Evaluating individual participant data plans for ICMJE compliance: A case study at University of Michigan

Abstract

Introduction: The International Committee of Medical Journal Editors (ICMJE) requires researchers to post individual participant data (IPD) plans for interventional clinical trials with registration in order to be eligible for publication in member journals. Objectives: We aimed to gain insight into how researchers interpret these requirements and the related prompts for information used by ClinicalTrials.gov. To accomplish this, we explored the contents of the IPD plans that University of Michigan (U-M) researchers submitted with trial registrations for the first 27 months that the 2019 requirement was in effect. Methods: Clinical trial registration data for U-M was downloaded using the ClinicalTrials.gov API. 198 interventional trials were analyzed using a data collection form to categorize their characteristics and responses to the ClinicalTrials.gov IPD fields. Descriptive statistics were used to examine the data.Results: More than two-thirds of trial registrations (138, 70%) answered “No,” they would not share IPD, while an additional 21 (10%) left the question blank or answered “Undecided.” Only 39 trial registrations (20%) indicated plans to share IPD. Most trials that indicated they would share IPD provided additional information in the other fields in the form.Conclusions: The vast majority (90%) of trials provided an acceptable answer that complies with the ICMJE policy. Additional education and resources from ICMJE would help researchers provide more useful responses in the IPD Sharing Statement fields. Future research includes tracking changes to the information provided in IPD plans and examining how the plans are assessed by ICMJE journal editors.