Poor registration and publication practices in clinical trials of targeted therapeutics for endocrine and metabolic diseases: an observational study

Abstract

Objectives

To assess the completeness and concordance of reporting in registries and corresponding publications of interventional trials on targeted therapeutics for endocrine and metabolic disorders.

Study Design and Setting

We searched clinical trial registries in September 2022 for completed interventional trials of target therapeutics for endocrine and metabolic disorders registered from 2005 onwards. We used ClinicalTrials.gov and the World Health Organization International Clinical Trial Registration Platform registration requirements to extract data and assess the completeness of initial entry and final updates to trial registration and concordance with their published journal articles.

Results

Among 149 clinical trials included, 121 (81%) had corresponding publications. Missing mandatory registration data items were identified in 89 (67%) trials at the initial registration entry, 17 (13%) at the final registration update, and in 85 (77%) corresponding publications. All trials showed changes between initial registration entry and final registration update, and 98% showed changes from the initial registration entry to publication. Changes between initial registration entry and final registration update were most common in the categories ‘Completion date’ (92%), ‘Key secondary outcomes’ (82%), and ‘Date of first enrolment’ (70%). Changes between initial registration entry and publication were most common in categories ‘Sample size’ (91%), ‘Key inclusion and exclusion criteria’ (81%), ‘Key secondary outcomes’ (84%), and ‘Completion date’ (83%).

Conclusion

Despite the legal and journal registration requirements, the completeness and consistency of reporting mandatory data items in registries and corresponding publications regarding targeted therapeutics for endocrine and metabolic disorders are inadequate. Our findings raise questions about the integrity and reliability of clinical trials focusing on targeted therapeutics.

Plain Language Summary

This study evaluated the completeness of reporting of mandatory information about clinical trials of targeted therapies for endocrine and metabolic diseases in trial registries and published articles. Furthermore, we examined whether the information in trial registries aligns with what is reported in scientific journals. Our analysis focused on completed interventional trials registered from 2005 onwards using trial registries. We found that 67% of the included trials were missing mandatory information at the time of initial entry into registry, while 77% of the matching publications also lacked mandatory information. The most common discrepancies between the entry into registry and published data occurred in the mandatory categories of sample sizes and key inclusion and exclusion criteria for participants. Our findings highlight major gaps in how clinical trials for targeted therapies in endocrine and metabolic diseases are conducted. Despite established requirements for accurate registration and publication of mandatory trial information, substantial discrepancies persist between the data in registries and published results. These inconsistencies raise concerns about the reliability of reported findings and underscore the urgent need for improved practices in trial registration and reporting.