Modern Research Brings Shift in Data Sharing Policies


Effects of newly implemented NIH policy on data sharing could be profound for clinical research.

Image Credit: © NicoElNino -

Image Credit: © NicoElNino -

A recently published study in The New England Journal of Medicine has brought attention to a shift in the landscape of data sharing—with potentially large implications for clinical research.1 In January 2023, the National Institutes of Health (NIH) officially put into effect its new Data Management and Sharing (DMS) Policy. It requires researchers to share data that were generated with NIH support, promoting greater transparency for the research community.2

“This policy, which was released in October 2020, was developed after many years of stakeholder engagement with a goal of maximizing the return on the public’s investment in research,” the authors wrote.

While there has been a higher need for data sharing in the current landscape, efforts were being made as far back as a decade. According to the study, several large pharma companies created their own clinical trial-data sharing programs. Of note is GlaxoSmithKline’s multi-sponsor platform,, which incorporated data from other pharma giants, such as Roche and Novartis.1

“These initiatives shifted the culture surrounding data sharing in clinical research, and the Institute of Medicine (now the National Academy of Medicine) endorsed data-sharing efforts in its 2015 report Sharing Clinical Trial Data,”3 the authors wrote. “The report also outlined opportunities to maximize the benefits of data sharing—which include avoiding unintentionally duplicative trials, stimulating new research ideas, and enhancing the likelihood that further insights will be gained from the efforts of trial participants and investigators.”

The article also addresses challenges around data sharing. “Data-sharing efforts haven’t been entirely successful, however,” the authors wrote. “Many journals now require data sharing statements in published articles, but studies have shown that authors rarely honor these statements and data generally aren’t made available upon request.”4

Some of the challenges that still exist are the need for a platform that works for all forms of research—not just clinical trials, ensuring that researchers are given to proper resources to maximize data quality, and return on investment from the resources being used to collect data.

“The NIH could consider establishing resources to help ensure responsible data stewardship, such as a platform that allows external investigators to register their studies using short project proposals that pre-specify study objectives, cohort eligibility criteria, primary and secondary outcomes, and statistical analysis plans,” the authors suggest.

In conclusion, the article ultimately envisions a data sharing landscape in which every publicly funded project contributes not only to advancing science, but also to sharing data for broader impact.

“There are clear opportunities ahead, but there is a need for a path forward to guide researchers,” the study authors wrote. “If these efforts are successful, every publicly funded project will have two equally important goals: first, to accomplish its research aims of collecting and analyzing data and reporting results to advance science, and second, to produce data that other investigators can use to replicate findings and produce new insights, thereby accelerating and maximizing the impact of U.S. government funding of science.”


  1. Ross, J. S., Waldstreicher, J., & Krumholz, H. M. (2023). Data Sharing — A New Era for Research Funded by the U.S. Government. The New England Journal of Medicine
  2. National Institutes of Health. 2023 NIH data management and sharing policy. February 17, 2023 (
  3. Institute of Medicine. Sharing clinical trial data: maximizing benefits, minimizing risk. Washington, DC: National Academies Press, 2015.
  4. Gabelica M, Bojčić R, Puljak L. Many researchers were not compliant with their published data sharing statement: a mixed-methods study. J Clin Epidemiol 2022;150: 33-41.

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