Low Result Reporting Rates Of The Clinical Trial Of Regenerative Medicine For Neurological Diseases Registered On Clinicaltrials.Gov: A Pilot Study Using Four Neurological Diseases

Abstract Sharing the methods and results of clinical trials with full transparency is an ethical obligation of those involved in clinical research. In our previous trend analysis of regenerative medicine clinical trials for stroke, the result reporting rate of trials on gene and/or cell therapy was suspected to be low. Here a pilot study was conducted, the scope of trials based on four neurological diseases using data registered in ClinicalTrials.gov was expanded, and factors affecting the result reporting rate by multivariate analysis were examined using trials on small-molecule compounds and biologics as controls. As a result, stroke as a disease and gene and/or cell therapy as a modality were identified as factors affecting the low reporting rate to ClinicalTrials.gov. However, none of these factors had an inhibitory effect on the journal reporting rate using PubMed as the index. Therefore, these results indicate that disease and modality affected the reporting rate to ClinicalTrials.gov. We believe that further detailed investigation on the effects of disease area and modality on study result reporting rates is warranted.