In 2016, the International Committee of Medical Journal Editors (ICMJE) took a remarkable step by asserting that medical journals have a vital ethical responsibility to encourage the sharing of clinical trial data.1 This proposal sparked diverse reactions within the research community, yet the momentum toward data sharing has steadily grown across various research landscapes. Recently, ICMJE has taken another significant stride in promoting transparency by announcing that, starting July 1, 2018, all manuscripts detailing findings from interventional clinical trials must include a thorough data sharing statement. Furthermore, any clinical trials beginning participant recruitment on or after January 1, 2019, are required to present a clear data sharing plan during the trial registration process.2

The driving force behind this policy evolution is a heartfelt commitment to enhancing the integrity and transparency of clinical trial design and execution. Recognizing the inherent risks that participants assume by volunteering for clinical trials, it is ethically crucial to foster an environment where researchers are accountable for responsibly sharing deidentified data related to individual participants.

To align with these new data sharing requirements, authors will be asked to incorporate several essential components into their statements. They will need to clarify whether deidentified participant data will be available for sharing and, if so, outline any additional documents that will be accessible, such as the study protocol, statistical analysis plan, and informed consent forms. In addition, authors should specify the types of data that will be made public, the timeframe for availability, and the criteria that govern access. This includes detailing the intended recipients of the data, permissible analyses, and the mechanisms for granting access. For those looking for inspiration, recent publications from The Lancet provide excellent examples of effective data sharing plans that meet these requirements.3

It’s truly heartening to see a segment of the research community beginning to embrace the practice of sharing clinical data with fellow researchers. In support of this critical transition, our journal will introduce a requirement that all submitted manuscripts adhere strictly to the research and publication ethics guidelines set forth by ICMJE. By aligning ourselves with these updated standards, we aim to normalize the practice of sharing deidentified data within the global research community, built upon the collaborative efforts of scientists over the years. This initiative will enhance the invaluable contributions of clinical trial participants, addressing pressing questions in medicine more effectively.

Realizing this collective vision involves a united effort from all stakeholders within the clinical trial ecosystem—including funding bodies, ethics review committees, journals, trialists, data analysts, and, importantly, the trial participants themselves. Each of us must wholeheartedly commit to fostering a culture of transparency and accountability, ensuring that the invaluable data generated from clinical trials significantly contributes to the broader objective of advancing scientific knowledge and improving patient outcomes on a global scale. Let’s celebrate this new era of collaboration and transparency in clinical research, as we work together to harness the power of shared data for the benefit of all.

https://doi.org/10.5051/jpis.2017.47.4.193