing: phase-1 (14.4, 95% CI: 8.04–21.89), more likely to publish; phase-2 (0.67, 95% CI: 0.34–1.67); phase-3 (0.34, 95% CI: 0.17–0.67); and phase-4 (0.37, 95% CI: 0.14–0.89) trials, less likely to publish. Important to note, trialists had not updated their trial’s status, results, or both on the trial registry.
Conclusions: It is promising to see that only 79.5% of SSA trials are published, but we need to know how long it takes to publish the trials in journals. Furthermore, we found inconsistencies in reporting trial data on the trial registry platforms. The SSA region, with poor health systems and a substantial disease burden, relies on accurate trial data to address the challenges. Our next step is to conduct a survival analysis to assess the time to publication. Failure to publish trial results soon after completion is a disservice to informing patients, clinicians, and healthcare consumers that rely on up-to-date evidence they can trust. Research needs to be transparent.
Patient, public, and/or healthcare consumer involvement: No involvement in this research. Given the interest in trial data since the COVID-19 pandemic, we welcome consumer feedback.
Objectives: To determine the publication status of registered trials in SSA and to describe their characteristics and assess the association between publishing.
Methods: Using meta-epidemiological cohort methods, we searched clinical trial registry platforms. We conducted a logistic analysis using the available trial data.
Results: We found 14,203 trials registered in SSA since 2010. 20.5% of completed trials did not publish. More than 85% of trials were retrospectively registered. Our logistic regression model showed that trial phase was the only significant predictor of publishing. Odds ratio of publishing: phase-1 (14.4, 95% CI: 8.04–21.89), more likely to publish; phase-2 (0.67, 95% CI: 0.34–1.67); phase-3 (0.34, 95% CI: 0.17–0.67); and phase-4 (0.37, 95% CI: 0.14–0.89) trials, less likely to publish. Important to note, trialists had not updated their trial’s status, results, or both on the trial registry.
Conclusions: It is promising to see that only 79.5% of SSA trials are published, but we need to know how long it takes to publish the trials in journals. Furthermore, we found inconsistencies in reporting trial data on the trial registry platforms. The SSA region, with poor health systems and a substantial disease burden, relies on accurate trial data to address the challenges. Our next step is to conduct a survival analysis to assess the time to publication. Failure to publish trial results soon after completion is a disservice to informing patients, clinicians, and healthcare consumers that rely on up-to-date evidence they can trust. Research needs to be transparent.
Patient, public, and/or healthcare consumer involvement: No involvement in this research. Given the interest in trial data since the COVID-19 pandemic, we welcome consumer feedback.