Assessment of Consistency Between Peer-Reviewed Publications and Clinical Trial Registries

Abstract

IMPORTANCE Clinical trial registries are intended to increase clinical research transparency by nonselectively identifying and documenting clinical trial designs and outcomes. Inconsistencies in reported data undermine the utility of such registries and have previously been noted in general medical literature. OBJECTIVE To assess whether inconsistencies in reported data exist between ophthalmic literature and clinical trial registries.

Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK

“…An important positive finding was the decrease in the proportion of trials registering retrospectively, a trend that has also been noted by other authors and attributed to rising awareness among researchers of the need to register their trials 23–25. However, our review is consistent with previous reports26 27 that have highlighted inaccurate and incomplete registry entries as a significant cause for concern. This suggests that registries should review their guidance and controls around data entry by researchers to improve the consistency and accuracy of trial records.…”

“…Inaccuracy and incomplete data were often due to a failure by researchers to maintain and update registry entries as has previously been reported 27 49. Although the ISRCTN registry does not provide a template for posting results, it was a reliable source of information about the publication of summary results as it actively followed-up with researchers to confirm the main results’ publications for completed studies.…”

Mapping outcome reporting bias in published non-pharmacological randomized trials: a protocol for a cross-sectional study

“…In this sense, inconsistencies can occur when an outcome is reported in the trial results publication differently than stated in the trial registry, and it is common that the outcome can be stated in one way in the registry and in other way in the study publication (7,18). Selective outcome reporting, major discrepancies and its implications are well studied in the literature (2,8,11).…”

Double-blinded manuscript review: Avoiding peer review bias

“…The rigor of the peer review process remains ironically inconsistent. 9 Multiple tools to protocolize peer review lack validation. 10 Unfortunately, the process of peer review allows the introduction of bias into the publication process.…”