Medical Writing Generics and biosimilars ICMJE requirements for sharing individual participant data from interventional clinical trials
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Volume 28, Issue 2 - Generics and biosimilars

ICMJE requirements for sharing individual participant data from interventional clinical trials

Abstract

Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of clinical trial reports in member journals. These requirements are: 1. manuscripts that are based on results of a clinical trial submitted on or after July 1, 2018, must contain a Data Sharing Statement at the manuscript submission stage; and 2. interventional clinical trials that began enrolling participants on or after January 1, 2019, must include a Data Sharing Plan in the trial’s public registration record. The full effect of these data sharing requirements and the resolution with other legal provisions still need to be resolved, especially regarding protection of personal information of clinical trial participants and commercially confidential information for clinical trial sponsors. Nevertheless, sharing of deidentified individual participant data from clinical trials will continue to expand.

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