Compliance with International Committee of Medical Journal Editors policy on individual participant data sharing in clinical trial registries: An audit Borana R, Bhaumik S - Perspect Clin Res

Abstract:  

Introduction  

The popularity of open data movement and methodological developments in the conduct of individual participant data (IPD) meta-analysis and secondary analysis has led to increased calls for sharing of IPD of clinical trials.[1] Sharing of adequately deidentified IPD also enhances reproducibility, data quality, and utility. The International Committee of Medical Journal Editors (ICMJE) made it mandatory[2] for all trials, which began enrolling participants from January 1, 2019, to have an IPD data sharing plan. The policy requires the data sharing plan to provide adequate information through answers to a broad question and six subfields. Subsequently, the World Health Organization had added IPD sharing-related fields in the mandatory data field required in its International Clinical Trials Registry Platform (ICTRP) which trialists provide.[3] In this study, we aimed to examine how information on trialists' intent for IPD sharing is captured in different clinical registries globally and if they complied with the ICMJE policy.

   Methods  

 

We audited 18 clinical trial registries (February 21–25, 2022) which were listed as primary registry or data providers in the WHO ICTRP network [Supplementary Data 1 available Online at https://doi.org/10.6084/m9.figshare.20487870.v1]. We extracted data from fields and subfields related to IPD sharing from each of the registries from their publicly available data dictionaries (if available), checked trial registration fields in a mock account, or reviewed at least 10 most recent trial records of that registry for its IPD-related fields. Two auditors independently made decisions (yes or no) on the concurrence of the IPD data requirement of each registry with the IPD data policy of the ICMJE. We resolved disagreement (two such) in a consensus meeting.

 

 

 

 

   Results  

We found that 17 (94.44%) of the 18 registries had a specific field requiring information on sharing of IPD. The European Union Clinical Trials Registry had no field to collect information on IPD statements. There is considerable heterogeneity in the manner of how trialists are required to record IPD data sharing intent in these 17 registries [Supplementary Data 2 available Online at https://doi.org/10.6084/m9.figshare.20487870.v1]. The data captured in relation to IPD sharing complied with the ICMJE policy in only 4 (22.22%) registries – Australian New Zealand Clinical Trials Registry (ANZCTR), Clinical Trials Registry of India (CTRI), Iranian Registry of Clinical Trials (IRCT), and the US trial registry (ClinicalTrials.gov). Trial registries often did not capture one or more of the required data parameters of the ICMJE policy or had a free text option without structuring to capture all requisite data.