Discrepancies in the results reported for multiple sclerosis clinical trials: A comparison between ClinicalTrials.gov and peer-reviewed journals

Author:

Rivero-de-Aguilar Alejandro12ORCID,Pérez-Ríos Mónica34,Mascareñas-García Marta25,Ruano-Raviña Alberto24,Ross Joseph S67,Casal-Acción Beatriz8,Varela-Lema Leonor24

Affiliation:

1. Department of Neurology, University Hospital Complex of Pontevedra, Pontevedra, Spain

2. Department of Epidemiology and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain

3. Department of Epidemiology and Public Health, School of Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain

4. Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain

5. Department of Preventive Medicine, University Hospital Complex of Santiago de Compostela, Santiago de Compostela, Spain

6. Section of General Internal Medicine, Yale School of Medicine, New Haven, CT, USA

7. Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA

8. Axencia Galega de Coñecemento en Saúde (ACIS), Santiago de Compostela, Spain

Abstract

Objective: We aimed to compare the results of phase III and IV clinical trials examining drugs to treat multiple sclerosis (MS) registered at ClinicalTrials.gov to those published in peer-reviewed journals. Methods: After identifying trials registered at ClinicalTrials.gov, consecutive searches were conducted in PubMed, EMBASE and Google Scholar for matching publications. Information regarding participants and efficacy and safety results was extracted and compared. The degree of consistency was classified as ‘concordant’, ‘discrepant’ or ‘not comparable’. The Kaplan–Meier method was used to model time to reporting. Results: In total, 65 trials were appraised. The median time from completion to reporting was shorter for ClinicalTrials.gov (16.4 vs 27.3 months; p = 0.010). Information availability was generally higher in journals except for serious adverse events (SAEs) (86.2% vs 100.0%, p = 0.029) and their description (78.2% vs 100.0%, p < 0.001). However, 45 trials had at least one reporting discrepancy (69.2%). Three studies omitted one or more primary outcomes in the matching journal publication. Regarding safety results, the lowest consistencies were found for causes of death (60.0%) and description of SAEs (27.9%). Conclusion: Consulting both ClinicalTrials.gov and journals increases the accessibility to MS clinical trial results. Some data were frequently missing or disagreed between sources, raising concerns about transparency and generalizability of results.

Publisher

SAGE Publications

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